Current Program

Clinical Trials in Germany according to the EU Regulation 536/2014 and 4. AMG Amendment Act

This seminar covers the implementation of the EU Clinical Trials Regulation into German Drug Law (AMG). It starts with definitions and new roles and responsibilities. For example, the term "Hauptprüfer" (principal investigator) has made it back into the law and the term "sponsor" is now supplemented by the concept of co-sponsorship. The new authorisation process and the delineation of tasks allocated to authorities and ethics committees represent another focus of this seminar. Which documents have to be submitted? And how will safety reports be handled in the future? The new transparency rules in the EU round off this training. After the seminar, the participants will have solid knowledge about the new clinical trials legislation in the EU and in particular about the implementation in Germany.

Fee: 820 € (16% VAT will be added)

For more information please contact us or register for this course directly via our registration form.