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Use this form to search course ID, name, description, outline, and objectives. This is a multiple word search. Each word must be 3 characters or more (e.g., GMP, GCP, Clinical, etc). Shorter words and any special characters (e.g., PQ, OQ, PQ/OQ, /, \, (, ), etc.) will be ignored. You can search courses for things such as GMP001S1, GAMP, Pharmacovigilance, Quality Assurance, ALCOA, Validation, Clinical Trials, CFR Part 820, Cleaning Validation, or Drug Safety.

  


Searching courses for: Clinical Trials


(47 Programs Found)

Certification Training Clinical Trials:  How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

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

To conduct a clinical trial in one or more member states (MSs) of the European Economic Area (EEA) a sponsor must first gain the approval of each relevant national regulator and the favourable opinion …
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Course ID: CT11
Average Learning Time: 120 minutes
Price: $225 | Enroll Now >>
Certification Training Clinical Trials Management Professional Certification Program (US & EU)
Professional Certification Program:

Clinical Trials Management Professional Certification Program (US & EU)

The Clinical Trials Management (US & EU) Professional Certification Program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. I …
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Course ID: GCP00A1
Average Learning Time: See Program Webpage
Price: $1295 | Enroll Now >>
Certification Training Clinical Trial Safety Reporting Requirements in the EU and USA
Individual Course w/Certificate of Completion:

Clinical Trial Safety Reporting Requirements in the EU and USA

This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the fou …
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Course ID: CT14
Average Learning Time: 120 minutes
Price: $225 | Enroll Now >>
Certification Training Clinical Trials: How to Conduct Clinical Research Under the EU Clinical Trials Regulation
Individual Course w/Certificate of Completion:

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

The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the European Economic Ar …
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Course ID: CT12
Average Learning Time: 60 minutes
Price: $175 | Enroll Now >>
Certification Training Clinical Trials: Preparation and Design
Individual Course w/Certificate of Completion:

Clinical Trials: Preparation and Design

Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical tria …
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Course ID: GCP002
Average Learning Time: 240 minutes
Price: $225 | Enroll Now >>
Certification Training Clinical Trials Monitor - Professional Certification Program for CRAs
Professional Certification Program:

Clinical Trials Monitor – Professional Certification Program for CRAs

GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensur …
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Course ID: GCP00A
Average Learning Time: See Program Webpage
Price: $845 | Enroll Now >>
Certification Training Clinical Trials:  How to Obtain Approval to Conduct Clinical Trials in the EU
Individual Course w/Certificate of Completion:

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

To conduct a clinical trial in the European Economic Area the sponsor must apply for authorization from the national competent authority (i.e. medicines regulator), and favorable opinion must be obtai …
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Course ID: GCP020
Average Learning Time: 180 minutes
Price: $175 | Enroll Now >>
Certification Training Clinical Trials Coordinator Professional Certification Program for CRCs
Professional Certification Program:

Clinical Trials Coordinator Professional Certification Program for CRCs

The Clinical Trials Coordinator Professional Certification Program for CRCs provides a strong foundational understanding of clinical trails and all stakeholder responsibilities, with strong emphasis o …
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Course ID: CRCPRO
Average Learning Time: See Program Webpage
Price: $995 | Enroll Now >>
Certification Training Clinical Trials and Drug Development
Individual Course w/Certificate of Completion:

Clinical Trials and Drug Development

This course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined. …
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Course ID: GCP003
Average Learning Time: 90 minutes
Price: $175 | Enroll Now >>
Certification Training The General Data Protection Regulation (GDPR) and Clinical Trials
Individual Course w/Certificate of Completion:

The General Data Protection Regulation (GDPR) and Clinical Trials

The General Data Protection Regulation (GDPR) and Clinical Trials course covers how to exchange personal data during and after study conduct while following the GDPR requirements for data protection.

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Course ID: CP009a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)
Individual Course w/Certificate of Completion:

Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)

From the EU Clinical Trials Directive to the Clinical Trials Regulation, the content includes an overview of the requirements for the conduct of clinical trials in the European Union, the EU Regulatio …
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Course ID: CP018a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals
Training Program For Professionals:

Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals

The Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals program is designed for regulatory affairs specialists, managers, directors, and project managers. The program may al …
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Course ID: GCP00A2
Average Learning Time: See Program Webpage
Price: $895 | Enroll Now >>
Certification Training EU-MDR - Chapter VI - Clinical Evaluation and Clinical Investigations
Individual Course w/Certificate of Completion:

EU-MDR – Chapter VI – Clinical Evaluation and Clinical Investigations

This is a significant and exciting chapter introducing a life-cycle approach to ongoing CE Marking compliance; it is a process, not a project. One output of the clinical evaluation process is demonstr …
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Course ID: ELM-322
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Safety Reporting in Clinical Trials (Adverse Event Reporting)
Individual Course w/Certificate of Completion:

Safety Reporting in Clinical Trials (Adverse Event Reporting)

This course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and h …
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Course ID: CT13
Average Learning Time: 120 minutes
Price: $225 | Enroll Now >>
Certification Training GCP: ICH-GCP Good Clinical Practice
Individual Course w/Certificate of Completion:

