GxP Compliance & Regulatory Affairs eLearning Catalog (75 Courses)

Categories:

o Pharmaceutical Regulatory Affairs (15 Courses)
o Clinical Research Regulatory Affairs (24 Courses)
o Medical Device Regulatory Affairs (1 Courses)
o Sales and Marketing (Pharmaceuticals) (4 Courses)
o Drug Safety & Pharmacovigilance (9 Courses)
o Good Manufacturing Practices (12 Courses)
o Electronic Records & Signature (3 Courses)
o Validation (7 Courses)

(There are 15 courses in this category)

Regulatory Affairs: Essentials for Human Medicinal Products – EU and US

Course ID: PRA01
Average Learning Time: 180 minutes
CDP Credits: 3

Start your regulatory affairs journey with a strong foundation in pharmaceutical compliance. This program is ideal for newcomers, offering a comprehensive look at the requirements to gain and maintain approval to market medicinal products in Europe and the USA. You’ll learn about the legal framework, roles of key stakeholders, the drug life-cycle, and the various approval procedures. Updated regularly to reflect regulatory changes, this course is a valuable reference tool for both beginners and experienced professionals.

• Gain a clear understanding of EU and US approval processes
• Learn the roles of key stakeholders and regulatory agencies
• Explore post-marketing obligations and compliance needs
• Stay current with evolving procedures and legislation

Who will benefit from this module?
All staff in the pharmaceutical and biotechnology industries who are inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course. More experienced personnel will find it a useful reference tool. It will also be of benefit to healthcare professionals who contribute to the development of medicinal products.


Objectives:

• Describe the role and responsibilities of regulatory affairs within the pharmaceutical industry in both the EU and the USA.
• Identify the main legislative instruments relating to medicinal products in both the EU and USA.
• Understand the main phases of the drug development process and be aware of the regulatory requirements that apply.
• Describe the requirements for applications for marketing approval and the procedures to be followed in both the EU and USA.
• Identify post-marketing regulatory activities in both the EU and USA.

Outline:
Regulatory affairs primer

This session gives a definition of regulatory affairs and outlines the function and evolution of regulation in the pharmaceutical industry as well as providing a source of key legislation and guidelines. National and international regulatory authorities are introduced including the legal frameworks in the USA and EU.


The life-cycle of a drug

This session looks at the main differences between types of medicinal products, outlines the discovery phase and nonclinical studies and gives a basic introduction to Good Laboratory Practice. It also identifies the four phases of clinical development and introduces some of the special difficulties associated with pediatric trials.


Registering a drug

This session looks at the regulatory requirements during the nonclinical studies phase as well as the salient points of Good Clinical Practice. It also introduces the regulatory processes involved in gaining marketing authorization in the EU and the USA. The session also introduces the learner to orphan drugs, line extensions, generics, naming conventions and compassionate use.


After marketing approval

This session explores post-marketing approval activities, including variations and supplements, line extensions and pharmacovigilance, GMP, basic patent law in the EU and USA, marketing issues, advertising and generics.


Assessment

Multiple-choice mastery assessment.

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Regulatory Affairs: Orphan Drug Application – EU and US

Course ID: PRA02
Average Learning Time: 90 minutes
CDP Credits: 1.5

Unlock the pathway to developing medicines for rare diseases with this specialized course on orphan drug applications. Learn how to secure ‘orphan designation’ in the USA and European Economic Area to access valuable incentives for development. You’ll master the application process, including protocol assistance and data requirements, and gain insight into the Centralized Procedure for marketing authorization in Europe. This is your go-to resource for navigating the complex regulations that make lifesaving treatments for rare conditions possible.

• Understand orphan drug incentives and qualification criteria
• Learn the application process for EU and US submissions
• Explore regulatory pathways, including the Centralized Procedure
• Stay informed on the latest regulatory requirements and impacts

Who will benefit from this module?
This module is intended primarily for regulatory affairs professionals. Staff inexperienced in regulatory affairs and compliance will find the module an invaluable introductory training course; more-experienced personnel will find it a useful reference tool. More generally, it will be of interest to all those involved in the development and registration of medicinal products.

Objectives

• Explain why and how governments encourage the development of medicines for rare human diseases, and identify important sources of information.


• Specify incentives offered for the development of medicines for rare diseases in the USA and in Europe.


• State the criteria for orphan drug designation in the USA and in Europe.


• List the contents of an application for orphan designation in the USA and in Europe, describe how to make an application in each case, and outline the process of review by the regulatory authority.


• Outline the sponsor’s obligations and options after orphan designation in the USA and in Europe.

Outline:
Module overview – An outline of the module’s scope and objectives, and notes on terminology.

Rare diseases and orphan drugs – Development of medicines for prevention, diagnosis, or treatment of rare diseases is commercially unattractive, so governments offer incentives to encourage it. In this session, we introduce the concept of orphan drug designation, discuss how it fits within a product development strategy, and identify some important sources of information on rare diseases and orphan drugs.

US designation – Legislation to encourage research and development of drugs for rare diseases was introduced first in the USA. In this session we describe the US legal framework for orphan drug designation and specify the incentives offered. We set out the criteria for orphan designation and how they should be satisfied. We list the contents of an application for designation and outline how to apply. Finally we identify the sponsor’s obligations and options after designation.

European designation – In this session we describe the European Union’s legal framework for orphan medicine designation and specify the incentives offered. We set out the criteria for orphan designation and how they should be satisfied. We specify the contents of an application for designation, describe how to apply, discuss the procedures for validation and evaluation of the application, and outline the provisions for appeal against refusal of designation. Finally we identify the sponsor’s obligations and options after designation.

Assessment – Multiple-choice mastery assessment.

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Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format

Course ID: PRA03
Average Learning Time: 90 minutes
CDP Credits: 1.5

Master the internationally recognized Common Technical Document (CTD) format with this essential training. Used worldwide for regulatory submissions, the CTD is mandatory in the EEA and USA, and increasingly accepted globally. This course explains the CTD’s rationale, structure, and format, and provides practical guidance on converting existing submissions. A must-have skill for regulatory professionals, this training ensures you’re ready to prepare compliant applications that meet international standards.

• Understand the purpose and structure of the CTD
• Learn formatting and content requirements for submissions
• Gain skills for converting other formats to CTD
• Prepare to achieve a passing score of 75% or more

Who will benefit from this module?
Regulatory affairs and compliance staff, and all those involved in drug development and who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool. Specialists in data handling, knowledge management or documentation will also wish to familiarize themselves with its contents.

Objectives

• Explain the rationale for the CTD, and describe the ways in which it is used.
• Identify regional differences in regulatory requirements for information in a CTD-formatted submission.
• Describe the structure of the CTD.
• Access guidance on detailed structure and content of the CTD.
• Outline formatting requirements for a CTD dossier.
• Convert EU NTA and US NDA section codes and headings to their CTD equivalents.

Outline:
Introduction – This session introduces you to the nature of the Common Technical Document (CTD), a global standard designed by the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). The composition of a regulatory submission team is outlined.

High-level structure – In this session you will become more familiar with the five modules of the CTD.

Fine structure and format – You will be given access to guidelines that specify in detail the structure of each module of the CTD and the relationship between their sections and the documents that make up a dossier. Recommendations are also given on how to segregate and paginate documents and how to format pages, tables of contents and cross-references.

Using the CTD – Different ways in which you can use the CTD in practice are described. Production of a CTD dossier in both paper and electronic format is outlined.

Conversion tools – Two tools allow you to convert section headings in the old EU NTA format or the US NDA format to their equivalents in the CTD.

Assessment – Multiple-choice mastery assessment.

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Regulatory Affairs: Electronic Common Technical Document (eCTD)

Course ID: PRA04
Average Learning Time: 150 minutes
CDP Credits: 2.5

Step into the future of regulatory submissions with the Electronic Common Technical Document (eCTD). This course explains the eCTD specification, which enables global electronic submission, review, and lifecycle management of medicinal product dossiers. You’ll learn how to create eCTD submissions, handle regional dossier differences, and adapt to ongoing specification changes. Perfect for professionals navigating modern regulatory requirements.

• Understand the eCTD specification and its advantages
• Learn creation and submission best practices
• Address regional differences in dossier requirements
• Stay ahead with insights into evolving eCTD standards

Who will benefit from this module?

This module is an essential tool for regulatory affairs and compliance staff and specialists in data handling, knowledge management or documentation. All those involved in drug development and who contribute to regulatory submissions will also wish to familiarize themselves with its contents.

Objectives

• Describe the structure, requirements and functionality of the eCTD.
• Outline XML basics and the architecture of the eCTD.
• Discuss Document Type Definitions (DTDs) and schemas.
• Explain how to build an eCTD.
• Specify regional differences.
• Discuss life cycle and change management.
• List criteria that will make an electronic application technically valid.
• Initiate electronic transfer to a regulatory authority.
• Create, submit and maintain an eCTD dossier throughout the life of a drug product.

Outline:
Introduction – This session defines the eCTD and identifies advantages of using this submission format.

Technical infrastructure – This session gives information on XML specification and style sheets and describes the eCTD backbone.

Directory structure – This session looks at the eCTD hierarchy, life cycle management and structure of the five modules.

Creating an eCTD submission – This session explores the workflow around planning, creating and submitting an eCTD – particularly setting up the modules, and migrating and validating the data.

Special components – Features of the Canadian, EU, Japanese and US DTDs/schemas and the STF specification are outlined.

Tools – This session includes a case study and an eCTD checklist to assist learners when compiling an eCTD submission.

Assessment – Multiple-choice mastery assessment.

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Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies

Course ID: PRA05
Average Learning Time: 180 minutes
CDP Credits: 3

Dive into the specialized world of monoclonal antibody (mAb) regulation. This course addresses unique issues in producing and testing mAbs, covering manufacturing quality, nonclinical, and clinical requirements. Learn regulatory pathways for mAb products in the EU and USA, including CP and BLA submissions. Gain insights into orphan drug status, radiolabeled mAbs, and the impact of new production techniques on the regulatory landscape.

• Understand the complexities of mAb development and regulation
• Explore EU and US approval pathways for mAb products
• Learn requirements for manufacturing, testing, and quality
• Stay informed on advancements impacting mAb regulation

Who will benefit from this module?

This module will benefit regulatory affairs staff and others concerned with the registration of medicinal products based on monoclonal antibodies.

Objectives

• Discuss key quality issues in the manufacture of mAb-based products
  
• Discuss key issues in nonclinical studies of mAb-based products
  
• Discuss key issues in the clinical investigation and use of mAb-based products
  
• Identify specific considerations for radiolabeled mAb-based products
  
• Identify the pathways for applications to conduct clinical trials and to market mAb-based products in Europe and the USA

Outline:
Overview – An outline of the module’s scope and objectives, and notes on terminology.


Quality issues – Quality information requirements for the registration of mAb-based products focus on characterization and specifications in areas such as identity, purity, and potency. Information must be provided on the origin and history of the starting materials, and the manufacturing process and its validation must be thoroughly described. Measures taken and validated to control impurities and to clear viruses and other contaminants need to be set out.


Nonclinical issues – Like other drugs, mAb-based products must undergo laboratory and animal testing to define their pharmacological and toxicological effects before they can be studied in humans. The regulatory framework for nonclinical testing of mAb-based products is essentially similar to that for non-biological drugs. Nevertheless, mAbs present special issues, requiring an adaptable, ad hoc scientific approach to nonclinical testing. In this session, we discuss issues such as studies of cross-reactivity with human tissues, choice of species for nonclinical studies, exposure level, and recipient antibody responses.


Clinical issues – MAbs present issues for clinical development and use, such as assessment of immunogenicity, which typically do not arise for small-molecule medicinal products. This session addresses such characteristic issues.


Radiolabeled mAbs – Monoclonal antibodies may form the basis of radiopharmaceuticals for in-vivo diagnostic use or for radiotherapy. In this session we address characteristics of radiolabeled mAbs.


Regulatory submissions – In this session, we identify the pathways for applications to conduct clinical trials and to market a mAb-based product in Europe and the USA, along with relevant legal statutes, regulations, and regulatory guidance.


Assessment – Multiple-choice mastery assessment.

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Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the USA

Course ID: PRA06
Average Learning Time: 180 minutes
CDP Credits: 3

Learn the complete process for developing and gaining approval for generic drugs in the USA. This course explains the role of the Abbreviated New Drug Application (ANDA), the importance of bioequivalence, and the FDA’s review and approval process. You’ll also explore the impact of the Generic Drug User Fee Amendments (GDUFA) and how to use the FDA’s Orange Book to your advantage.

• Understand the ANDA process and requirements
• Learn how to establish bioequivalence
• Master the FDA review and approval process
• Navigate GDUFA provisions and their impact on industry

Who will benefit from this course?

This module will benefit staff working in regulatory affairs, medical affairs, clinical development, quality/CMC, analytical methods, and quality assurance departments, and other personnel who contribute to the development and registration of generic drugs.

Learning objectives

• List the criteria for therapeutic equivalence of drugs
  
• Outline the types of patent classification for an ANDA submission
  
• Explain how to use the Orange Book in the development of a generic drug
  
• Describe methods for determining bioequivalence of drug products
  
• Outline the content and format requirements for an ANDA submission
  
• Describe the ANDA review and approval process
  
• Outline the provisions of the Generic Drug User Fee Amendments and summarize their effects on generics sponsors

Outline:
Module overview – An outline of the module’s scope and objectives, and notes on terminology.

Generic Drugs and the ANDA – An overview of the legislative and regulatory context for the development and approval of generic drugs, particularly the Hatch-Waxman Act; a summary of the criteria for therapeutic equivalence of drugs; obtaining guidance from the FDA; controlled correspondence.

Patent certification – The role of patent certification in an ANDA submission, the different types of certification, what happens when a patent is challenged, and the circumstances under which marketing exclusivity may be afforded to a generics sponsor.

The Orange Book – The use of the Orange Book in generic drug development, the format and content of the Book’s listings, and how to extract information for an ANDA.

Bioequivalence – The crucial importance of establishing bioequivalence with a reference listed drug; tests of bioavailability and bioequivalence; the statistical criteria for bioequivalence; waivers of in-vivo studies.

ANDA compilation and submission – Planning and managing an ANDA project; regulatory requirements on content and format; quality (CMC), labeling, and bioequivalence information; submitting an ANDA to the FDA’s Office of Generic Drugs.

ANDA review and approval – The process of review by the FDA; review duration and success rate; communication between applicant and FDA; expedited review; petitions; amendments and easily correctable deficiencies; outcomes of review, and the applicant’s options in response to those outcomes.

The Generic Drugs User Fee Amendments – The types of fees that the generics industry must now pay to the FDA; requirements for self-identification of generics industry players; the FDA’s performance goals for review and inspection; changes brought about by GDUFA II.

Assessment – Multiple-choice mastery assessment.

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Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USA

Course ID: PRA07
Average Learning Time: 210 minutes
CDP Credits: 3.5

Gain the skills to successfully prepare and submit an NDA to the FDA. This course walks you through format and content requirements, accelerated approval options, and the review process, ensuring you have the tools to achieve a successful outcome.

• Understand NDA structure and requirements
• Plan submission timelines effectively
• Explore accelerated approval pathways
• Master the review and approval process

Who will benefit from this course?

This module is intended primarily for regulatory affairs professionals who are new to the NDA or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with
the FDA.

Objectives

– Summarize the content and format requirements for a New Drug Application.

– Outline the procedural requirements for an NDA submission to the FDA.

– Describe the role of the FDA in the NDA review and approval process.

– List the principal provisions available from the FDA for expedited drug development and review, and summarize the criteria that apply to them.

Outline:
Overview – Provided in this session is information on the module: the scope, the areas not covered, module objectives and US legislative framework. The background and history of NDAs is also included in this session.

Introduction – This session defines the NDA, outlines the history of related legislation, describes desirable interaction with the FDA, and introduces the US regulatory framework.

High-level content and formatting – This session provides an overview of the fundamental content and format requirements of an NDA for submission to the FDA.

Quality information – The chemistry, manufacturing and controls information that must be detailed in the application is described in this session.

Nonclinical information – The nonclinical information that must be provided in an NDA is summarized in this session.

Clinical information – This session sets out the components of the clinical information required in an NDA.

Administrative information and summary – The administrative and prescribing information and the summaries required in an NDA are outlined.

NDA review and approval process – Details of the FDA’s review and approval process are provided.

Expedited development and review – This session describes priority review, accelerated approval, fast track development, and breakthrough therapy designation.

Assessment – Multiple-choice mastery assessment.

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Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA

Course ID: PRA08
Average Learning Time: 30 minutes
CDP Credits: 0.5

Navigate the complexities of follow-on biologic licensing with this specialized course. Learn about the Biologics Price Competition and Innovation Act, biosimilar and interchangeable criteria, market exclusivity periods, and the Biosimilar User Fee Act.

