BfArM GCP Dialog

07 May 2019

Bonn, Germany

BfArM, one of the two German regulatory authorities, invites to a dialog about GCP requirements subsequent to the June 2017 effective date of ICH E6 (R2) that led to a number of new specifications and amendments of that guideline.

The increased use of modern information technology and the extensive outsourcing of sponsor tasks to CROs and other service providers in clinical trials were the primary triggers for the GCP guideline amendment. Thus, the main topics of the BfArM event include structural and record management demands for clinical trials as well as GCP requirements for investigators and sponsors to ensure accurate reporting, interpretation and verification of the obtained clinical trial information.

Dr. Hendrik Stempel, SanaClis’ Clinical Trial Coordinator Germany, will attend the meeting, participate in the dialog and ensure that SanaClis is applying best practices in clinical trial conduct as demanded by ICH E6 (R2) and expected by German regulators.

For more information about the event visit https://www.bfarm.de/DE/Service/Veranstaltungen/Dialogveranstaltungen/2019/190507-GCP.html;jsessionid=782B33FFAD9FDA6A3EC2161CA7011615.2_cid319