GCP Basics: (1 day)

• ICH-GCP including Addendum
• 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 current and the future EU clinical Trials Legislation will be presented, with an increasing focus on the EU Clinical Trials Regulation 536/2014. Finally, important FDA aspects are being 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.