• Understand the US biosimilar legal framework
• Identify licensing criteria and market exclusivity rules
• Explore patent and regulatory challenges
• Learn the provisions of the Biosimilar User Fee Act

Who will benefit from this module?
This module will mainly benefit regulatory affairs staff concerned with the licensure of follow-on biological products.

Objectives
– Outline the provisions of the Biologics Price Competition and Innovation Act
– Identify criteria for licensure of a follow-on biologic as biosimilar or interchangeable
– Specify periods of market exclusivity applicable to biological medicinal products
– Outline patent infringement issues relevant to biological medicinal products
– Access FDA guidance on development and licensure of follow-on biologics
– Outline the provisions of the Biosimilar User Fee Act
Outline:

• The Biologics Price Competition and Innovation Act.
  
• Biosimilarity and interchangeability
  
• Criteria for licensure as biosimilar
  
• Exclusivity
  
• Patent infringement issues
  
• FDA guidance
  
• The Biosimilar User Fee Act
  
  

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  Regulatory Affairs: The European Centralized Procedure (CP)

  
  Course ID: PRA20
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Master the EU Centralized Procedure, one of the key routes to multinational marketing authorization. Learn about the players involved, the submission stages, timing, and content requirements, plus fast-track provisions and appeals procedures.

  • Understand the Centralized Procedure’s structure
  • Identify mandatory product categories
  • Navigate submission requirements and timelines
  • Prepare for the final assessment with unlimited attempts

  Who will benefit from this module?
  
  This module is primarily aimed at regulatory affairs professionals dealing with marketing authorization applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.
  

  Objectives
  
  -Provide an overview of the CP process.
  -Identify which products may/must use the CP.
  -For products for which the CP is optional, outline the advantages and disadvantages of the CP compared with other routes to marketing authorization.
  -Describe requirements on content, format and timing of submissions.
  -Specify the sequence and duration of the stages of the CP and the responsibilities of the participants.
  -Describe the role of the European Medicines Agency and its relevant competent committee.
  -Outline fast-track provisions.
  -Describe the appeals procedure.
  Outline:
  Module overview – Provides an overview of the content of the module and outlines related courses.
  
  

  An introduction to the Centralized Procedure – This session provides background information. It specifies the types of product for which the CP is mandatory and those for which it is optional. It discusses the types of Marketing Authorization Application, and characteristics of the application procedure.
  
  

  The Centralized Procedure process – This session takes you through the entire process from pre-submission to what happens after an Opinion has been received.
  
  

  Assessment – Multiple-choice mastery assessment.
  

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  Regulatory Affairs: The Mutual Recognition Procedure (MRP)

  
  Course ID: PRA21
  Average Learning Time: 120 minutes
  CDP Credits: 2

  Learn how the MRP converts a national authorization into harmonized authorizations across multiple EEA member states. This course covers roles, timelines, and requirements, as well as special considerations for generic products.

  • Understand the MRP process and requirements
  • Differentiate between MRP and DCP
  • Navigate generic product considerations
  • Leverage guidance from the Coordination Group

  Who will benefit from this module?
  
  This module is primarily aimed at regulatory affairs professionals dealing with marketing authorization applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.
  
  

  Objectives
  
  -Provide an overview of the MRP process.
  -Describe the pre-submission and submission actions in relation to timeline deadlines.
  -Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant.
  Outline:
  Course overview – Provides an overview of the content of the module and outlines related courses.
  
  

  Introduction – This session provides background information. It covers products for which the MRP can be used, the types of Marketing Authorization Application, and characteristics of the application procedure.
  
  

  The MRP process – This session takes you through the entire process from initial national authorization by the RMS to the issuing of national licenses by the CMSs. Referral of issues to the CMD, and the arbitration process, are also covered.
  
  

  Generics and the MRP – This session gives a brief introduction to generics and the special issues that apply to generic products in the MRP.
  
  

  Assessment – Multiple-choice mastery assessment.
  

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  Regulatory Affairs: Variations to Marketing Authorizations in Europe

  
  Course ID: PRA22
  Average Learning Time: 210 minutes
  CDP Credits: 3.5

  Stay compliant with the latest EU rules on variations to marketing authorizations. This course covers classification types, procedures, case studies, and recent legislative amendments.

  • Classify variations and follow correct procedures
  • Apply for variations through CP, DCP, or MRP
  • Stay current with amended EU laws and guidelines
  • Review real-world variation case studies

  Who will benefit from this module?
  
  Regulatory affairs and compliance staff, and all those who contribute to regulatory submissions, will find the module an invaluable introductory training course and/or a useful reference tool.
  
  

  Objectives
  
  – Define the concept of variations to marketing authorizations in the EEA.
  – Identify which type of variation is appropriate for each kind of change to be made.
  – Identify the documentation required to support the variation.
  – Describe how to prepare and submit variation notifications or applications appropriate for each type of variation and route of regulatory approval, including options for grouping of variations and for work sharing of assessment.
  Outline:
  Defining variations – This session identifies and characterizes the different types of variation.
  
  

  Determining variation types – This session looks at the reasons for variations and describes how to identify the type of variation appropriate for each change required.
  
  

  General procedural aspects – This session describes the different routes to regulatory approval of variations, identifies which is appropriate for a given product, specifies the supporting documentation necessary, and describes the provisions for grouping multiple variations into a single submission and for work sharing of regulatory assessment among member states.
  
  

  Variations via the Centralized Procedure – This session describes the processes specific to the submission and processing of variations notifications and applications through the Centralized Procedure.
  
  

  Variations via the Mutual Recognition Procedure – This session describes the processes specific to the submission and processing of variations notifications and applications through the Mutual Recognition Procedure.
  
  

  Case study – A case study of a flawed submission process.
  
  

  Assessment – Multiple-choice mastery assessment.
  

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  Regulatory Affairs: The Decentralized Procedure (DCP)

  
  Course ID: PRA23
  Average Learning Time: 120 minutes
  CDP Credits: 2

  Learn how to use the DCP to gain multinational marketing authorization in the EEA for products with no prior approvals. Explore the process, roles, timelines, and special generic product considerations.

  • Understand DCP requirements and timelines
  • Identify key players and responsibilities
  • Navigate generic product regulations
  • Leverage CMD guidance for success

  Who will benefit from this module?
  This module is primarily aimed at regulatory affairs professionals dealing with marketing authorization applications and related submissions for regulatory approval in Europe. More generally, it will also be of interest to all those involved in the development and registration of medicinal products.
  
  

  Objectives
  – Provide an overview of the DCP process.
  – Describe the pre-submission and submission actions in relation to timeline deadlines.
  – Specify the responsibilities of the Reference Member State (RMS), the Concerned Member States (CMSs) and the applicant.
  Outline:
  Module overview – Provides an overview of the content of the module and outlines related courses.
  
  

  An introduction to the Decentralized Procedure – This session provides background information. It covers products for which the DCP can be used, the types of Marketing Authorization Application, and characteristics of the application procedure.
  
  

  DCP Step 1 – This session takes you through the pre-procedural step and the first assessment stage of the DCP, as far as day 120.
  
  

  DCP Step 2 – This session takes you through the second assessment stage and the final step of issuing national licenses. Referral of issues to the CMD, and the arbitration process, are also covered.
  
  

  Generics and the DCP – This session gives a brief introduction to generics and the special issues facing generics in the DCP.
  
  

  Assessment – Multiple-choice mastery assessment.
  

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  Regulatory Affairs: Essentials of Monoclonal Antibodies

  
  Course ID: PRA24
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Get introduced to monoclonal antibodies and their applications in medicine, diagnostics, and biotechnology. Learn how they work, how they’re made, and the regulations that govern them.

  • Understand the science of mAbs
  • Explore medical and diagnostic applications
  • Learn about manufacturing processes
  • Gain insight into compliance requirements

  Who will benefit from this module?
  This module will benefit anyone educated in science to high school level or beyond who wants an introduction to the basics of monoclonal antibodies.
  
  

  Objectives
  – Describe the structure and function of antibodies in the body
  – Distinguish types of monoclonal antibody by their source and constitution
  – Outline important factors in the production of mAbs
  – Identify major uses of mAbs
  Outline:
  Module overview – An outline of the module’s scope and objectives, and notes on terminology.
  
  

  Structure and functions of antibodies – In this session we discuss the role of natural antibodies and outline how the dream of creating ‘magic bullets’ to fight disease has been realized. We identify the structural components of antibodies and describe their actions. We distinguish types of monoclonal antibody by their non-human and human components. Finally, we sketch how some therapeutic mAbs can be linked to cell-killing agents to increase their effectiveness against cancer.
  
  

  Production of mAbs – Production of a mAb proceeds from the generation of a cell line possessing the mAb’s gene sequence, through bulk cell culture, to isolation and purification of the antibody. In this session we describe options for generation of the cell line, we outline the downstream production processes, and we identify important issues for the assurance of product quality.
  
  

  Uses of mAbs – In this session we describe the wide range of uses for mAbs in laboratory analysis, in-vivo diagnosis and therapy, and purification in the biotechnology industry. We give examples of mAb products in each category of application.
  
  

  Assessment – Multiple-choice mastery assessment.
  

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  Regulatory Affairs: The Biologics License Application (BLA) for Marketing Approval in the USA

  
  Course ID: SUB15
  Average Learning Time: 210 minutes
  CDP Credits: 3.5

  Master the process of obtaining FDA approval for biological products via the BLA. Learn about submission content, format, expedited review options, and regulatory requirements.

  • Understand BLA structure and submission requirements
  • Explore expedited development and review options
  • Learn manufacturing and process control standards
  • Navigate the FDA inspection process

  Who will benefit from this course?
  
  This module is intended primarily for regulatory affairs professionals who are new to the BLA or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA.
  
  
  Learning objectives
  
  – Summarise the content and format requirements for a Biologics License Application
  
  – Outline the procedural requirements for a BLA submission to the FDA
  
  – Describe the roles of the FDA’s Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research in the BLA review and approval process
  
  – List the principal provisions available from the FDA for expedited drug development and review, and summarise the criteria that apply to them
  
  Outline:
  Introduction
  
  In this session we describe the role of the BLA, define biological product, and outline the legal basis of the regulation of such products in the USA. We specify key criteria for licensure of biologics. We identify, by product type, the Centers within the US Food and Drug Administration (FDA) to which a BLA must be submitted for review and approval. We emphasise the importance of good communication between the agency and the sponsor of a BLA before submission. We set out the high-level structure of the electronic Common Technical Document, with which BLA submissions must comply.
  
  
  Quality information
  
  Biologics manufacture involves many complex processes which must be described in the parts of the eCTD concerning quality of the product. In this session we discuss characteristics of biologics manufacture and we outline the chemistry, manufacturing and controls (CMC) information that needs to be included in a BLA.
  
  
  Nonclinical information
  
  In this session we briefly outline the information required on pharmacological actions, toxicological effects, pharmacokinetics, and reproductive toxicity from studies in animals.
  
  
  Clinical information
  
  Module 5 of a BLA, containing clinical information, is the largest and most complex part of the application. The data and analyses it provides are key to the FDA?s understanding of the safety and effectiveness of the biological product. In this session, we describe the components of the information required, according to the categorisation of form FDA 356h.
  
  
  Administrative information and summaries
  
  In this session we discuss Modules 1 and 2 of a BLA. Module 1 contains administrative and prescribing information specific to the USA, including the draft labeling for the product. Module 2 contains summaries and overviews of the quality, nonclinical and clinical information included in Modules 3 to 5 of the application.
  
  
  BLA submission and FDA review
  
  By submission of a BLA to the FDA?s Center for Biologics Evaluation and Research (CBER) or Center for Drug Evaluation and Research (CDER), a sponsor formally proposes that the agency license a new biological product for sale and marketing in the USA. To gain a biologics license the applicant must convince the reviewers that their product is safe, pure and potent. In this extensive session we describe the process of BLA submission and review, including the FDA?s responsibilities and actions, the obligations of the applicant, and the options available.
  
  
  Expedited development and review
  
  The FDA has established several processes that enable patients to gain access to new medicines earlier than would be the case under the normal development and review process. In this session we describe four mechanisms potentially available to sponsors of biological products regulated by CDER or CBER that address unmet medical need in the treatment of a serious condition: priority review, accelerated approval, fast track development, and breakthrough therapy designation. We then discuss the most recently introduced expedited programme, applicable to some products regulated by CBER: regenerative medicine advanced therapy designation.
  
  
  Assessment
  
  Multiple-choice mastery assessment.
  
  
  

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  Regulatory Affairs: The 505(b)(2) Application for Marketing Approval in the USA

  
  Course ID: SUB16
  Average Learning Time: 30 minutes
  CDP Credits: 0.5

  Discover the advantages of the 505(b)(2) pathway, which bridges the gap between full NDAs and generics. Learn how to modify approved drugs, leverage publicly available data, and address unmet medical needs.

  • Understand 505(b)(2) criteria and benefits
  • Differentiate from NDA and ANDA processes
  • Leverage public data for submissions
  • Explore its role in half of all new drug approvals in the USA

  Who will benefit from this module?
  This module is intended primarily for regulatory affairs professionals who are new to the 505(b)(2) application or who seek a refresher course. It will also be of interest to others involved in drug development and/or who interact with the FDA.

  Learning objectives
  – Identify and characterise the four different pathways by which applications for approval to market a small-molecule drug in the USA may be made
  – Compare the 505(b)(2) application with the other pathways to market and identify its advantages
  – Distinguish circumstances that mandate a 505(b)(2) application from circumstances in which it is optional
  – Specify regulatory requirements that apply to 505(b)(2) applications

  Outline:
  In this course, we address issues specific to 505(b)(2) applications. We compare the various pathways and distinguish those circumstances appropriate for a 505(b)(2) NDA from those that are not. We identify particular characteristics of 505(b)(2) applications. We refer the learner to other available courses on NDAs and ANDAs for further details of requirements – for format, content, mode of submission, and FDA review – that are covered there.
  
  

  – Pathways to market approval
  
  – Advantages of 505(b)(2) application
  
  – Application relying in part on published literature
  
  – Application relying in part on FDA findings in a previous approval
  
  – Product modifications compatible with a 505(b)(2) application
  
  – Bioequivalence of sponsor’s drug and reference drug
  
  – Reference drug patent information required
  
  – Market exclusivity for 505(b)(2)-approved products
  
  – Format, content and mode of submission
  
  – Assessment
  
  

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  Clinical Research Regulatory Affairs Courses:

  (There are 24 courses in this category)

  GCP: ICH, Harmonization, and Principles of GCP ICH E6(R3)

  
  Course ID: CT03A
  Average Learning Time: 35 minutes
  CDP Credits: 0

  Step into the world of international clinical research with the confidence to meet-and exceed-global standards. This dynamic course gives you the knowledge to navigate one of the most heavily regulated industries on earth, where globalization has driven the need for harmonized regulations. At the heart of this effort is the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the body behind the gold-standard guideline for Good Clinical Practice (GCP).

  • Understand the ICH’s role in shaping consistent, high-quality research standards worldwide
  • Gain clarity on the requirements that ensure ethical, safe, and scientifically sound trials
  • Meet global expectations for trial authorization and marketing approval submissions
  • Build the skills to confidently apply GCP principles in any research setting

  Module 1 – ICH and Harmonization of Requirements for Clinical Research

  Master the framework that unites clinical trial regulations around the world. This module explores the ICH’s mission, the scope of its harmonization work, and its flagship guideline-ICH E6(R3). Learn why compliance is not only an ethical responsibility but also a legal requirement in many countries, and how alignment with GCP protects trial integrity and patient safety.

  • Discover the origins and purpose of the ICH
  • See how ICH E6 GCP sets the benchmark for ethical and scientific quality
  • Recognize the critical link between compliance and regulatory success
  • Prepare to operate confidently in global, multi-center clinical trials

  Module 2 – Principles of ICH E6(R3) Good Clinical Practice

  Get to the heart of GCP with a deep dive into the reorganized and expanded principles of the E6(R3) revision. This module walks you through each principle and its associated key expectations for conducting clinical research-giving you the insight to translate guidelines into real-world best practices.

  • Understand the updated structure and content of E6(R3)
  • Learn the core ethical, scientific, and quality principles that guide trials
  • Apply key expectations to ensure compliance at every stage of a study
  • Strengthen your role in delivering credible, high-quality clinical data

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

  Learning objectives:
  – Identify factors motivating demand for harmonization of regulations for the drug industry and clinical research.
  – Specify categories of guidelines developed by the ICH
  – Define ICH GCP and state its aims and applicability
  – Identify the latest revision of ICH GCP
  – Identify the 11 principles of GCP set out in ICH E6(R3)
  – Outline the key expectations for clinical research conduct that arise from these principles

  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  – ICH, harmonization

  – Principles of GCP

  – Describes the ICH’s role in the harmonization of regulations.
  
