GCP Basics: (1 day)

• ICH-GCP R2 and outlook on R3
• EU Legislation for Clinical Trials including EU Clinical Trials Regulation (536/2014)
• A Look into FDA Requirements

After presenting the history of GCP and highlighting the Declaration of Helsinki, ICH-GCP will be covered extensively. Special focus is given to the responsibilities of the different parties involved in clinical trials. Typical inspection findings will add practical aspects and will make the seminar very lively. In addition, the EU clinical trials legislation will be presented, with a focus on the EU Clinical Trial Regulation 536/2014.Transitional provisions from the old system (EU CT Directive 2001/20/EC) to the new system as well as the new EU transparency rules will be covered.  Finally, important FDA aspects will be addressed. After the course, the participant will have accrued solid GCP knowledge and will have a good understanding of the interaction of international guidelines and regional legal provisions.

Fee: 740 € (19% VAT will be added)

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