Reasons to attend
You want to see the difference between the legislations in Europe and the United States? Discover them in this one-day course showing, back to back, the variation between the European regulatory requirements and the FDA Code of Federal Regulation 21 (CFR21) counterparts
What'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.
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.