  – Assessment #1.
  
  – Introduces GCP ICH guideline E6(R3)

  – Sets out the principles of GCP.
  
  – Assessment #2.
  
  – Certificate of Completion.
  

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  GCP: Clinical Research Teamwork (Fundamentals)

  
  Course ID: CT03B
  Average Learning Time: 20 minutes
  CDP Credits: 0

  Updated to ICH GCP E6(R3) guidelines, this course empowers learners to master effective teamwork in clinical research. Clinical trials-especially large, late-phase studies-require seamless collaboration between sponsors, investigators, and healthcare professionals. Strong communication is essential to success.

  • Discover the key roles in a clinical research project.
  • Understand responsibilities across teams and stakeholders.
  • Develop skills to foster productive, compliant collaboration.

  Gain the insight needed to build strong partnerships that ensure study quality and regulatory success.

  Who will benefit from this course?
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

  Learning objectives:
  – Identify the major roles in a typical clinical research project
  – Outline the duties of sponsor, investigator, monitor, project manager and study nurse
  – Define contract research organization

  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  – Clinical research teamwork

  – Introduces the major roles in a typical clinical research project

  -Outlines their duties and relationships.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)

  
  Course ID: CT03C
  Average Learning Time: 50 minutes
  CDP Credits: 0

  Updated to ICH GCP E6(R3), this course teaches the critical role of rigorous documentation in proving compliance and ensuring trial integrity. With regulators following the maxim “If it isn’t documented, it didn’t happen,” strong record-keeping is non-negotiable.

  • Learn the essential trial records required by ICH GCP.
  • Understand data governance and integrity principles.
  • Gain best practices for managing data and computerized systems.

  Equip yourself with the knowledge to produce audit-ready, regulator-approved documentation every time.

  Who will benefit from this course?
  
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  
  
  Learning objectives:
  
  – Identify essential records for a clinical trial
  
  – Outline the contents of an investigator’s brochure
  
  – Outline the contents of a trial protocol
  
  – Give examples of source records and data acquisition tools
  
  – Identify trial aspects that are subject to data governance expectations
  
  
  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  – Documentation: Identifies the documents designated by ICH GCP as essential to the conduct of a clinical trial.

  – Describes important examples.

  – Outlines how records should be maintained.
  
  – Final Assessment.
  
  – Certificate of Completion.
  

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  GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)

  
  Course ID: CT03D
  Average Learning Time: 50 minutes
  CDP Credits: 0

  Updated to ICH GCP E6(R3), this course gives sponsors a deep dive into their responsibilities-from trial initiation and management to financing and oversight. The latest revision outlines new expectations for qualifications, agreements, and trial monitoring.

  • Master risk-proportionate approaches to participant protection.
  • Understand sponsor oversight and compliance duties.
  • Learn strategies to ensure reliable, high-quality trial results.

  Become a sponsor who leads trials to success while meeting every regulatory demand.

  Who will benefit from this course?
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

  Learning objectives:
  – Outline GCP expectations for the preparation and design of a clinical trial
  – Summaries the sponsor’s responsibilities for trial oversight
  – Describe the sponsor’s responsibilities for quality management, including risk management, quality assurance and quality control
  – Outline measures to deal with noncompliance
  – Specify the sponsor’s responsibilities for safety assessment and reporting
  – Specify the sponsor’s responsibilities for the quality and supply of the investigational product(s)
  – Outline GCP expectations of the sponsor regarding data and records
  – Describe GCP expectations of the sponsor’s use of computerized systems
  – Describe the sponsor’s responsibilities for statistical programming and data analysis
  – Identify reports required of the sponsor
  
  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  
  – Sponsor responsibilities
  
  
  – Duties and functions discussed in this session.
  
  
  – Risk-based quality management.
  
  
  – Selection of investigators
  
  
  – Trial management.
  
  
  – Data handling.
  
  
  – Record keeping.
  
  
  – Finance.
  
  
  – Compensation.
  
  
  – Regulatory submissions.
  
  
  – Management of investigational product(s).
  
  
  – Safety reporting.
  
  
  – Monitoring.
  
  
  – Audit.
  
  
  – Dealing with noncompliance.
  
  
  – Clinical trial reports.
  
  
  – Final Assessment.
  
  
  – Certificate of Completion.
  
  
  

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  GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities (Fundamentals)

  
  Course ID: CT03E
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Updated to ICH GCP E6(R3), this course is tailored for investigators-the individuals responsible for participant care and trial conduct. You’ll explore every GCP duty, from delegating tasks to managing safety reporting.

  • Understand investigator obligations in detail.
  • Learn best practices for communication with IRB/IEC.
  • Manage investigational products, records, and safety data effectively.

  Lead your clinical trials with confidence, compliance, and care for participants.

  Who will benefit from this course?
  
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  
  
  Learning objectives:
  
  – Summaries GCP expectations for the investigator’s qualifications, resources, and provision of access
  
  – Outline GCP provisions concerning delegation of responsibilities to other persons or service providers
  
  – Specify interactions with the IRB/IEC
  
  – Identify requirements for safety reporting
  
  – Discuss considerations concerning a participant’s cessation of treatment or withdrawal from the trial
  
  – Describe responsibilities for investigational product management
  
  – Specify GCP expectations for records, data integrity, and computerized systems
  
  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  
  – Investigator responsibilities.
  
  
  – Duties and functions discussed.
  
  
  – Provision of adequate resources.
  
  
  – Oversight of delegatees.
  
  
  – Liaison with institutional review boards.
  
  
  – Independent ethics committees.
  
  
  – Compliance with protocol.
  
  
  – Management of investigational product(s).
  
  
  – Informed consent.
  
  
  – Data records.
  
  
  – Safety reporting.
  
  
  – Final Assessment.
  
  
  – Certificate of Completion.
  
  

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  GCP: Informed Consent in Clinical Trials (Fundamentals)

  
  Course ID: CT03F
  Average Learning Time: 20 minutes
  CDP Credits: 0

  This course covers the ethical and regulatory foundation of informed consent-ensuring participants voluntarily join trials with full understanding of risks, benefits, and their rights.

  • Master ICH GCP expectations for informed consent.
  • Address real-world challenges for healthcare professionals and participants.
  • Understand legal considerations and prevent consent-related disputes.

  Gain the tools to protect participants and your research through rigorous, ethical consent practices.

  Who will benefit from this course?
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  
  
  Learning objectives:
  – Discuss the ethical principles underlying ICH GCP expectations for informed consent of trial participants
  – Describe the consent process
  – Specify information to be provided in discussion between healthcare professional and participant, in the informed consent form, and in any supporting document
  – Discuss practical issues for healthcare professionals and participants regarding informed consent
  – Describe circumstances in which third parties may act as proxies for prospective participants in the informed consent process
  
  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  
  – Informed consent
  
  
  – Sets out the principles and requirements of informed consent
  
  
  – Describes the process
  
  
  – Provides examples of practical issues confronting healthcare professionals and subjects.
  
  
  – Final Assessment.
  
  
  – Certificate of Completion.
  
  
  

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  GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities (Fundamentals)

  
  Course ID: CT03G
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Updated to ICH GCP E6(R3), this course equips monitors with modern strategies for ensuring trial quality-from traditional site visits to centralized and remote monitoring approaches.

  • Learn the monitor’s role as the sponsor’s “eyes and ears.”
  • Develop skills for CRF review, source verification, and issue resolution.
  • Understand how to handle noncompliance and close out trials successfully.

  Excel as a monitor who ensures accuracy, compliance, and effective site-sponsor communication.

  Who will benefit from this course?
  
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  
  
  Learning objectives:
  – Summarize the role of monitoring of a clinical trial
  – Identify two main approaches to monitoring
  – Outline the contents of a monitoring plan
  – Specify activities concerning communication with parties conducting the trial
  – Specify activities concerning investigator site selection, initiation, management and close-out
  – Identify aspects of investigational product management that should be confirmed by monitoring
  – Identify monitoring activities concerning clinical trial data
  – Summarize expectations for monitoring reports
  
  Outline:
  Course overview: Sets out the scope, objectives and notes on terminology.
  
  
  – Monitor responsibilities.
  
  
  – Explores the responsibilities of the monitor.
  
  
  – Provides insight into key challenges.
  
  
  – Describes assessment of investigators.
  
  
  – Investigational sites.
  
  
  – Education and trial initiation.
  
  
  – Risk-based monitoring of clinical conduct.
  
  
  – Including CRF review and source document verification.
  
  
  – Trial close-out.
  
  
  – Discusses noncompliance and how to deal with it.
  
  
  – Final Assessment.
  
  
  – Certificate of Completion.
  
  
  

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  Clinical Trials in Drug Development (Fundamentals)

  
  Course ID: CT04A
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Discover the pivotal role clinical trials play in transforming innovative drug concepts into market-ready therapies. This foundational course provides an essential understanding of how clinical trials fit within the drug development cycle, balancing scientific rigor with regulatory demands and financial realities.

  • Understand the increasing global investment in pharmaceutical R&D and why most of it is allocated to clinical trials.
  • Learn how regulatory requirements shape trial design and execution.
  • Explore how financial pressures influence decision-making and trial strategy.
  • Recognize the vital connection between trial quality, regulatory compliance, and market success.

  By completing this course, you will be equipped with the knowledge to appreciate the strategic importance of clinical trials and the factors that drive their success in drug development.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Overview: This session briefly describes the relevant legal documents and guidelines relating to clinical trial design.
  
  – Clinical trials in drug development: The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: Protocol Design (Fundamentals)

  
  Course ID: CT04B
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Step into the critical world of clinical trial protocol design-where strategy meets science! This course empowers clinical research professionals to create protocols that are scientifically sound, ethically responsible, and regulatory compliant. Gain the skills to design studies that deliver accurate, high-quality data while meeting all GCP and regulatory standards.

  • Master key protocol components, including objectives, endpoints, inclusion/exclusion criteria, and methodology.
  • Understand statistical considerations to strengthen study credibility.
  • Align your design with patient safety, feasibility, and regulatory approval requirements.

  By the end, you’ll have the expertise to design protocols that lead to successful trials and market-ready products.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Protocol design: This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: Preparation (Fundamentals)

  
  Course ID: CT04C
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Transform your trial preparation skills and ensure every study starts on the right track! This course guides you through the essential steps for setting up a clinical trial, from regulatory documentation to site readiness and operational logistics. Learn to streamline processes, promote GCP compliance, and anticipate challenges before they occur.

  • Understand the sponsor’s role in ensuring quality and compliance.
  • Prepare sites, teams, and resources for seamless trial initiation.
  • Address ethical, operational, and logistical factors for study success.

  Walk away ready to launch trials with confidence and precision.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Clinical trial preparation: This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: Endpoints (Fundamentals)

  
  Course ID: CT04D
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Endpoints define the story your trial will tell-make sure it’s a compelling one! This course deep-dives into selecting, defining, and managing primary, secondary, and exploratory endpoints that meet regulatory expectations and scientific rigor.

  • Understand how endpoints drive efficacy and safety evaluations.
  • Align endpoint selection with study protocols and analysis plans.
  • Master the documentation and measurement techniques that stand up to regulatory scrutiny.

  Equip yourself to design endpoints that ensure clear, credible, and successful trial outcomes.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Endpoints: This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: Statistical Elements (Fundamentals)

  
  Course ID: CT04E
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Statistics are the backbone of trial credibility-this course ensures you understand and apply them effectively! Learn key statistical concepts that enhance the design, conduct, and interpretation of clinical trials in line with ICH GCP guidelines.

  • Grasp the essentials of randomization, sample size calculation, and hypothesis testing.
  • Interpret p-values, confidence intervals, and their real-world implications.
  • Collaborate effectively with statisticians to safeguard data integrity and validity.

  Finish with the confidence to integrate statistical elements that strengthen every phase of your trial.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Statistical elements: This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Council for Harmonization (ICH) guideline for Good Clinical Practice (GCP).
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: Study Design (Fundamentals)

  
  Course ID: CT04F
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Study design determines trial success-learn to choose the right path! This course covers the main types of clinical trial designs, from randomized controlled trials to observational studies, helping you select the optimal approach for your research goals.

  • Match design types to objectives, populations, and endpoints.
  • Meet ethical, operational, and regulatory considerations in your choice.
  • Enhance feasibility and data quality through strategic design planning.

  Gain the skills to design studies that are both scientifically valid and operationally achievable.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Study design: This session provides an overview of the main types of study design.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: Data Capture (Fundamentals)

  
  Course ID: CT04G
  Average Learning Time: 30 minutes
  CDP Credits: 0

  Data is the lifeblood of clinical research-learn to capture it with accuracy, efficiency, and compliance! This course explores best practices for data collection and management, ensuring your trial data stands up to audits and regulatory reviews.

  • Master secure and compliant data capture methods, including EDC systems.
  • Implement GCP and 21 CFR Part 11 requirements for data integrity.
  • Minimize errors, resolve queries efficiently, and maintain audit-ready records.

  Leave equipped to ensure every data point you collect supports strong, credible trial outcomes.

  Who will benefit from this course?

  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  – Data capture and management: This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.
  
  – Final Assessment.
  
  – Certificate of Completion.
  
  

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  Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation

  
  Course ID: CT11
  Average Learning Time: 120 minutes
  CDP Credits: 2

  Streamline your path to multi-country trial approval with a single electronic application. This course demystifies the EU Clinical Trials Regulation, helping you gain authorization across the EEA efficiently.

  • Follow harmonized procedures for trial approval
  • Use the EU Clinical Trials Information System (CTIS) effectively
  • Understand collaboration among member states for trial evaluation

  Who will benefit from this module?
  
  Regulatory affairs professionals, clinical development staff, and healthcare professionals who sponsor or participate in clinical trials will benefit from this module.
  
  Learning objectives
  

  • Outline the legal and regulatory framework for clinical trials in the European Economic Area
    Describe the characteristics and applicability of the Clinical Trials Regulation
  • Identify online portals and databases essential to authorization and oversight of clinical trials under the Regulation
  • Specify the timeline for transition to the Regulation from the Clinical Trials Directive
  • Identify the contents of a clinical trial application (CTA) dossier as required by the Regulation
  • Describe how to compile and submit a CTA dossier via the Clinical Trials Information System
  • Describe how a CTA is validated and assessed, and how decisions are reached, by the reporting member state and other member states concerned

  
  
  Audience: Regulatory affairs professionals, clinical development staff, healthcare professionals
  
  Category: Clinical trials, regulatory affairs
  
  Region: Europe
  
  Level: Introductory/intermediate
  
  
  Outline:
  The Clinical Trials Regulation and its context
  This session describes how medicines are regulated in the EEA, identifies key characteristics of the Clinical Trials Regulation (CTR), and specifies its applicability to clinical investigations. It identifies EU online portals and databases relevant to clinical trials and describes the Clinical Trials Information System (CTIS), which is essential to the authorization and supervision of trials under the CTR. It discusses the concept of low-intervention clinical trial. Finally, it explains how requirements vary during the period of transition from the Clinical Trials Directive to the CTR.
  
  Making a clinical trial application
  This session explains how to register to use the CTIS, the distinction between Parts I and II of an application, how a reporting member state (RMS) is appointed, and how to make a full or partial submission of a clinical trial application (CTA). It identifies the contents of a CTA dossier and explains how to apply for deferral of publication of certain contents. It describes relationships among the clinical protocol, investigator’s brochure, and investigational medicinal product dossier, and explains where the reference safety information should appear. It also specifies requirements that must be met by clinical and nonclinical data in applications.
  
  Assessment of application
  This session explains how each part of a CTA is validated and assessed by the RMS and other member states concerned (MSCs) in the application. It specifies the sequence of procedures and the deadlines that have to be met by the MSCs and, in the case of requests for information, by the sponsor. It sets out the various decisions on authorization that may be the outcome of assessment.
  
  Assessment
  Multiple-choice mastery assessment.
  
  
  

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  Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation

  
  Course ID: CT12
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Once your trial is approved, maintaining compliance is critical. This course provides the operational know-how to conduct EU-authorized trials successfully.

  • Manage sponsor responsibilities throughout the trial lifecycle
  • Navigate ongoing interactions with member states via CTIS
  • Stay compliant with EU transparency and data requirements

  Who will benefit from this module?
  Regulatory affairs professionals, clinical development staff, and healthcare professionals who sponsor or participate in clinical trials will benefit from this module.