GCP: ICH-GCP Good Clinical Practice

Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP …
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Course ID: GCP001
Average Learning Time: 180 minutes
Price: $195 | Enroll Now >>
Certification Training HIPAA Training for Clinical Trial Professionals
Individual Course w/Certificate of Completion:

HIPAA Training for Clinical Trial Professionals

This Health Insurance Portability and Accountability Act (HIPAA) training for Clinical Research Professionals covers best practices for sites and
sponsors/CROs working together under
HIPAA includin …
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Course ID: CP017a
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline
Individual Course w/Certificate of Completion:

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

ICH E8(R1) is the umbrella guideline that maps to all the ICH “E”
family, including ICH E6(R3), Good Clinical Practice. The revision
modernizes clinical trial design, planning, management, conduct,

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Course ID: CP019a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Investigator Initiated Clinical Trials
Individual Course w/Certificate of Completion:

Investigator Initiated Clinical Trials

What are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved …
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Course ID: CP011a
Average Learning Time: 30 minutes
Price: $199 | Enroll Now >>
Certification Training Clinical Trials:  Preparing for an Audit or Inspection
Individual Course w/Certificate of Completion:

Clinical Trials: Preparing for an Audit or Inspection

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the res …
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Course ID: GCP006
Average Learning Time: 150 minutes
Price: $225 | Enroll Now >>
Certification Training DIGR-ACT® Solution: Critical Thinking Skills - Including Root Cause Analysis & CAPA
Individual Course w/Certificate of Completion:

DIGR-ACT® Solution: Critical Thinking Skills – Including Root Cause Analysis & CAPA

DIGR-ACT® is a solution that uses critical thinking for issues prevention and management.
As more and more data are being made available, there is a lack of understanding how to use the data effe …
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Course ID: CP001a
Average Learning Time: 60 minutes
Price: $399 | Enroll Now >>
Certification Training Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA
Individual Course w/Certificate of Completion:

Clinical Trials: Application Process to Conduct FDA-regulated Clinical Trials in USA

The Investigational New Drug Application (IND) is a submission through which the sponsor seeks approval from the Food And Drug Administration (FDA) to conduct clinical studies with an investigational …
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Course ID: GCP007
Average Learning Time: 180 minutes
Price: $225 | Enroll Now >>
Certification Training Clinical Trial Monitoring: Documentation and Closure
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Documentation and Closure

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and …
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Course ID: GCP005
Average Learning Time: 180 minutes
Price: $195 | Enroll Now >>
Certification Training ICH E6(R2) GCP Training for Investigator Site Personnel
Individual Course w/Certificate of Completion:

ICH E6(R2) GCP Training for Investigator Site Personnel

This Investigator Site Personnel Good Clinical Practice (GCP) course covers the requirements of GCP for clinical trials found in ICH E6(R2) related to the role of the investigator and site personnel, …
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Course ID: CP004a
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training GCP: An Introduction to Good Clinical Practices - Part 3 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 3 of 3

This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol p …
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Course ID: ELM-903
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GCP Training: ICH E6(R2) - (Refresher Training for Novice)
Individual Course w/Certificate of Completion:

GCP Training: ICH E6(R2) – (Refresher Training for Novice)

This GCP Training: ICH E6(R2) course covers key components of the GCP requirements for clinical trials, found in ICH E6(R2), and relates to the roles and responsibilities of the investigator, sponsor, …
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Course ID: CP002a
Average Learning Time: 75 minutes
Price: $199 | Enroll Now >>
Certification Training Regulatory Affairs: Registration of Drugs Based on Monoclonal Antibodies
Individual Course w/Certificate of Completion:

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 …
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Course ID: PRA05
Average Learning Time: 180 minutes
Price: $225 | Enroll Now >>
Certification Training Good Clinical Practice for Professionals
Training Program For Professionals:

Good Clinical Practice for Professionals

Good Clinical Practice for Professionals describes how Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH …
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Course ID: GCPFP
Average Learning Time: See Program Webpage
Price: $495 | Enroll Now >>
Certification Training Clinical Trial Monitoring: Site Evaluation and Set-up
Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Site Evaluation and Set-up

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to b …
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Course ID: GCP004
Average Learning Time: 90 minutes
Price: $175 | Enroll Now >>
Certification Training GCP Refresher Training for the Experienced Professional
Individual Course w/Certificate of Completion:

GCP Refresher Training for the Experienced Professional

This Good Clinical Practice (GCP) Refresher course reviews the major requirements of GCP for clinical trials according to the global guideline ICH E6(R2) related to roles and responsibilities. The cou …
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Course ID: CP003a
Average Learning Time: 35 minutes
Price: $199 | Enroll Now >>
Certification Training EU Medical Device Regulation (EU MDR) for Professionals
Training Program For Professionals:

