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
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.