  Learning objectives

  • Access the relevant information on the Clinical Trials Regulation’s requirements for good clinical practice, product manufacture and importation, and product labelling
  • Identify the types of change that can be made to a clinical trial under the Regulation
  • Describe how to apply for authorization of a substantial modification to a trial
  • Outline how to extend a trial to an additional member state of the EEA
  • Identify the types of interactions between sponsor and MSCs that are possible via the Clinical Trials Information System in the management of a trial, and describe circumstances in which the sponsor must respond to requests for information
  • Specify requirements for safety reporting
  • Specify requirements for reporting of trial results

  
  
  
  Level: Introductory/intermediate
  
  Audience: Regulatory affairs professionals, clinical development staff, healthcare professionals
  
  Category: Clinical trials, regulatory affairs
  
  Region: Europe
  
  
  Outline:
  Substantial modifications
  Adding an MSC
  Notifications
  Notices, alerts, and RFIs
  Ad hoc assessments
  Corrective measures
  Reporting adverse events
  Reporting SUSARs
  Annual safety report
  Submitting trial results
  Assessment

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  GCP: ICH-GCP Good Clinical Practice E6(R3)

  
  Course ID: GCP001
  Average Learning Time: 195 minutes
  CDP Credits: 3

  Step into the world of clinical research excellence with our updated ICH-GCP E6(R3) course – the gold standard for ethical, scientific, and quality practices in clinical trials. Gain insider knowledge on the latest revisions, finalized in January 2025, which modernize GCP to reflect decentralized trials, digital technologies, and risk-based approaches. Whether you are a sponsor, investigator, or clinical research professional, this course equips you with the expertise to meet global regulatory expectations and deliver data that stands up to the highest scrutiny.

  • Master the core principles and responsibilities outlined in ICH E6(R3)
  • Understand informed consent best practices and essential documentation
  • Learn directly from a course that meets TransCelerate BioPharma’s recognized GCP training criteria
  • Stay ahead by preparing for the July 2025 implementation deadline

  Who will benefit from this module?
  
  This module will benefit all those who participate in clinical research, whether they work in the pharmaceutical or biotechnology industry or as healthcare professionals. A sound knowledge of GCP is essential for clinical research associates / monitors, project managers, clinical investigators, clinical research coordinators / study nurses, pharmacists, data managers, biostatisticians, and others contributing to clinical trials.
  
  Learning objectives
  

  • Explain why and how the ICH influences clinical research practice through its guideline on Good Clinical Practice (GCP)
  • Identify the principles of GCP
  • Identify records essential to a clinical trial, explain their function and use, outline their contents, and describe their maintenance
  • Comply with GCP expectations for data governance
  • Specify the responsibilities of a trial sponsor
  • Specify the responsibilities of a clinical investigator
  • Explain the rationale and execution of the informed consent process, and identify issues that arise in practice
  • Specify the sponsor’s responsibilities for trial monitoring

  Approximate study time: ~3.5 hours
  
  Level: Introductory/intermediate
  
  Audience: Clinical development and regulatory affairs staff of medicinal products companies and service providers such as contract research organizations; healthcare professionals participating in clinical research
  
  Categories: Clinical trials
  
  Region: Europe, USA, other
  
  Outline:
  Module overview: Sets out the module’s scope, objectives and notes on terminology.
  
  

  ICH, harmonization, and principles of GCP: Among the many guidance documents developed by the ICH, its guideline E6 on Good Clinical Practice is of major importance to all those involved in clinical research. In this session we describe the ICH’s role in the harmonization of regulations, and we introduce its guideline E6 in its latest revision, E6(R3).
  
  

  Records and data governance: Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this session, we describe important examples of records expected to be created and maintained in a clinical trial and which ICH GCP considers to be essential to trial conduct. Regulatory inspectors increasingly focus on issues of data integrity, and ICH E6(R3) includes a new section on data governance measures. We describe the implications of the expectations set out in the guideline for the management of data and computerized systems in clinical research.
  
  

  Sponsor’s responsibilities: The sponsor takes responsibility for the trial’s initiation, management, and the organization of financing. The responsibility of the sponsor entails the implementation of risk-proportionate approaches to ensure the protection of trial participants and the reliability of trial results throughout the clinical trial life cycle. Added in the third revision of ICH GCP are expectations of the sponsor’s resources, qualifications and training of personnel, agreements (including with service providers), and oversight of trials. In this session, we set out the sponsor’s responsibilities in detail.
  
  

  Investigator’s responsibilities: The investigator is the person responsible for the conduct of the clinical trial, including care of the participants for whom they have responsibility. In this session, we describe the investigator’s GCP responsibilities for a range of trial aspects, including delegation of responsibilities, communication with IRB/IEC, safety reporting, investigational product management, and records and data.
  
  

  Informed consent: Informed consent in clinical research is an ethical and regulatory requirement. A research participant must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Prospective participants must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enroll, all potential participants must agree, in writing, to participate. In this session we set out the underlying principles and ICH GCP expectations and provide examples of practical issues confronting healthcare professionals and participants.
  
  

  Monitoring responsibilities: Monitoring is one of the principal quality control activities for a clinical trial. The role of monitoring is evolving, from one focused on investigator site visits and source data verification by monitors, to one embracing a variety of approaches including remote and centralized monitoring and/or in-person visits to investigator sites. In this session, we describe the sponsor’s GCP responsibilities for monitoring of the trial.
  
  

  Assessment: Multiple-choice mastery assessment.
  
  
  

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  Clinical Trials: Preparation and Design

  
  Course ID: GCP002
  Average Learning Time: 240 minutes
  CDP Credits: 4

  Success in drug development begins with smart planning. This course guides you through designing and preparing clinical trials that deliver reliable, high-quality data while keeping costs under control. Learn how to balance scientific rigor with operational efficiency to maximize your research impact.

  • Explore strategies to optimize study design and execution
  • Gain insights into data capture, management, and statistical considerations
  • Understand endpoints, protocol design, and the role of clinical trials in drug development

  Who will benefit from this module?
  This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials.

  Learning objectives

  • Outline the role of clinical trial design in clinical research.
  • Identify the relevant legal documents and guidelines relating to clinical trial design.
  • Recognize the essential statistical components for clinical trial design and how these affect design choice.
  • Define the general principles and concepts for trial design, and describe the implications of design choice on regulatory acceptance.
  • Identify the strategies to improve data capture and management.
  • Describe how electronic data capture can improve clinical trial development.

  Outline:
  Overview: This session briefly describes the relevant legal documents and guidelines relating to clinical trial design.
  
  Clinical trials in drug development: The crucial role of clinical trials in the drug development cycle is examined. Regulatory requirements and financial pressures, and their interaction with trial design, are discussed.
  
  Protocol design: This session provides an overview of clinical trial protocols. Opportunities to improve a clinical trial protocol for regulatory approval are also discussed.
  
  Clinical trial preparation: This session provides an overview of the role of the sponsor in supporting and improving quality in the conduct of clinical trials.
  
  Endpoints: This session focuses on clinical trial endpoints. The purpose of endpoints and the types are discussed in this part.
  
  Statistical elements: This session covers the role of statistics in clinical trial design and analysis, as acknowledged in the International Conference on Harmonization (ICH) guideline for Good Clinical Practice (GCP).
  
  Study design: This session provides an overview of the main types of study design.
  
  Data capture and management: This session describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.
  
  Summary: Key point summary for all topics covered in this online course. Ideal for review, a refresher or consolidation of learning points.
  

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  Clinical Trials and Drug Development

  
  Course ID: GCP003
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Discover how clinical trials fit into the bigger picture of drug development, from concept to market. This course blends history, regulation, and modern-day cost-control measures to give you a comprehensive understanding of the clinical research landscape.

  • Understand the ethical and legislative framework governing trials
  • Learn from historical milestones that shaped today’s trial standards
  • Gain insights into cost pressures in the pharmaceutical industry

  Who will benefit from this module?
  This introductory module is an ideal primer for those new to the fields of clinical research or regulatory affairs. It will also provide valuable background information for administrative, sales and other staff in the pharmaceutical and biotechnology industries, enabling them to understand better the context in which they work.

  Learning objectives

  • Describe the key events in the historical development of the modern pharmaceutical industry.
  • Outline the key codes of practice and regulatory processes.
  • Explain how clinical trials fit within the drug development process.
  • Describe the economic environment within which pharmaceutical companies operate.

  Outline:
  Overview
  The context of the pharmaceutical industry and modern medicine is established. The module’s four perspectives on clinical trials are setout.

  History
  Factors that gave rise to the modern framework of regulation of clinical trials are traced.

  Codes and regulations
  The principal elements of regulation of clinical trials are set out. The regulatory frameworks of the USA, Europe and Japan are outlined. International harmonization of requirements through the work of ICH is discussed, with particular reference to Good Clinical Practice.

  Drug development
  The long and financially risky process of developing a drug is described. The various stages of discovery, nonclinical and clinical development are detailed.

  Global market
  Commercial considerations in drug development are described. Issues such as financial risk, pharmacoeconomics, patent life and generics are discussed.

  Assessment
  Multiple-choice mastery assessment.
  

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  Clinical Trial Monitoring: Site Evaluation and Set-up

  
  Course ID: GCP004
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Ensure your clinical trial starts on the right foot with expert knowledge on site selection and preparation. This module, updated for ICH E6(R3), covers the essential steps in evaluating investigators and institutions to guarantee quality trial execution.

  • Assess site suitability, patient availability, and investigator qualifications
  • Follow proven procedures for trial site preparation
  • Learn the CRA’s role in site monitoring and trial oversight

  Who will benefit from this module?
  The module is primarily aimed at those involved in clinical research and development, in particular the monitoring of clinical trials at the investigational site, and those who require an understanding of what this entails. It and its companion module (Course ID: GCP002) provide a comprehensive introduction to the field for new CRAs/monitors, or additional training and professional development for those already working in the field. Clinical trial administrators and study coordinators who require more training in order to enter the wider CRA employment market will also benefit from the module.

  Learning objectives

  • State the objectives of an investigational site qualification visit and describe how to carry one out.
  • Describe how to prepare for initiation of a clinical trial at an investigational site.
  • State the objectives of a trial initiation visit and describe how to carry one out.

  This course has been updated to reflect the ICH E6(R3) Good Clinical Practice (GCP) Guidelines update.

  Outline:
  Module overview
  Sets out the module’s scope, objectives and notes on terminology.

  Investigational site qualification
  Each candidate investigational site needs to be assessed for its suitability for the trial. A CRA and/or other representatives of the sponsor will typically visit the site to discuss the trial with the potential investigator and learn about the resources that can be deployed there. In this session we describe the objectives of the visit, preparation for it, and its conduct. We set out factors that should be assessed and give examples of the sorts of issues that may arise.

  Preparation for trial initiation
  When one or more investigational sites are approved by the sponsor, various activities are carried out concurrently in preparation for the start of a trial. In this short session we outline the tasks leading up to site initiation.

  Trial initiation at an investigational site
  An initiation visit is made to ensure that the participating site is ready for the conduct of the clinical trial and that the relevant personnel have a clear and accurate understanding of how the study is to be conducted. The CRA will review the clinical protocol and procedures with the team, check that all study materials are in place and that facilities and equipment are ready, ensure that the investigator’s trial master file (TMF) is in order, and confirm the monitoring plan and provisions for audit and inspection. We describe the actions that should be carried out.

  Assessment
  Multiple-choice mastery assessment.

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  Clinical Trial Monitoring: Documentation and Closure

  
  Course ID: GCP005
  Average Learning Time: 180 minutes
  CDP Credits: 2

  From start to finish, proper monitoring ensures trial success. This course teaches how to protect subject welfare, ensure data accuracy, and comply with GCP and regulatory requirements – all the way through trial closeout.

  • Master source document verification and CRF review
  • Identify and address fraud or misconduct
  • Learn step-by-step closeout and documentation procedures

  Who will benefit from this module?
  The module is intended for those involved in clinical research and development, in particular the monitoring of clinical trials, and those who require an understanding of what this entails. It and its companion module CT06 provide a comprehensive introduction to monitoring for new CRAs, or additional training and professional development for those already working in the field. It will also be of value to a clinical research coordinator (CRC), clinical investigator and other healthcare professionals involved in clinical studies.

  Learning objectives

  • Describe how to prepare for and carry out regular monitoring visits to investigational sites.
  • Describe how to review case report forms (CRFs) and verify consistency of data with source documents.
  • Describe how to close out a trial at a site.
  • Discuss the concept and implications of risk-based monitoring.
  • Identify warning signs that raise suspicion of scientific misconduct or fraud.

  This course has been updated to reflect the ICH E6(R3) Good Clinical Practice (GCP) Guidelines update.

  Outline:
  Module overview
  Sets out the module’s scope, objectives and notes on terminology.

  Site monitoring visits
  Regular visiting of investigational sites by a CRA is the front line of clinical trial monitoring. The visits allow face-to-face interaction with study site personnel and direct access to source records and site resources, providing the best opportunity for the CRA both to assess and to influence the progress and quality of a trial. In this session, we discuss monitoring tasks, the frequency and duration of visits, preparation for a visit, the kinds of deficiencies that may be found at the site, interaction with study staff, assessment of protocol compliance in a variety of areas, investigational product and subject recruitment issues, review of findings, and report and follow-up.

  Data checking
  Review and verification of data in CRFs and source documents is considered by many to be the CRA’s principal task. It takes up most of his or her time on a monitoring visit and constitutes the primary measure taken on behalf of the sponsor to assure the quality of the data provided by the investigator. In this session, we describe how to carry out CRF review and source document verification (SDV). We discuss the extent of SDV required, outline differences between paper and electronic CRFs, identify aspects of trial conduct for which CRFs and source records should be checked, discuss on-site corrections and resolution of discrepancies, and outline data retrieval and data query procedures.

  Close-out visit
  Almost all clinical trials require an on-site visit to close the study at a site, irrespective of whether routine monitoring visits have been made. In addition to completing tasks typically carried out at a routine visit, the CRA will be required to perform some actions specific to the end of the trial, such as retrieving or authorizing the destruction of unused supplies, retrieving some essential documents, and reminding the investigator of continuing responsibilities. In this session we describe the close-out of a trial at an investigational site.

  Risk-based monitoring
  Monitoring of clinical research by traditional methods, particularly as regards data checking, is time consuming and laborious. In recent years, regulatory authorities have focused attention on ways of making quality management in general, and monitoring in particular, more efficient through a risk-based approach. Implications of this approach include: increased emphasis on centralized monitoring rather than site visits; and a move away from 100% source document verification toward risk-based and statistically directed sampling of data. In this session we provide a brief introduction to principles of risk-based monitoring.

  Fraud and scientific misconduct
  The great majority of healthcare professionals undertaking clinical research act with honesty and integrity. However, cases of scientific misconduct and downright fraud do occur. Besides damaging the reputations of those who commit them, such actions have potentially serious consequences for the research and might even affect public health. In this session we distinguish error, misconduct and fraud, discuss the CRA’s role in detecting them, and describe their consequences.

  Assessment
  Multiple-choice mastery assessment.
  

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  Clinical Trials: Preparing for an Audit or Inspection

  
  Course ID: GCP006
  Average Learning Time: 150 minutes
  CDP Credits: 2.5

  Audits and inspections don’t have to be stressful – if you’re prepared. This course equips you to meet US FDA and European regulatory expectations with confidence.

  • Understand the scope and purpose of GCP inspections
  • Prepare effectively for both announced and unannounced visits
  • Manage post-inspection actions to maintain compliance

  Who will benefit from this module?
  This module will benefit all those involved in clinical research who already understand the basics of GCP. It will be of value to staff working in clinical, medical and QA departments of pharmaceutical companies and CROs, to independent clinical research associates, and to healthcare professionals conducting clinical studies.

  Learning objectives

  • Discuss principles of GCP inspections and audits
  • Specify activities to be carried out in preparation for an inspection
  • Describe what happens when a European regulator inspects the site of a sponsor or contract research organization
  • Describe what happens when a European regulator inspects the site of a clinical investigator
  • Describe what happens when the US Food and Drug Administration inspects the site of a sponsor or contract research organization
  • Describe what happens when the US Food and Drug Administration inspects the site of a clinical investigator
  • Specify post-inspection actions by the regulator and the inspected party

  Outline:
  Module overview
  An outline of the module’s scope and objectives, and notes on terminology.

  Principles of GCP inspections and audits
  Principles, applicable in any regulatory jurisdiction, of inspections and audits: their purpose, who carries them out, in what circumstances, and their possible consequences; routine versus targeted inspections; system versus study-specific inspections.

  Preparing for an inspection
  Actions you can take to prepare your site for a GCP inspection, whether you work for a sponsor or CRO or as a clinical investigator.

  European regulators’ inspection of sponsor and CRO sites
  Procedure for inspection of the site of a sponsor or CRO by the regulatory authority of a member state of the European Economic Area: pre-inspection provision of an inspection request and plan to the inspectee; quality system inspection; study-specific inspection.