EU Medical Device Regulation (EU MDR) for Professionals

This EU Medical Device Regulation (EU MDR) for Professionals program includes 9 separate courses. An introductory course is used to explain how, why, and when the new regulations have come into force; …
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Course ID: EUMDR
Average Learning Time: See Program Webpage
Price: $1295 | Enroll Now >>
Certification Training Structure and Content of Clinical Study Reports (ICH E3)
Individual Course w/Certificate of Completion:

Structure and Content of Clinical Study Reports (ICH E3)

This course covers the ICH E3 Guidance as well as the E3 Questions and Answers complement. Content includes an overview of ICH E3, an overview of the clinical study report or CSR, the body of the clin …
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Course ID: CP013a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GCP: An Introduction to Good Clinical Practices - Part 1 of 3
Individual Course w/Certificate of Completion:

GCP: An Introduction to Good Clinical Practices – Part 1 of 3

Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonization (ICH) for the design, conduct, performance, monitoring, aud …
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Course ID: ELM-901
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Drug Safety: Signal Detection and Management in Pharmacovigilance
Individual Course w/Certificate of Completion:

Drug Safety: Signal Detection and Management in Pharmacovigilance

The fundamental aim of drug safety assessment is to establish what adverse reactions may be caused by a medicinal product. Factors such as seriousness, severity, and frequency of reactions are then ta …
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Course ID: PV04
Average Learning Time: 90 minutes
Price: $195 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 2 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 2 of 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
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Course ID: ELM-146
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Medical Device vs. Drug: Comparing and Contrasting
Individual Course w/Certificate of Completion:

Medical Device vs. Drug: Comparing and Contrasting

This course covers major differences between medical device and drug clinical trials, including key definitions, regulatory approval and application processes, and safety reporting, with a focus on F …
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Course ID: CP010a
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training CRO Oversight
Individual Course w/Certificate of Completion:

CRO Oversight

CRO and vendor oversight is a topic that is important to all Sponsors that are outsourcing clinical trial duties or activities to support the factors that are critical to success of their product deve …
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Course ID: CP007a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Drug Safety and Pharmacovigilance Professional Certification Program
Professional Certification Program:

Drug Safety and Pharmacovigilance Professional Certification Program

The Drug Safety and Pharmacovigilance Professional Certification Program aims to deliver students with a comprehensive overview of the requirements and concepts necessary to attain a strong understand …
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Course ID: AV01
Average Learning Time: See Program Webpage
Price: $695 | Enroll Now >>
Certification Training Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)
Individual Course w/Certificate of Completion:

Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)

This course covers an overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA). Content includes 21 CFR Part 312 relatin …
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Course ID: CP015a
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects (HSP) [Part 1 of 2]
Individual Course w/Certificate of Completion:

Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 1 of 2]

According to the Code of Federal Regulations, 21 CFR Part 50 applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, …
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Course ID: ELM-909
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Clinical Trials: 21 CFR Part 50 Subpart B - Informed Consent of Human Subjects (HSP) [Part 2 of 2]
Individual Course w/Certificate of Completion:

Clinical Trials: 21 CFR Part 50 Subpart B – Informed Consent of Human Subjects (HSP) [Part 2 of 2]

According to the Code of Federal Regulations, 21 CFR Part 50 applies to all clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the Federal Food, …
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Course ID: ELM-910
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC
Individual Course w/Certificate of Completion:

Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC

This course covers an Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC. Content includes key components of human subject protection, definitions and scope for Part …
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Course ID: CP014a
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training US Pharmaceutical Regulatory Affairs Professional Certification Program
Professional Certification Program:

US Pharmaceutical Regulatory Affairs Professional Certification Program

The US Pharmaceutical Regulatory Affairs Professional Certification Program describes the essential requirements for obtaining approval to market a new drug in the USA, the ‘NDA Process’.The program d …
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Course ID: PRA00B1
Average Learning Time: See Program Webpage
Price: $1295 | Enroll Now >>
Certification Training Good Documentation Practices and ALCOA-C
Individual Course w/Certificate of Completion:

Good Documentation Practices and ALCOA-C

In this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessa …
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Course ID: CP005a
Average Learning Time: 60 minutes
Price: $199 | Enroll Now >>
Certification Training Regulatory Affairs: Essentials for Human Medicinal Products - EU and US
Individual Course w/Certificate of Completion:

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 or …
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Course ID: PRA01
Average Learning Time: 180 minutes
Price: $225 | Enroll Now >>
Certification Training cGMP: Combination Products for Professionals
Training Program For Professionals:

cGMP: Combination Products for Professionals

This 3-part cGMP: Combination Products for Professionals program will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory …
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Course ID: COMPR
Average Learning Time: See Program Webpage
Price: $495 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 1 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 1 of 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
(Learn more)

Course ID: ELM-145
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>
Certification Training GMP: Combination Products (Drugs, Devices and Biologics) - Part 3 of 3
Individual Course w/Certificate of Completion:

GMP: Combination Products (Drugs, Devices and Biologics) – Part 3 of 3

This course will provide an in-depth explanation of combination products, including regulatory definitions, applicable regulations, the regulatory submission process, clinical trials, and manufacturin …
(Learn more)

Course ID: ELM-147
Average Learning Time: 45 minutes
Price: $199 | Enroll Now >>