Clinical Trial Requirements: Comparing Europe with the USA – eLearning
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|---|---|---|---|---|
| No sessions are planned at this time, however if you are interested in taking this course click here | ||||
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About this course
Reasons to attend
You want to see the difference between the clinical trial requirements in Europe and the United States? Discover them in course, showing, back to back, the variation between the European regulatory requirements and the FDA Code of Federal Regulation 21 (CFR21) counterpartsWhat's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been reviewed by the Belgian GCP Inspectorate.
Course schedule
- Course credit: 6h (3 months period to complete course)
- Complete the course at anytime, anywhere!
Course Description
This course is designed for everyone currently managing clinical trials for the FDA or who needs to understand the differences in EU and US requirements of performing clinical trials. Information is focused on fundamental topics in Europe and in the USA and what is substantially different between them. Specific forms required by the authorities are explained and include those for investigator commitment and safety forms. Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment.Programme highlight
- Regulatory Framework in EU and in US,
- Update on European Legislative requirements for Clinical Trials,
- Submission Process and Timelines,
- Institutional Review Boards/Independent Ethic Committees (21 CFR Part 56 - Institutional Review Boards - HIPAA and Informed consent),
- Protection of Study Subjects (Rules on Subject Protection),
- Understanding Investigator Obligations (FDA Form 1572, Financial Disclosure Form),
- Safety Reporting Rules,
- Public Registration of Clinical Trial Protocols and Clinical Trial Results,
- Inspections
- Comparison ICH-GCP versus EU and US requirements
Learning objectives
- Have an overview European and North-American legislation in general and in particular of regulatory documents for Clinical Trials,
- Comprehend the rules in Europe and in the USA with regards protection of human study subjects, investigator’s obligations, and safety reporting in clinical trials,
- Know how and when to use mandatory clinical trial forms in Europe and in the USA,
- Understand similarities and differences between ICH-GCP, EU & US clinical trial responsibilities.
Who should attend
- Everyone involved in international clinical research (pharmaceutical companies, Contract Research Organisations (CROs), investigators, site personnel, ethics committee members, etc
- People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.
Competencies
Trainers
No trainer yet
Inamed
Inamed GmbH
Our team has followed an in-house training session “Comparing EU and US Clinical Trial Legislation” and was really enthusiast about it. They were engaged from beginning to end and consequently learned a lot. The atmosphere during the session was so good, that the learning became a fun experience. The trainers were very knowledgeable and dynamic. We can definitely recommend this session to everyone doing clinical trials in Europe and US.