  European regulators’ inspection of investigator sites
  Inspection of legal and administrative aspects, organizational aspects, informed consent provisions, subject data, and management of investigational medicinal products.

  FDA inspection of sponsor and CRO sites
  An outline of pre-inspection activity among the relevant FDA offices is followed by detailed description of what the inspectors examine as regards organization and personnel, study registration, selection and monitoring of investigators, study monitoring, quality assurance, safety and adverse event reporting, data collection and handling, record retention, financial disclosure, computer systems, electronic records and signatures, and investigational product.

  FDA inspection of investigator sites
  An outline of investigators’ legal obligations and the possible scope of an inspection is followed by detailed description of what the inspectors examine as regards authority and administration, clinical protocol, institutional review board, informed consent, source documents, CRFs, financial disclosure, investigational product control, records retention, reports to sponsor, and monitoring.

  Action after an inspection or audit
  This session describes post-inspection actions by regulators, and responses by inspected parties, with particular reference to European and US regulators: meetings at the close of inspections, inspection reports, classification of findings, responses and action plans, post-inspectional correspondence, and possible consequences of serious deficiencies.

  Assessment
  Multiple-choice mastery assessment.

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  Clinical Trials: The Investigational New Drug Application (IND) to Conduct FDA-regulated Clinical Trials

  
  Course ID: GCP007
  Average Learning Time: 180 minutes
  CDP Credits: 3

  Take your investigational drug from the lab to the clinic by mastering the FDA’s IND process. This course provides the tools you need to prepare and submit a complete, compliant application.

  • Learn the required IND content, including protocols and manufacturing data
  • Understand the regulatory review process
  • Bridge the gap from nonclinical to clinical development

  Who will benefit from this module?

  • Regulatory affairs professionals and other staff of pharmaceutical or biotechnology companies involved in clinical development of medicinal products; and
  • Healthcare professionals conducting clinical research as sponsor-investigators or who wish to treat patients under an expanded-access scheme.

  Learning objectives

  • Specify the role of an IND and the contexts in which it is required
  • Access key regulatory documents relating to INDs
  • Describe the contents and format of an IND submission
  • Describe the process of FDA review of an IND, the possible outcomes and sponsor’s responses
  • Identify actions necessary to maintain an active IND
  • Specify options for expanded-access use of investigational drugs

  Outline:
  Module overview
  An outline of the module’s scope and objectives, and notes on terminology.
  
  
  Introduction to Investigational New Drug Applications (INDs)
  This session explains the role and legal status of an IND, sets out the contexts in which one must be filed, summarizes the responsibilities of sponsors and investigators, and outlines the pre-submission process.
  
  
  IND content and format requirements
  This session sets out IND contents required by regulations and describes how these are incorporated in a CTD-formatted submission. The significance of the FDA forms 1571 and 1572 are discussed. The major components of an application are outlined: general investigational plan, investigator’s brochure, clinical protocol, Quality/CMC information, nonclinical data, and clinical information.

  Filing and FDA review
  Options and requirements for submission of an IND are set out, and the review procedure and its outcomes are described. The roles of FDA reviewers are outlined. The significance of a clinical hold and the sponsor’s response to a hold are discussed.

  Maintenance of an IND
  This session identifies the various types of IND amendments and reports: protocol amendments, IND safety reports, annual reports, and information amendments. It explains when they need to be made and outlines the regulations that govern them. The responsibilities of sponsors and investigators to report safety findings are described, as are requirements for financial disclosure and record retention.

  Expanded-access use
  This session describes the various types of expanded-access use of investigational drugs to treat patients outside of clinical trials and sketches a scenario of emergency use.

  Assessment
  Multiple-choice mastery assessment.

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  Clinical Trials: How to Obtain Approval to Conduct Clinical Trials in the EU

  
  Course ID: GCP020
  Average Learning Time: 180 minutes
  CDP Credits: 3

  Navigate the EU’s regulatory landscape with confidence. This course teaches you how to secure both regulatory and ethics committee approval for your clinical trials within the European Economic Area.

  • Compile and submit compliant applications
  • Understand EU Clinical Trials Regulation requirements
  • Prepare for upcoming regulatory changes

  Who will benefit from this module?

  • Regulatory affairs professionals and other staff of pharmaceutical or biotechnology companies involved in clinical development of medicinal products; and
  • healthcare professionals conducting clinical research as sponsor-investigators.

  
  
  It will be of particular value to those who are new to European regulatory affairs, but familiarity with the basics of Good Clinical Practice is assumed.
  
  

  Learning objectives

  • Outline the legal and regulatory framework that governs clinical trials in the European Economic Area
  • Summarize the procedures that must be carried out to gain approval to proceed with a trial
  • Identify the principal components of an application to a national competent authority for clinical trial authorization and describe their contents
  • Discuss the principal areas of concern to an ethics committee and describe the information to be submitted to one
  • Specify what measures must be taken to maintain the authorization of a trial in progress
  • Identify changes that will be brought about by the Clinical Trials Regulation

  Outline:
  Overview
  An outline of the module’s scope and objectives, and notes on terminology.

  The European context
  This session explains the legal and regulatory framework for clinical trials in Europe.

  Applying for approval
  This session outlines the application procedures for clinical trial authorization (CTA) and for ethics committee (EC) favorable opinion. It provides a decision tree through which you can determine whether your prospective investigation is a clinical trial. It describes how to register a trial with the EudraCT database and obtain a EudraCT number. It summarizes the contents of applications and the processes and outcomes of reviews.

  Application for clinical trial authorization
  The contents of a CTA application are discussed in more detail, focusing on the investigator’s brochure, investigational medicinal product (IMP) dossier, circumstances in which a simplified IMPD or Summary of Product Characteristics may be substituted, and other IMP-related data. Online compilation of the application form is explained.

  Application for ethics committee favorable opinion
  Significant features of an application for EC favorable opinion are discussed in more detail, including the clinical protocol, informed consent form, and subject recruitment materials.

  Maintaining authorization
  This session deals with the regulatory compliance activities that have to be carried out once a clinical trial has been approved. It examines the procedure for submitting substantial amendments, safety reporting requirements, and declaration of the end of a trial.

  The Clinical Trials Regulation
  This short session looks forward to the introduction of the Clinical Trials Regulation, which will replace the Clinical Trials Directive and establish greater uniformity in procedures for approval of clinical trials throughout the EEA.

  Assessment
  Multiple-choice mastery assessment.

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  Medical Device Regulatory Affairs Courses:

  (There is 1 course in this category)

  Introduction to the Regulation of Medical Devices

  
  Course ID: MDA0
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Discover the essentials of medical device regulation and gain the knowledge you need to succeed in this rapidly evolving industry. This course introduces the fundamental requirements manufacturers must meet to market devices in Europe and the USA. You’ll explore what qualifies as a medical device, examine a variety of types, and understand the principles and criteria for placing them on the market. Learn about the major global regulatory players, and get up-to-date insights on the current transformation in EU legislation. Whether you’re new to the field or seeking a refresher, this module equips you with the knowledge to navigate device compliance with confidence.

  • Understand global medical device classifications and types
  • Learn the key principles and requirements for marketing approval
  • Stay informed on evolving European and US regulations
  • Identify the major international regulatory odies

  Who will benefit from this module?
  
  
  This module provides essential training for all personnel concerned with the development, regulatory compliance, or marketing of medical devices. It is especially suitable for induction training of entry-level staff.
  
  

  Learning objectives
  
  

  • Define and give examples of the various categories of medical device
    
  • Outline the principles of medical device regulation and the criteria for placing devices on the market
    
  • Identify major players in the regulation of medical devices worldwide
    
  • Identify legal statutes and sources of regulatory guidance on medical devices in the European Union and the USA
    
  • Outline prominent characteristics of the regulation of medical devices in the USA
    
  • Outline prominent characteristics of the regulation of medical devices in the European Economic Area

  
  
  
  Outline:
  Module overview
  An outline of the module’s scope and objectives, and notes on terminology.
  
  

  Medical devices and their regulation
  In this session we explain what medical devices are and how they differ from medicinal products. We define various special categories of such devices. We identify basic principles of their regulation, including risk classification. We outline requirements for technical documentation, clinical data, and post-market surveillance and vigilance. Finally, we identify the major players in regulation.
  
  

  Regulation of medical devices in the USA
  In this session we outline prominent characteristics of the regulation of medical devices in the USA.
  
  

  Regulation of medical devices in Europe
  In this session we outline prominent characteristics of the regulation of medical devices in the European Economic Area.
  
  

  Assessment
  Multiple-choice mastery assessment.
  

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  Sales and Marketing (Pharmaceuticals):

  (There is 4 course in this category)

  Pharmaceutical Sales & Marketing: Legal and Regulatory Framework for Advertising and Promotion of Prescription Drugs in the USA

  
  Course ID: SAM01
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Promote confidently and compliantly. This course demystifies the U.S. legal landscape for prescription drug advertising-covering FDA 21 CFR Part 202, core statutes, and the most influential industry codes-so your campaigns win attention without inviting risk.

  • Identify the agencies, laws, and guidances that govern promotion
  • Understand must-have elements for ads and promotional labeling
  • Recognize common pitfalls and the consequences of non-compliance
  • Build a foundation for compliant HCP and consumer communications

  Advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements, as per FDA 21 CFR Part 202. Advertising and promotion are also subject to guidance from the Food and Drug Administration (FDA) and from industry and professional codes of practice. By identifying the requirements and summarizing the extensive guidance that applies, this course and its companions will help you to advertise and promote your products without incurring legal or regulatory sanctions.

  In this course we set out the legal framework for the regulation of advertising and promotion of prescription drugs in the USA. We identify the regulatory authorities and sources of guidance. We summarize basic requirements that advertisements and promotional labeling must meet, and we identify consequences that may follow failure to comply.

  In companion courses, we deal with regulatory compliance in general, with considerations that are particular to consumer-directed advertising and online promotion, and with certain interactions with healthcare professionals.

  Who will benefit from this module?
  Sales and marketing personnel need to understand the legal and regulatory requirements of Good Promotional Practices (GPP) that must be met when advertising and promoting prescription drugs in the USA. In addition, this module will be of particular benefit to regulatory affairs and legal personnel involved with aspects of marketing.

  Learning objectives:

  • Identify the federal laws and regulatory authorities that govern advertising and promotion of prescription drugs in the USA
  • Identify sources of guidance on such advertising and promotion
  • Distinguish various types of promotional communication
  • Discuss the distinction between advertisement and promotional labeling
  • Specify statutory and regulatory requirements that must be met by promotional communications that make product claims
  • Distinguish various types of advertisement
  • Outline the activities of the offices of the Food and Drug Administration (FDA) that oversee compliance with requirements on advertising and promotion
  • Identify advisory and enforcement actions by the FDA, and other consequences of violations of federal law
  • Specify requirements for submission of promotional materials to the FDA
  • Outline the role of the Office of Inspector General and its compliance program guidance

  Information and Guidance:

  • Advertising and Promotional Labeling Branch of the FDA’s Center for Biologics Evaluation and Research (CBER)
  • FDA 21 CFR Part 202.1, US Code of Federal Regulations on prescription drug advertising
  • PhRMA Code – Pharmaceutical Research and Manufacturers of America Codes
  • REMS – Risk Evaluation and Mitigation Strategy
  • PHS Act – Public Health Service Act

  Outline:

  • Regulation of advertising and promotion of drugs
  • Classifying promotional communications
  • Advertisements and promotional labeling
  • Statutory and regulatory requirements
  • Types of advertisement
  • Misbranding and distribution of an unapproved drug
  • FDA offices
  • FDA advisory and enforcement actions
  • Civil litigation by competitor
  • Submission of communication materials to FDA
  • FDA’s Bad Ad Program
  • Compliance programs and OIG enforcement
  • Provision of samples
  • Assessment

  ---

  Pharmaceutical Sales & Marketing: Regulatory Requirements and Guidance on Advertising and Promotion of Prescription Drugs in the USA

  
  Course ID: SAM02
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Transform rules into results. Learn how to execute compliant promotion across print, digital, events, and sales interactions-translating FDA expectations into practical, high-impact marketing tactics that stand up to scrutiny.

  • Apply FDA guidance to real-world messaging and claim substantiation
  • Operationalize fair balance, risk disclosure, and consistency standards
  • Adapt content for HCP vs. DTC audiences across channels
  • Use review processes that reduce revisions and regulatory exposure

  Advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements. Advertising and promotion are also subject to guidance from the Food and Drug Administration (FDA) and from industry and professional codes of practice. By identifying the requirements and summarizing the extensive guidance that applies, this course and its companions will help you to advertise and promote your products without incurring legal or regulatory sanctions.

  In this course we explain how to advertise and promote prescription drugs in various media, whether to healthcare professionals or consumers, in compliance with legal requirements and guidance from the FDA.

  In companion courses, we set out the legal framework for regulation, and we deal with considerations that are particular to consumer-directed advertising and online promotion and to interactions with healthcare professionals.

  Who will benefit from this module?
  Sales and marketing personnel need to understand Good Promotional Practices (GPP) and the legal and regulatory requirements that must be met when advertising and promoting prescription drugs in the USA. In addition, this module will be of benefit to regulatory affairs and legal personnel involved with aspects of marketing.

  Learning objectives

  • Identify common issues with drug advertising and promotion
  • Specify regulatory requirements for the presentation of brand and non-proprietary names of drugs
  • Emphasize the importance of consistency with prescribing information, and give examples of types of information that are, and types that are not, consistent
  • Describe how to support claims for products in promotional communications
  • Be truthful and not misleading, reveal material facts, and provide fair balance between effectiveness and risks in promotional communications
  • Avoid the pitfalls of: selective presentation of favorable information, broadening or inadequate representation of indications, use of out-of-date information, misuse of statistics, misleading juxtaposition of information, and misbranding of an investigational drug
  • Deal appropriately with endorsements and testimonials
  • Outline the role of the brief summary and adequate information for use in print advertisements and promotional labeling
  • Outline the role of the major statement, and make adequate provision for access to product labeling, in broadcast advertisements
  • Treat comparative claims with care
  • Make comparative promotional claims regarding price, dosing, and indications

  
  

  Information and Guidance:

  • Advertising and Promotional Labeling Branch of the FDA’s Center for Biologics Evaluation and Research (CBER)
  • FDA 21 CFR Part 202.1, US Code of Federal Regulations on prescription drug advertising
  • PhRMA Code – Pharmaceutical Research and Manufacturers of America Codes
  • REMS – Risk Evaluation and Mitigation Strategy
  • PHS Act – Public Health Service Act

  Outline:

  • Common drug advertising and promotion issues
  • Relate brand and established names
  • Frequency of presentation of established name
  • Be consistent with the prescribing information (PI)
  • Information possibly consistent with the PI
  • Information not consistent with the PI
  • Include only substantiated information
  • Be truthful and not misleading, reveal material facts, and provide fair balance
  • Include information on risks
  • Balance risks and effectiveness
  • Reveal other material information
  • Avoid selective presentation of favorable information
  • Endorsements and testimonials
  • Avoid broadening or inadequate representation of indications
  • Use up-to-date information
  • Use statistics carefully
  • Avoid misleading juxtaposition of information
  • Avoid misbranding of an investigational drug
  • Brief summary and adequate information for use in print media
  • Major statement in broadcast ads
  • Make adequate provision for access to product labeling
  • Treat comparative claims with care
  • Comparisons of price, dosing, and indications
  • FDA examples of violative and non-violative ads
  • Assessment

  ---

  Pharmaceutical Sales & Marketing: Consumer-directed Advertising and Online Promotion of Prescription Drugs in the USA

  
  Course ID: SAM03
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Lead in DTC and digital. This course shows you how to design consumer-facing and online campaigns that are creative, measurable, and compliant-from TV spots to social media and influencer engagement.

  • Meet DTC-specific requirements while protecting brand trust
  • Implement compliant web, mobile, and social content workflows
  • Craft clear ISI, risk, and fair-balance presentations for consumers
  • Leverage analytics and moderation plans that satisfy regulators

  Advertisements and promotional labeling of prescription drugs in the USA must comply with statutory and regulatory requirements. Advertising and promotion are also subject to guidance from the Food and Drug Administration (FDA) and from industry and professional codes of practice. By identifying the requirements and summarizing the extensive guidance that applies, this course and its companions will help you to advertise and promote your products without incurring legal or regulatory sanctions.

  Unlike the great majority of other countries, the advertising of prescription drugs directly to consumers is permitted in the USA. Spending by drug companies on direct-to-consumer (DTC) advertising of prescription drugs has increased more than four-fold over two decades, with a dramatic increase in the number of TV ads. In addition, the Internet and social media platforms have increasingly enabled companies to engage more actively with the public.

