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

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format (PRA03)

Certification Training
 
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Method of Training: Online / Self-paced eLearning.
Credits: 1.5 CPD Credits.
Duration: ~1.5 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Pharmaceutical Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

The CTD is the internationally recognized standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European Economic Area, required for prescription drugs in Japan and elsewhere, and accepted by a growing number of other national regulators. Use of the electronic version of the CTD is mandatory for applications for marketing approval and all subsequent submissions in the USA. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

This course discusses the regulatory approval of the Common Technical Document, the use of the Common Technical Document and its structure, and the conversion of other formats to Common Technical Document.

A passing grade of 75% or more is required. Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed in order to achieve a passing grade.

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Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE 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.

COURSE OBJECTIVES:


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.

The Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format Course is Included in the Following Professional Certification Programs:


International Pharmaceutical Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ ... Learn more

US Pharmaceutical Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Comm ... Learn more

Full List of Programs in the Pharmaceutical Regulatory Affairs Catalog:



US Pharmaceutical Regulatory Affairs Professional Certification Program: This online professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the 'NDA Process'. The program describes preparing submissions using the Comm ... Learn more

International Pharmaceutical Regulatory Affairs Professional Certification Program: This professional certification program includes descriptions of the decentralized procedure (DCP), EU variations procedure, the mutual recognition procedure (MRP), the European centralized procedure (CP); requ ... Learn more

Regulatory Affairs: Essentials for Human Medicinal Products - EU and US: This foundation-level training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to mai ... Learn more

Regulatory Affairs: Orphan Drug Application - EU and US: Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as 'orphan drugs' because they are commercially unattractive. Development of such products is successfully encouraged thr ... Learn more

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Format: The CTD is the internationally recognized standard format for submissions to medicines regulatory authorities. Its use is mandatory for all applications in the European Economic Area, required for prescription ... Learn more

Regulatory Affairs: Electronic Common Technical Document (eCTD): The eCTD specification has been developed to facilitate the global electronic submission, review and lifecycle management of medicinal product dossiers for regulatory applications. It broadens the scope of the ... Learn more

Regulatory Affairs: How to Gain Approval to Market Generic Drugs in the US: This course outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. Th ... Learn more

Regulatory Affairs: Submitting a New Drug Application (NDA) to Obtain Approval to Market in the US: An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful approval, what format and content ... Learn more

Regulatory Affairs: The European Centralized Procedure (CP): This online course describes the procedure's various players, the duration and sequence of the stages involved, and requirements on timing, format, and content of submissions. In the Centralized Procedure, one ... Learn more

Regulatory Affairs: The Mutual Recognition Procedure (MRP): The Mutual Recognition Procedure is one of three routes available to applicants to gain multinational Marketing Authorization within the European Economic Area (EEA) on the basis of a single application. A nati ... Learn more

Regulatory Affairs: Variations to Marketing Authorizations in Europe: Changes to the terms of marketing authorizations for medicinal products, called variations in Europe, must be notified to or approved by the relevant regulatory authorities. Variations include changes to the co ... Learn more

Regulatory Affairs: The Decentralised Procedure (DCP): The DCP is one of three routes available to applicants to gain multinational marketing authorization within the European Economic Area (EEA) on the basis of a single application. It can be used only for a produ ... Learn more

Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies: This course addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biologica ... Learn more

Regulatory Affairs: The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA: The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than ... Learn more

Regulatory Affairs: Essentials of Monoclonal Antibodies: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, ... Learn more

Regulatory Affairs for Monoclonal Antibodies Professional Certification Program: Monoclonal antibodies (mAbs for short) are the leading products of biotechnology. Drugs based on mAbs dominate the list of top-selling medicines worldwide. In addition, mAbs have many uses in medical diagnosis, ... Learn more

Online Training: The Benefits of eLearning

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