GCP Refresher: 

• ICH Guideline E6 (R3) (ICH-GCP)
• CTS / CTIS
• 4. AMG Änderungsgesetz und Medizinforschungsgesetz (MFG)
• Current Questions on GCP

This seminar is directed to an audience with basic GCP knowledge who would like to receive a regulatory update and would like to discuss special GCP topics. The regulatory update currently concerns the ICH-GCP Addendum as well as the EU Clinical Trials Regulation 536/2014, supplemented by the 4. Amendment to the German Medicinal Product Act. The new transparency rules in the EU will also be discussed. The discussion of current GCP/AMG questions is rounding off the training. This seminar helps participants to refresh their GCP knowledge and bring it up-to-date. The coping with the many upcoming regulatory challenges will be facilitated.

Fee: 740 € (19% VAT will be added)

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