  In addition to those that apply to all advertising and promotion of prescription drugs, specific regulatory requirements and industry/regulatory guidance apply to DTC advertising and promotion, including online promotion, and we discuss these in this course.

  Who will benefit from this module?
  
  Sales and marketing personnel need to understand Good Promotional Practices (GPP) and the legal and regulatory requirements that must be met when advertising and promoting prescription drugs in the USA. In addition, this module will be of benefit to regulatory affairs and legal personnel involved with aspects of marketing.
  
  

  Learning objectives:
  

  • List types of information generally expected to be included in consumer-directed communications
  • Specify modified regulatory requirements for DTC communications in print media
  • Access FDA guidance on presenting quantitative efficacy and risk information in DTC communications
  • Summarize statutory requirements and FDA guidance on presentation of the major statement in broadcast advertisements, and outline the response of an industry advocacy group
  • Specify ways of making adequate provision, in broadcast ads, for access to product labeling
  • Comply with statutory requirements and FDA recommendations on pre-dissemination submission of broadcast ads to the agency for review, and outline FDA enforcement actions for non-compliance
  • Access guiding principles, from the Pharmaceutical Research and Manufacturers of America, on DTC advertising
  • Identify sponsors’ responsibilities for interactive promotional media
  • Submit interactive promotional media to the FDA in compliance with the agency’s draft guidance
  • Respond, in compliance with FDA draft guidance, to unsolicited requests for off-label information
  • Comply with FDA draft guidance on how sponsors should deal with promotional communications in online media that impose limits on the number of text characters that can be used
  • Correct online misinformation by independent third parties, in compliance with FDA draft guidance

  
  

  Information and Guidance:

  • Advertising and Promotional Labeling Branch of the FDA’s Center for Biologics Evaluation and Research (CBER)
  • FDA 21 CFR Part 202.1, US Code of Federal Regulations on prescription drug advertising
  • PhRMA Code – Pharmaceutical Research and Manufacturers of America Codes
  • REMS – Risk Evaluation and Mitigation Strategy
  • PHS Act – Public Health Service Act

  Outline:
  Direct-to-consumer (DTC) advertising
  

  The big picture
  • Information generally expected in DTC ads
  • Modified requirements for communications in print media
  • Omit some prescription information
  • Use consumer-friendly language
  • Presenting quantitative efficacy and risk information
  • Broadcast advertisements
  • Major statement
  • Adequate provision
  • Pre-dissemination review of television advertisements
  • PhRMA Guiding Principles

  
  
  Online promotion
  

  • Static versus interactive communications
  • Responsibility for interactive promotional media
  • Requirements for submission of interactive promotional media
  • Responding to unsolicited requests for off-label information
  • Media with character space limitations
  • Correcting independent third-party misinformation
  • Assessment

  ---

  Pharmaceutical Sales & Marketing: Marketing of Prescription Drugs in the USA- Interactions with Healthcare Professionals

  
  Course ID: SAM04
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Engage HCPs ethically-and effectively. Learn the legal boundaries and best practices for field interactions, speaker programs, grants, and transfers of value to minimize Anti-Kickback and False Claims risk while maximizing educational impact.

  • Navigate AKS, FCA, and promotional rules with confidence
  • Design compliant speaker programs, samples, and detailing
  • Implement robust documentation and Sunshine Act reporting
  • Adopt codes of conduct that elevate reputation and performance

  The heaviest legal penalties imposed on drug companies concern interactions with healthcare professionals in the context of prescription drug marketing, notably for violations of the Anti-Kickback Statute and the False Claims Act. Monetary penalties have amounted to billions of dollars in some cases.

  Payments or other transfers of value made to certain healthcare professionals or teaching hospitals must be reported to the government. In addition, company-sponsored speaking programs and detailing by sales representatives must comply with provisions of the Federal Food, Drug, and Cosmetic Act on advertising and promotion. Industry guidance urges drug companies to follow the highest ethical standards as well as all legal requirements. In this course we identify the laws and guidance that apply, and we provide information that will help companies to market their products without incurring penalties.

  In companion courses on marketing of prescription drugs in the USA, we deal with the legal and regulatory framework for advertising and promotion of drugs, with general regulatory compliance in that context, and with considerations that are particular to consumer-directed advertising and online promotion.

  Who will benefit from this module?
  
  Sales representatives and marketing personnel need to understand Good Promotional Practices (GPP) and the legal and regulatory requirements that must be met, and the industry guidance that applies, when interacting with healthcare professionals in the context of marketing of prescription drugs in the USA. In addition, this module will be of benefit to regulatory affairs and legal personnel involved with aspects of marketing.
  
  

  Learning objectives
  

  • Identify the principal US legal statutes and regulations on interactions between drug companies and healthcare professionals (HCPs)
  • Identify Important sources of guidance from the Office of Inspector General (OIG) of the Department of Health and Human Services, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Food and Drug Administration (FDA)
  • Outline the provisions of the Anti-Kickback Statute, and access regulations on its ‘safe harbors’ provisions
  • Outline the provisions of the False Claims Act, including the use of qui tam ‘whistleblower’ lawsuits, and understand the risk of heavy penalties for violations
  • Comply with reporting requirements under the Physician Payments Sunshine Act
  • Comply with the requirements of the Prescription Drug Marketing Act and the Affordable Care Act as regards the provision of drug samples to HCPs
  • Follow guidance from the FDA on distribution of reprints and other publications to HCPs
  • Comply with limitations on detailing by sales representatives
  • Comply with legal requirements, and OIG, PhRMA and FDA guidance, on company speaker programs and third-party scientific and educational events
  • Outline the role of medical advisory boards and comply with PhRMA guidance on bona fide consulting services
  • Respond appropriately to unsolicited requests for off-label information

  
  
  Information and Guidance:

  • Advertising and Promotional Labeling Branch of the FDA’s Center for Biologics Evaluation and Research (CBER)
  • Anti-Kickback Statute
  • False Claims Act
  • FDA 21 CFR Part 202.1, US Code of Federal Regulations on prescription drug advertising
  • PhRMA Code – Pharmaceutical Research and Manufacturers of America Codes
  • REMS – Risk Evaluation and Mitigation Strategy
  • PHS Act – Public Health Service Act

  Outline:

  • Statutes and regulations
  • Regulatory and industry guidance
  • Anti-Kickback Statute
  • False Claims Act
  • Major settlements under FCA/AKS
  • Physician Payments Sunshine Act
  • Drug samples
  • Distribution of reprints and other publications
  • Detailing by sales representatives
  • Speaker programs
  • Third-party scientific and educational events
  • Medical advisory boards
  • Responding to unsolicited requests for off-label information
  • Gifts of educational or non-educational items
  • Assessment

  ---

  Drug Safety and Pharmacovigilance:

  (There is 9 course in this category)

  Introduction to Drug Safety and Pharmacovigilance

  
  Course ID: AV02
  Average Learning Time: 180 minutes
  CDP Credits: 2

  Master the essentials of drug safety monitoring and risk management – skills vital for medicinal product developers, license holders, and clinical investigators. Beyond fulfilling your duty to protect public health, understanding Good Pharmacovigilance Practice (GVP) can shield organizations from regulatory pitfalls and costly litigation. This engaging course offers an in-depth overview of drug safety before and after marketing, with a focus on Europe and the USA.

  • Learn core principles of pharmacovigilance
  • Understand regulatory expectations
  • Enhance compliance and protect patient safety

  Who will benefit from this module?
  
  Entry-level staff, and those seeking a refresher, in drug safety / pharmacovigilance and clinical departments will find the course invaluable, as will clinical investigators and other healthcare professionals. Staff in other departments of pharmaceutical and biotechnology companies will benefit from taking the course to gain an appreciation of the basics of the subject.
  
  

  Objectives
  
  

  • Explain, with examples, why drug safety monitoring / pharmacovigilance is necessary.
  
  
  • Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies.
  
  
  • Outline how drug safety / pharmacovigilance responsibilities are organized within pharmaceutical and biotechnology companies.
  
  
  • Sketch how a product safety database is compiled, how a product’s safety profile is assessed, and how safety information is included in documentation for regulatory authorities, healthcare professionals, and consumers.
  
  
  • Apply appropriate terms to describe different types of adverse effect.
  
  
  • Specify requirements to report adverse reactions to regulators.
  
  
  • Outline requirements for safety data and for risk management plans in applications for marketing approval.
  
  
  • List tasks involved in monitoring adverse reactions to marketed products, and sketch how safety signals are detected and tested.
  
  
  • Identify factors that influence the evaluation of a product’s benefit/risk balance, and list actions that may be taken in response to changes in the balance.
  
  
  Outline:
  Course overview – Describes what the course is about, sets out learning objectives, defines key terms and provides a brief overview of course content.
  
  

  Regulation and company organization – Explains the rationale for modern drug safety / pharmacovigilance (PV) regulation and practice, describes international policy-making bodies and sources of regulatory guidance, and outlines company drug safety / PV organization, product safety databases and core safety information.
  
  

  Before a product is marketed – Sets out the fundamentals of pre-marketing drug safety / PV: safety information for investigators, describing adverse effects, clinical trial reporting requirements, safety data in marketing applications, risk management planning, and product information.
  
  

  After a product is marketed – Sets out the fundamentals of post-marketing PV: monitoring adverse drug reactions, license holders’ reporting requirements, detecting and testing safety signals, assessing benefit/risk balance, risk minimization, communicating new safety information, product withdrawal.
  
  

  Quality system, inspections and audits – Describes measures, increasingly emphasized by regulators, to ensure adequate performance of a PV system: the organization’s PV quality system, regulatory inspections, and audits.
  
  

  Review and further information – Summaries key points and provides links to important guidance documents and other reference sources.
  
  

  Assessment – Multiple-choice mastery assessment.
  
  
  

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  Safety Reporting in Clinical Trials (Adverse Event Reporting)

  
  Course ID: CT13
  Average Learning Time: 120 minutes
  CDP Credits: 2

  Confidently navigate the complex regulatory landscape of adverse event reporting in clinical trials. This course breaks down responsibilities for investigators and sponsors, and clarifies key terminology and reporting requirements.

  • Differentiate between serious/non-serious and expected/unexpected events
  • Understand reporting timelines and processes
  • Apply controlled vocabularies for accurate coding

  Level: Introductory/intermediate
  
  Audience: Clinical research, drug safety and regulatory affairs staff, healthcare professionals
  
  Category: Clinical trials, drug safety, regulatory affairs
  
  Region: Europe, USA, other
  
  

  Who will benefit from this course?
  This course provides essential information for clinical research, investigational product safety, and regulatory affairs staff of sponsors of clinical trials, as well as investigators and other healthcare professionals who undertake clinical trials.
  
  

  Learning objectives

  • Identify sources of legal requirements, regulatory guidance, and other requirements for the conduct of clinical trials
  • Define reportable events and reactions in drug trials
  • Discuss criteria for causality, expectedness, and seriousness of events
  • Summarize investigators’ responsibilities for reporting to sponsors and research ethics committees
  • Specify requirements for expedited reporting by sponsors
  • Outline the role of data monitoring committees
  • Describe typical procedures for handling safety reports
  • Outline follow-up procedures and the content of case narratives
  • Describe trial monitoring activities related to safety reporting
  • Discuss the handling of reports concerning marketed products
  • Discuss the handling of reports of pregnancy and other special cases
  • Outline the management of blinding
  • Outline a typical timeframe for actions taken by a sponsor in response to reports of serious adverse events
  • Identify requirements for periodic aggregate reporting
  • Describe characteristics of the Medical Dictionary for Regulatory Activities
  • Specify the levels of the MedDRA hierarchy
  • Outline the use of MedDRA
  • Outline the ISO standards for the identification of medicinal products

  Outline:
  Adverse events and safety reporting
  In this session we explain the rationale for safety reporting in clinical trials, and we describe fundamental regulatory requirements. We discuss criteria for reporting, including causality, expectedness and seriousness. We set out the responsibilities of sponsors and investigators for individual-case expedited and aggregate reporting.
  
  
  Safety reporting by drug sponsors
  In this session we describe drug safety operations that will typically be carried out by a sponsor company or contract research organization engaged in clinical trials of medicinal products, and we outline some typical safety-reporting scenarios.
  
  
  Controlled vocabularies
  In this session we explain the requirement for the use of controlled vocabularies of medical terms in safety reporting. We describe the Medical Dictionary for Regulatory Activities (MedDRA) and identify the ISO standards for the identification of medicinal products (IDMP).
  
  
  Assessment
  Multiple-choice mastery assessment.

  ---

  Clinical Trial Safety Reporting Requirements in the EU and USA

  
  Course ID: CT14
  Average Learning Time: 120 minutes
  CDP Credits: 2

  Deepen your expertise in safety reporting by learning the legal and regulatory frameworks governing clinical trials in the EU and USA. This advanced course builds on CT13 and delivers jurisdiction-specific insights.

  • Compare EU and US regulatory expectations
  • Master timelines and documentation standards
  • Integrate global compliance strategies

  Level: Intermediate/advanced
  
  Audience: Clinical research, drug safety, and regulatory affairs staff, healthcare professionals
  
  Category: Clinical trials, drug safety, regulatory affairs
  
  Region: Europe, USA
  
  

  Who will benefit from this course?
  This course provides essential information for clinical research, drug safety, and regulatory affairs staff of sponsors of clinical trials, as well as investigators and other healthcare professionals who undertake clinical trials.
  
  

  Learning objectives

  • Identify relevant EU statutes and sources of regulatory guidance
  • Identify online portals that are key to safety reporting in clinical trials in the EU
  • Summarize investigators’ and sponsors’ responsibilities under the Clinical Trials Regulation
  • Discuss the role of reference safety information in the EU
  • Specify sponsors’ responsibilities for reporting suspected unexpected serious adverse reactions in the EU
  • Describe how to submit electronic reports to EudraVigilance
  • Outline sponsors’ responsibilities for reporting SUSARs to investigators under the Clinical Trials Regulation
  • Identify submissions that sponsors must make to the EU Clinical Trials Information System
  • Outline significant differences in requirements under the Clinical Trials Directive
  • Identify relevant US statutes and sources of regulatory guidance
  • Summarize clinical investigators’ responsibilities for reporting to sponsors of trials conducted under an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA)
  • Discuss the assessment of causality of serious adverse events
  • Summarize sponsors’ responsibilities for review of safety information under an IND
  • Specify sponsors’ responsibilities for IND safety reporting to FDA and investigators
  • Describe how to deal with anticipated events according to FDA guidance
  • Specify timeframes for IND safety reporting
  • Specify requirements for analysis of similar events and submission of follow-up information
  • Describe how to submit IND safety reports to the FDA
  • Discuss requirements for electronic submission of IND safety reports
  • Discuss requirements for investigators’ reporting of unanticipated problems to investigational review boards
  • Specify sponsors’ responsibilities for submission of IND annual reports

  Outline:
  Legal and regulatory requirements in the EU
  In this session, we set out the legal and regulatory requirements for safety reporting under the EU Clinical Trials Regulation. We specify the responsibilities of investigators and those of sponsors. We distinguish those reports that must be submitted by sponsors to the EudraVigilance portal and those that must be submitted to the Clinical Trials Information System. We specify the format and terminology that must now be used, and we identify the tools and pathways for electronic submission. Finally, we outline significant differences in requirements under the Clinical Trials Directive.
  
  
  Legal and regulatory requirements in the USA
  In this session, we set out the legal and regulatory requirements for safety reporting in clinical trials conducted (in the USA or elsewhere) under an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA). We specify the responsibilities of investigators and those of sponsors. We describe the criteria for IND safety reports to the FDA, and the content, format and timing of their submission. We discuss investigators’ obligation to report unanticipated problems to institutional review boards. Finally, we discuss IND annual reports and other safety reporting issues.

  Assessment
  Multiple-choice mastery assessment.

  ---

  Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration

  
  Course ID: PKPD01
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Gain a solid foundation in the science that connects drug development with patient outcomes. This course introduces you to PK/PD principles and their vital role in drug approval and clinical application.

  • Understand in-vivo PK/PD study designs
  • Interpret data for clinical and regulatory use
  • Enhance decision-making in drug development

  Who will benefit from this course?
  
  Pharmacologists, nonclinical researchers, clinical researchers, regulatory affairs staff, and others who contribute to drug development and registration will benefit from this module.
  
  

  Objectives
  
  

  • Describe the role of pharmacokinetics and pharmacodynamics in drug development and registration
  
  
  • Describe ways in which drug safety / pharmacovigilance is regulated nationally and internationally, and identify international policy-making bodies.
  
  
  • Identify the main types of pharmacokinetic and pharmacodynamic studies conducted during drug development, their goals, and the uses of the data obtained
  
  
  • Outline the pharmacokinetic characteristics of the various routes of drug administration
  
  
  • Discuss how in-vivo pharmacodynamic studies provide a bridge between science and medicine in drug development and registration
  
  

  Outline:
  Course overview – An outline of the module’s scope and objectives, and notes on terminology.
  
  

  Role of pharmacokinetics and pharmacodynamics – Although pharmacokinetic (PK) and pharmacodynamic (PD) studies are routinely carried out in nonclinical and clinical stages of drug development, their role is perhaps less well understood than it ought to be by those who are not specialists in the field. In addition, greater emphasis is being placed by regulators on the value of PK and PD data. Evidence of good practice in the execution of PK and PD studies, and sound understanding of the implications of their findings, are becoming increasingly important in drug registration. In this session we define PK and PD, outline the uses of PK and PD data in a drug development program, and give examples of how good practice in obtaining and interpreting PK and PD data can contribute to the minimization of risk for a drug.
  
  

  PK and PD studies in drug development – In this session we discuss the various types of study carried out to acquire pharmacokinetic and pharmacodynamic data, grouping them into those conducted in animals only, in animals and humans, and in humans only. We identify their goals, rationale, and place in a drug development program.
  
  

  Drug administration routes – In this session, after introducing the principal pharmacokinetic parameters, we describe the PK and PK/PD characteristics of each drug administration route. We discuss the different medical-scientific questions to be addressed by PK/PD research for the different routes.
  
  

  Pharmacodynamic studies – In this session we discuss the scope of pharmacodynamics, distinguish pharmacodynamic from clinical outcomes, and outline how the former may be used as surrogates for the latter. The core information from PD studies is a quantitative description of the dose-response relationship and the influence of various factors on this relationship. We emphasize the importance of interpreting the shape of the dose-response curve in making major decisions on a drug’s development. Finally, we discuss factors that can influence the beneficial and adverse effects of a drug.
  
  

  Assessment – Multiple-choice mastery assessment.
  
  
  

  ---

  Conducting Pharmacokinetic and Pharmacodynamic Studies

  
  Course ID: PKPD02
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Advance your PK/PD expertise with in-depth training on study design, sampling, data analysis, and research in special populations. This course builds directly on PKPD01, offering hands-on insights for real-world application.

  • Design effective PK/PD studies
  • Implement bioequivalence testing
  • Apply advanced analytical techniques

  Who will benefit from this course?
  
  Pharmacologists, nonclinical researchers, clinical researchers, regulatory affairs staff, and others who contribute to drug development and registration will benefit from this module.
  
  

  Objectives
  
  

  • Summarize the advantages, and how to counteract the main weakness, of the core design of choice for many pharmacokinetic and pharmacodynamic studies
  
  
  • Adopt good sampling practice
  
  
  • Discuss non-compartmental and compartmental data analysis
  
  
  • Describe the rationale and characteristics of studies in special populations
  
  
  • Describe how to carry out bioequivalence testing

  Outline:
  Course overview – An outline of the module’s scope and objectives, and notes on terminology.
  
  

  Study design – In this session we discuss the core design of choice for many PK and PD studies: crossover. We outline its advantages and how to counteract an important weakness, which is the carry-over effect.
  
  

  Sampling practice and outcomes – Arguably the most important aspect of the design of a PK or PD study is the sampling schedule. How many samples should be taken per subject and at which time points after dosing? Choice of these factors is crucial in minimizing bias and maximizing the precision of results. In this session we explain principles of good practice in sampling.
  
  

  Data analysis – In this session, after introducing the principal pharmacokinetic parameters, we describe the PK and PK/PD characteristics of each drug administration route. We discuss the different medical-scientific questions to be addressed by PK/PD research for the different routes.
  
  

  Special populations – Drug development entails research not only into the target population as a whole but into sub-populations with a common demographic or health characteristic that may produce treatment outcomes that differ significantly from the average. In this session we discuss such special populations and how they are studied.
  
  

  Generics and bioequivalence – Licensing of generic drugs is an area in which pharmacokinetic studies constitute the prime determining factor. In the great majority of cases the test that determines the licensing of a generic drug is a comparison of its plasma concentration-time course with that of the product it copies -a bioequivalence test- to assess whether they are sufficiently similar. In this session we describe how to carry out bioequivalence testing.
  
  

  Assessment – Multiple-choice mastery assessment.
  
  
  

  ---

  Drug Safety: Signal Detection and Management in Pharmacovigilance

  
  Course ID: PV04
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Discover how to identify, validate, and manage safety signals that protect patients and preserve your product’s benefit-risk profile. This course equips you with practical tools and methods – from medical assessments to advanced data mining – to ensure timely, accurate pharmacovigilance actions.

  • Master the four stages: detection, validation, analysis/prioritization, and risk minimization
  • Explore real-world and interventional study approaches
  • Gain skills to apply in regulatory and industry settings

  Who will benefit from this module?
  
  All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies or contract research organizations should have access to this course. It will also be of value to healthcare professionals and regulatory authority personnel.
  
  

  Objectives
  
  

  • Identify methods of signal detection and discuss their limitations
  
  
  • Describe how to accumulate evidence on a causal association between a drug and an event
  
  
  • Specify factors that increase the priority assigned to a signal, and describe methods of further investigation
  
  
  • Discuss reassessment of benefit/risk balance in the light of a previously unexpected reaction to a product, and specify actions to minimize risk
  
  Outline:
  Module overview – This session provides an outline of the course’s scope and objectives, and notes on terminology. It also defines safety signal and explains our approach to the signal detection and management process.
  
  

  Signal detection – The question addressed in this session is: ‘Are there data that may indicate a safety signal?’. The various sources of safety signal-relevant data are set out. ‘Traditional’ signal detection by qualitative review of individual case reports is described, followed by a discussion of quantitative analysis of aggregate data on drug-event associations to detect signals of disproportionate reporting, a process known as ‘data mining’.
  
  

  Signal validation – The question addressed in this session is: ‘Is there a safety signal?’. Steps taken to determine our degree of confidence in the existence of a signal are described. The development of a case series is outlined, and qualitative clues to causality are listed. Approaches to estimation of the incidence of the adverse event(s) in the exposed population are described: including crude approximation of reporting rate, and active surveillance through cohort/prescription-event monitoring and observational study in registries.
  
  

  Signal analysis and prioritization – The question addressed in this session is: ‘How important is the signal, and do we know enough about it?’. Factors that increase the priority assigned to a signal are listed. The consequences of assignment of a category of risk are outlined. Further investigation of a signal through controlled research, in the form of pharmacoepidemiological studies or clinical trials, is described, and factors influencing a decision to undertake such an investigation are set out.
  
  

  Risk assessment and minimization – The question addressed in this session is: ‘How does the signal affect benefit/risk balance, and what do we need to do about it?’. Factors affecting re-assessment of the benefit/risk profile of a product in the light of verification of a previously unexpected reaction are set out. Possible risk minimization actions are listed. Requirements for reporting to regulatory authorities are described, and advice is given on communicating safety information to healthcare professionals and consumers.
  
  

  Assessment – Multiple-choice mastery assessment.
  
  
  

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  Drug Safety: Risk Management Planning for Medicinal Products

  
  Course ID: PV05
  Average Learning Time: 90 minutes
  CDP Credits: 1.25

  Elevate your pharmacovigilance practice by mastering proactive risk management planning. This course delivers a step-by-step guide to developing compliant, effective risk management plans for global markets.

  • Understand CIOMS IX, ICH E2E, and GVP Module V principles
  • Navigate EU and FDA regulatory requirements
  • Design risk plans that align with best practices

  Who will benefit from this module?
  
  All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies or contract research organizations should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.
  
  

  Objectives
  
  

  • Explain important principles of risk management planning
  
  
  • Give examples of risk minimization activities
  
  
  • Describe the selection of risk minimization activities that are proportional to a product’s benefit/risk balance and do not impose undue burden on stakeholders
  
  
  • Outline regulatory requirements for risk management plans in regions that are major markets for medicinal products
  
  Outline:
  Course overview – An outline of the course’s scope and objectives, and notes on terminology.
  
  

  Principles of risk management planning – In this session we set out principles of risk management planning as a major component of good pharmacovigilance practice. We discuss the modern emphasis on proactive risk management in addition to routine pharmacovigilance measures. We describe risk assessment factors important in safety specification, pharmacovigilance planning, and risk minimization for a drug. We then focus on the selection, implementation, and evaluation of non-routine risk minimization activities.
  
  

  Regulatory requirements for risk management plans – In this session we outline regulatory requirements for risk management plans in regions that are major markets for medicinal products: Europe, the USA, and (in a brief sketch) Japan. We describe the structure, main components, and submission requirements for EU Risk Management Plans and US Risk Evaluation and Mitigation Strategies, and we sketch notable aspects of risk management requirements in Japan.
  
  

  Assessment – Multiple-choice mastery assessment.
  

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  Drug Safety: Urgent Safety Restrictions

  
  Course ID: PV06
  Average Learning Time: 45 minutes
  CDP Credits: 0.75

  Learn to respond decisively when safety signals demand urgent regulatory action. This course demystifies Urgent Safety Restrictions (USRs) in Europe, preparing you to act swiftly and effectively.

  • Understand USR procedures and regulatory expectations
  • Master the 24-hour execution process
  • Prepare accurate variation applications under pressure

  Who will benefit from this module?
  
  All staff working in medical, drug safety, or pharmacovigilance departments of pharmaceutical or biotechnology companies with products authorized in Europe should have access to this module. It will also be of value to healthcare professionals and regulatory authority personnel.
  
  

  Objectives
  
  

  • Explain the purpose of Urgent Safety Restrictions in Europe
  
  
  • Describe how an USR may be triggered
  
  
  • Describe the general regulatory requirements for preparation and initiation of an USR
  
  
  • Outline the 24-hour procedure for execution of an USR
  
  
  • Specify the requirements for a variation application following an USR
  
  
  
  Outline:
  Overview – An outline of the course’s objectives, and notes on terminology.
  
  

  Principles – In this session we define Urgent Safety Restriction and explain its purpose in the European Union and other countries of the European Economic Area. We describe how an USR may be triggered. Finally, we give some examples of safety signals that may, and some that may not, give rise to an USR.
  
  

  Procedure – In this session we describe how to prepare for and initiate an Urgent Safety Restriction (USR) for a centrally authorized product and for a product authorized through the Mutual Recognition or Decentralized Procedure. We outline the 24-hour procedure for execution of an USR, and the follow-up actions required, in each case. Finally, we specify the requirements for a variation application following an USR.
  
  

  Assessment – Multiple-choice mastery assessment.
  
  
  

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  Drug Safety: Good Pharmacoepidemiology Practice

  
  Course ID: PV07
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Bridge the gap between clinical pharmacology and epidemiology to deliver high-impact, real-world evidence. This course is designed for professionals conducting and analyzing pharmacoepidemiological research while adhering to best practices.

  • Plan and conduct robust population-based studies
  • Generate evidence supporting product safety and effectiveness
  • Apply findings to enhance patient outcomes

  Who will benefit from this module?
  
  Staff working in drug safety and pharmacovigilance or clinical research departments of pharmaceutical and biotechnology companies will benefit from this module. It will also be of value to healthcare professionals.
  
  

  Learning objectives
  
  On completion of this module, you should be able to follow good practice in:
  
  –Planning pharmacoepidemiological research
  
  –Collecting data in such research
  
  –Analyzing data from pharmacoepidemiological studies
  
  –Interpreting and communicating the results of such studies
  
  Outline:
  Study planning and data collection
  
  –Outline the role and formulation of a research question and study protocol
  
  –Discuss the choice of study design and research methods
  
  –Identify types of data source and means of data collection
  
  –Summaries obligations for protection of subjects
  
  –Discuss operational definition and validation of drug exposure, outcomes, and covariates
  
  –Give examples of good practice in data collection, management, and verification
  
  
  Analysis, interpretation, and communication
  
  –Discuss data analysis and the interpretation of results
  
  –Outline the role and formulation of a statistical analysis plan
  
  –Describe obligations for provision of a study report and communication of findings
  
  
  Assessment- Multiple-choice mastery assessment.
  

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  Good Manufacturing Practice (cGMP):

  (There are 0 courses in this category)

  Electronic Records & Signatures:

  (There are 3 courses in this category)

  Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)

  
  Course ID: ESR01A
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Unlock the skills to ensure your electronic records and signatures meet the FDA’s gold standard for trust and reliability. This course equips you with the knowledge to comply with 21 CFR Part 11-the regulation that governs electronic documentation in FDA-regulated industries.

  What You’ll Learn:

  • Core requirements of 21 CFR Part 11 for computer systems
  • How to establish compliant controls and procedures
  • Application of Part 11 across GxP environments
  • How to ensure your records are as reliable as paper originals
  • Compliance for both U.S.-based and international companies

  Who will benefit from this module?
  This module provides essential training for all personnel who use computer systems in GxP environments.
  
  

  Learning objectives:

  • Define regulation 21CFR11 and explain its context and purpose
  • Specify criteria to determine which environments, computer systems, electronic records, and electronic signatures must comply with the regulation
  • Describe procedures and controls required by the regulation for electronic records and electronic signatures
  • Describe the consequences of the FDA’s discretion in enforcing compliance with some of the provisions of the regulation

  Outline:
  Course Overview– An outline of the course scope and objectives, and notes on terminology.
  
  

  21 CFR Part 11 and its scope– We define regulation 21 CFR Part 11, explain its purpose, and set out criteria for identifying the environments, computer systems, electronic records, and electronic signatures to which it applies. We describe how underlying legal requirements are specified by predicate rules. We point out that it is not the type of computer system that determines whether Part 11 applies, but the use to which the system is put. Finally, we introduce the regulation’s distinction between closed and open systems.
  
  

  Procedures and controls– We describe the procedures and controls that need to be established and followed to comply with Part 11. We identify those for which the FDA exercises enforcement discretion. We give examples of open systems and outline additional procedures and controls required for them.
  
  

  Electronic signatures– We set out Part 11’s requirements for electronic signatures. We specify the information to be provided and we outline constraints on the way signatures are linked to records. We emphasize the importance of uniqueness of signatures and verification of the identity of signatories. We mention the need for one-off certification with the FDA. We outline components of non-biometric and biometric signatures. Finally, we set out procedures and controls required for user names and passwords.
  
  

  FDA enforcement discretion– We describe the FDA’s narrow interpretation of Part 11, and its effect on the need to comply with some of the regulation’s provisions. We discuss the latest relevant FDA guidance for industry and the effect of the agency’s interpretation on its enforcement of compliance with requirements for validation, audit trails, record retention, and record copying. We also specify the exemption for legacy computer systems.
  
  

  Assessment– Multiple-choice mastery assessment.

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  Assuring Data Integrity in the Manufacture of Medicinal Products

  
  Course ID: ICT02
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Learn how to safeguard your manufacturing data and meet the strict expectations of global regulators. This course covers the principles, requirements, and best practices for maintaining data integrity throughout the pharmaceutical manufacturing process.

  • Understand regulatory inspection focus on data integrity
  • Identify common data integrity pitfalls and how to avoid them
  • Implement practices to ensure trust in your manufacturing data
  • Meet expectations in nonclinical, clinical, manufacturing, and distribution environments

  
  Includes training on FDA’s 21 CFR Part 11 and European Union’s (EU) Good Manufacturing Practice (GMP) Annex 11: Computerized Systems.Who will benefit from this module?
  
  This module provides essential learning for all personnel who work in a medicinal products manufacturing environment.
  
  
  Learning objectives
  
  – Define fundamental concepts of data integrity and outline how they are applied in manufacturing
  
  – Identify failures of data integrity that may be found by regulatory inspectors, and the unacceptable practices that give rise to them
  
  – Comply with legal requirements and regulatory expectations concerning paper-based data
  
  – Comply with legal requirements and regulatory expectations concerning electronic data
  
  
  Level: Introductory
  
  Audience: Medicinal products manufacturing personnel and management
  
  Categories: Information and communication technology; Good Manufacturing Practice; Good practices for regulated laboratories
  
  Region: Europe, USA, other
  
  Includes training on FDA’s 21 CFR Part 11 and European Union’s (EU) Good Manufacturing Practice (GMP) Annex 11: Computerized Systems.
  Outline:
  Data integrity definitions and fundamentals
  What do we mean by data; What is data integrity; ALCOA and ALCOA+; Raw data and metadata; Transcription and transformation of data; Static and dynamic data; True copies; Archiving and retention; Validation of computerized systems; Data governance; Key questions to answer; Unacceptable practices; Regulators; and responses to data integrity failings.

  Integrity of paper-based data
  Control of paper-based data; Recording data on paper; Making handwritten corrections; Verification of records (secondary review); Signatures and delegation; Storage, archiving and retention of paper records.

  Integrity of electronic data
  Restrictions on access to computerized systems; Data entry/capture; Audit trails; Review of data; Protection of data; Storage, backup and archiving; Data transfer and migration; Electronic signatures; Reporting, investigation and correction of data integrity issues; Outsourced activities.

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  Assuring Data Integrity in Clinical Research

  
  Course ID: ICT03
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Protect your clinical trial credibility by ensuring data is complete, consistent, and accurate. This course details how trial sponsors, investigators, and research staff can meet data integrity requirements and avoid costly regulatory actions.

  • Understand regulatory data integrity expectations in clinical research
  • Apply principles to protect data accuracy and authenticity
  • Prepare for inspections and regulatory reviews
  • Learn from real-world examples of data integrity failures

  
  Includes training on FDA’s 21 CFR Part 11 and European Union’s (EU) Good Manufacturing Practice (GMP) Annex 11: Computerized Systems.Who will benefit from this module?
  
  This module provides essential learning for all healthcare professionals participating in clinical research, and all clinical development staff of medicinal products and medical device manufacturers
  
  
  Learning objectives
  
  – Describe basic principles of data integrity assurance
  
  – Comply with regulatory requirements and good practices for the assurance of paper-based data in clinical research
  
  – Comply with regulatory requirements and good practices for the assurance of electronic data in clinical research
  
  
  Level: Introductory
  
  Audience: Healthcare professionals participating in clinical research; clinical development staff of medicinal products and medical device manufacturers
  
  Categories: Information and communication technology; Clinical trials; Medical devices; Good practices for regulated laboratories
  
  Region: Europe, USA, other
  
  Includes training on FDA’s 21 CFR Part 11 and European Union’s (EU) Good Manufacturing Practice (GMP) Annex 11: Computerized Systems.
  Outline:
  Data integrity definitions and fundamentals
  What do we mean by data; What is data integrity; ALCOA, ALCOA+ and ALCOA++; Source data and metadata; Transcription and transformation of data; Static and dynamic data; Certified copies; Archiving and retention; Validation of computerized systems; Data governance; Safeguarding of blinding; Regulators; and responses to data integrity failings.

  Integrity of paper-based data
  Document control; Recording data by hand; Correcting handwritten data; Submitting paper CRFs to sponsor; Storage, archiving and retention of paper records.

  Integrity of electronic data
  Electronic source data and originators; Entry of data to an eCRF; Calibration of instruments; Remote data acquisition; Restrictions on access to computerized systems; Manual data entry; Verification of data; Audit trails and other metadata; Modifications and corrections; Review and sign-off of data; Protection of data; Storage, backup and archiving; Data transfer and migration; Electronic signatures.

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  Validation:

  (There are 7 courses in this category)

  Validation: Introduction to Validation

  
  Course ID: VAL01
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Step into the world of validation-a cornerstone of quality in the medicines and healthcare products industries. This course introduces you to the essential principles, regulations, and best practices that ensure equipment, services, systems, and processes consistently deliver products that meet the highest quality standards.

  What You’ll Learn:

  • Why validation is vital for regulatory compliance and product quality
  • The role of documented evidence in meeting predetermined standards
  • Key regulations and guidance shaping validation requirements
  • How a typical pharmaceutical validation team works in practice

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives
  

  • Define terms relating to validation
  • Access sources of regulations and guidance on validation in the medicines and healthcare products industries
  • Specify the phases of equipment qualification and process validation and describe the goals of each phase
  • Use risk assessment to determine the scope of a validation project
  • Describe the relationships between specifications and protocols in the V model of validation
  • Discuss criteria for User Requirements Specification, Factory Acceptance Testing, and Site Acceptance Testing
  • Identify important documents created and used during a validation project, and specify their relationships
  • Describe procedures for change control of validation documentation

  
  Outline:
  Module outline
  Regulations, guidance and definitions
  This session emphasizes the need to comply with regulatory requirements and guidance on validation, identifying important regulatory authorities and international collaborations. It identifies the phases of equipment qualification, describes the purpose of process validation in relation to process control, and defines important terms relevant to validation.

  Development of risk-based approach to validation
  This session explains why, in the absence of process validation, testing of samples is inadequate to provide assurance of product quality, safety and effectiveness. It outlines the historical development of validation requirements and identifies some current trends. It emphasizes the importance of a risk-based approach to validation and describes factors for assessing risk.

  What to validate?
  This session explains how to develop the scope of a validation plan, distinguishing critical and non-critical equipment, services and utilities. It specifies criteria for validation of computerized systems and for selection of process steps for validation. Finally, it discusses the importance of validation of cleaning and laboratory test methods.

  Stages of validation
  This session describes the ‘V model’ approach to equipment qualification. It outlines the contents of a User Requirements Specification document, and explains the role of Factory Acceptance Testing and Site Acceptance Testing. It distinguishes commissioning and qualification, and describes the phases of qualification and validation. Finally, it identifies standard operating procedures that are created during qualification and validation.

  Documentation and change control
  This session identifies important documents created during a validation project, and outlines relationships among protocols and reports. It describes how to record deviations and failures, and their resolution. Finally, it discusses requirements for change control of validation documentation.

  Assessment
  The assessment tests the learner’s assimilation of the module’s content.

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  Validation: Plans and Documentation

  
  Course ID: VAL02
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  In validation, documentation is your proof of compliance and quality. This course dives into the critical role of planning and documentation in ensuring manufacturing processes consistently produce safe, effective products.

  Course Highlights:

  • Understanding Validation Master Plans (VMPs) and project validation plans
  • Creating and using essential validation documents
  • Aligning plans with industry regulations and quality standards
  • Real-world examples from pharmaceutical validation teams

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives

  • Describe the purpose and scope of validation master plans, outline their typical structure and contents, and explain their importance to management
  • Contribute to the creation of project validation plans and protocols
  • Identify important validation documents, specify their interrelationships, and describe how they are created and maintained
  • Prepare and use validation schedules and resource plans, explain the basics of change control, and outline regulatory requirements for reporting and validating manufacturing changes

  Outline:
  Validation master plan
  This session describes the purpose and scope of validation master plans. It outlines the structure and contents of a typical validation master plan.

  Project validation plan
  This session describes how to use risk assessment to establish the scope of a project validation plan. It distinguishes prospective validation, continuous process verification, and concurrent validation. It identifies equipment and services that typically require qualification.

  Validation documentation
  This session identifies important validation documents and specifies their interrelationships. It outlines responsibilities and systems for control and approval of documentation in a validation project. It explains how to contribute to the development of validation protocols. It outlines how deviations and failures are dealt with, and the handling of raw data and reports. Finally, it describes procedures for tracking, cataloguing and archiving validation documents.

  Scheduling, resource planning and change control
  This session describes the purpose and use of validation schedules and validation resource plans. It discusses revalidation requirements in change management, and outlines requirements for reporting manufacturing changes to regulators.

  Assessment
  The assessment tests the learner’s assimilation of the programs content.
  

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  Validation: Commissioning and Installation Qualification (IQ)

  
  Course ID: VAL03
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Before any equipment can begin routine production, it must undergo rigorous commissioning and Installation Qualification (IQ). This course takes you step-by-step through the international principles and regulatory expectations that govern IQ in the healthcare and pharmaceutical sectors.

  You Will Discover:

  • The differences between commissioning and IQ
  • Regulatory requirements for installation qualification
  • Procedures and best practices for implementing IQ
  • Case study: A validation team commissioning a new system

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives

  • Define commissioning and Installation Qualification activities and scope
  • Explain the purposes of, and differences between, commissioning and qualification
  • Determine qualification requirements based on an impact assessment
  • Prepare and execute IQ protocols
  • Describe requirements for the content and approval of IQ reports

  Outline:
  Introduction
  A brief introduction to the validation project that provides a case study on validation.

  Basics of commissioning and Installation Qualification
  This session defines commissioning and Installation Qualification (IQ), summarizes their purposes, and identifies differences between them. It outlines the progression of commissioning and IQ in a validation project, along with the roles of Factory Acceptance Testing and Site Acceptance Testing. It describes how responsibilities for commissioning and IQ are assigned in a typical company. It identifies vendor equipment documentation that may be included in specifications, as well as the contents of commissioning reports.

  Impact assessment
  This session explains the roles of impact assessment and criticality assessment. It discusses how to draw system boundaries and use impact assessment to determine the scope of qualification work required.

  Installation Qualification
  This session describes how to decide which components of each system require qualification and which need only be commissioned. It identifies systems/services that support the production line, and gives examples of tests applied to them as part of qualification. It identifies important parts of IQ protocols, and gives examples of qualification criteria specified in protocol test sheets. Finally, it outlines requirements for calibration of devices, instruments and systems.

  IQ documentation
  This session specifies important characteristics of IQ protocols, and outlines how to execute the protocols. It identifies documents that typically need to be completed during qualification. It specifies contents of an IQ report, and identifies requirements for the sign-off of protocols and reports.

  Assessment
  The assessment tests the learner’s assimilation of the module’s content.

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  Validation: Operational and Performance Qualification (OQ/PQ)

  
  Course ID: VAL04
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Once equipment has passed IQ, it must prove it can perform to exact specifications- every time. This course introduces Operational Qualification (OQ) and Performance Qualification (PQ) requirements, processes, and real-world applications.

  Training Objectives:

  • Differentiate between OQ and PQ- and when each applies
  • Prepare, approve, and execute OQ/PQ protocols
  • Compile OQ and PQ reports that meet regulatory standards
  • Understand the scope, activities, and responsibilities of OQ/PQ

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives

  • Define OQ and PQ
  • Explain the scope of OQ and PQ
  • Identify typical responsibilities of company staff for OQ and PQ
  • Specify the steps of OQ and PQ and describe activities to be carried out
  • Prepare, approve and execute OQ and PQ protocols
  • Write OQ and PQ reports

  Outline:
  Introduction
  A brief introduction to the validation project that provides a case study on validation.

  Operational Qualification
  This session explains how to identify equipment, systems and services to which Operational Qualification (OQ) applies. It identifies typical responsibilities of company staff and vendors for OQ. It specifies prerequisites for OQ and describes steps in the OQ process. It identifies tests required of equipment, systems and services during OQ. The learner is shown how to develop, review and execute protocols that specify the tests required, and to write OQ reports.

  Performance Qualification
  This session specifies the purpose of Performance Qualification (PQ), and identifies typical responsibilities of company staff for PQ. It specifies the steps of PQ and describes the activities to be carried out, including environmental microbial monitoring where necessary. The learner is shown how to prepare, review and execute PQ protocols and write PQ reports.

  Assessment
  The assessment tests the learner’s assimilation of the module’s content.

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  Validation: Equipment Cleaning Validation

  
  Course ID: VAL08
  Average Learning Time: 90 minutes
  CDP Credits: 1.5

  Validated cleaning procedures are essential to ensuring product purity and patient safety. This course covers everything you need to know about developing, executing, and documenting an equipment cleaning validation program that meets global regulatory requirements.

  Key Takeaways:

  • Regulatory expectations for cleaning validation
  • Defining cleaning validation prerequisites and scope
  • Developing and executing cleaning validation protocols
  • Setting cleanliness criteria and analyzing validation results
  • Understanding key terminology in cleaning validation

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of cleaning validation, as set out in this module. In particular, the module provides essential learning for engineering, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives

  • Define cleaning validation terminology, and explain regulatory requirements
  • Determine the scope of cleaning validation
  • Carry out and validate tests of cleanliness
  • Determine acceptance criteria
  • Develop and execute a cleaning validation protocol
  • Analyze and report cleaning validation results, and outline an ongoing cleaning and monitoring program

  Outline:
  Introduction
  An introduction to the validation project that provides a case study on validation, plus definitions and a glossary.

  Scope of cleaning validation
  This session compares and contrasts different approaches to equipment cleaning validation: equipment-train vs individual item; common vs dedicated equipment; batch-to-batch vs product-to-product cleaning; automated vs manual. It identifies requirements that cleaning SOPs need to meet. It explains the bracketing of products for cleaning validation. It outlines the qualification of clean-in-place systems, and the use of previous cleaning validation data. Finally, it describes techniques for testing surface residues.

  Validation of test methods
  This session identifies analytical techniques that are appropriate for cleaning validation studies. It defines limit of detection (LOD) and limit of quantitation (LOQ). Finally, it explains how to carry out swab recovery studies.

  Acceptance criteria
  This session identifies factors to be considered when determining acceptance limits for product carryover. It explains how to use toxicity and solubility data in determining acceptance criteria. It describes the selection of worst-case, follow-on, and representative products for cleaning validation studies. It explains how to calculate Maximum Allowable Carryover (MAC), and Surface Area Limit (SAL) for swab testing.

  Writing and executing protocols and writing reports
  This session identifies essential elements of a cleaning validation protocol. It describes how to specify worst-case conditions for cleaning validation, and sampling at the most difficult-to-clean locations. It explains why a cleaning validation protocol is usually applied to actual batch manufacture. It provides checklists for preparedness to execute a cleaning validation protocol, and for the documentation of results. It summarizes the content of a cleaning validation report. Finally, it outlines ongoing cleaning requirements after validation.

  Assessment
  The assessment tests the learner’s assimilation of the module’s content.

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  Validation: Computer System Validation (Part 1 of 2) (Planning)

  
  Course ID: VAL09
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Computerized systems in GMP-regulated environments must be validated to ensure reliability and compliance. This course focuses on the planning phase of Computer System Validation (CSV), guiding you through FDA requirements, risk assessment, and supplier evaluation.

  Learning Outcomes:

  • Understand the computer system life-cycle and CSV fundamentals
  • Develop effective validation strategies and plans
  • Apply GAMP®5 principles to system validation
  • Assess and qualify software suppliers
  • Address FDA rules on electronic records and signatures

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of computerized system validation, as set out in this module. In particular, the module provides essential learning for engineering, information and communication technology, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives

  • Define computer systems validation
  • Outline criteria for selecting systems to be validated and for initial estimation of the degree of validation required
  • Access important guidance documents by industry bodies and regulatory authorities
  • Identify the phases of the computer systems lifecycle and describe the activities that are performed in each phase
  • Describe considerations influencing validation strategy
  • Describe the principles of GAMP®5, risk assessment, and risk management.
  • Assess software suppliers and their products
  • Outline the contents of a validation plan

  Outline:
  Introduction
  This session defines computer system validation and specifies its benefits. It identifies, in general terms, which systems need to be validated. It identifies sources of guidance from industry bodies and regulatory authorities, and it discusses the importance of protection of data integrity.

  The planning phase
  This session identifies the phases of the computer systems lifecycle, and outlines the activities that are performed in the planning phase. It specifies the purposes of a User Requirements Specification and a traceability matrix.

  Validation strategy and plan
  This session specifies criteria for regulatory assessment. It outlines FDA requirements on electronic records and electronic signatures. It describes in detail how to assess software suppliers and their products. It sets out principles of GAMP®5, risk assessment, and risk management. Finally, it outlines the contents of a validation plan, including change management.

  Assessment
  The assessment tests the learner’s assimilation of the module’s content.

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  Validation: Computer System Validation (Part 2 of 2) (Implementation)

  
  Course ID: VAL10
  Average Learning Time: 60 minutes
  CDP Credits: 1

  Building on VAL09, this course takes you through the design, development, installation, validation, and maintenance phases of CSV. You’ll also learn how to handle legacy systems and perform retrospective validation.

  Course Benefits:

  • Learn each phase of the computer system life-cycle
  • Understand strategies for determining validation scope
  • Perform retrospective validation on legacy systems
  • Pass a final assessment to receive your official certificate

  Who will benefit from this module?
  Manufacturing personnel in the pharma/biotech, dietary supplement, and medical devices industries need to understand the principles and practice of computer systems validation, as set out in this module. In particular, the module provides essential learning for engineering, information and communication technology, production, and quality management personnel in the pharmaceutical industry.

  Learning objectives

  • Describe the design, development and installation phase of projects to validate computerized systems
  • Describe the validation phase of such projects
  • Describe the operation and maintenance phase
  • Determine which systems to validate
  • Determine the amount of validation required, and the strategy to use

  Outline:
  Design, development and installation phase
  This session specifies the roles of functional and design specifications. It outlines the development testing process, and describes the formulation and use of test plans, cases and scripts. It identifies characteristics of good testing practices, and emphasizes the importance of development change management.

  Validation phase
  This session specifies the activities to be performed in the validation phase, and outlines their timing. It states the purposes of platform qualification, application installation qualification, operational qualification, and performance qualification. It specifies tests typically carried out in operational qualification and performance qualification. Finally, it describes the roles of validation change management and the validation report.

  Operation and maintenance phase
  This session describes the measures that need to be in place during the operation and maintenance phase. It outlines the management of the decommissioning of a system. It identifies changes that need to be controlled in the operation and maintenance phase.

  Assessment
  The assessment tests the learner’s assimilation of the module’s content.

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