The new EU Regulation “On Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001/20/EC” was published on 27 May 2014 and will take effect in about two years. This will fundamentally change all clinical trials procedures, especially because of the introduction of a common European evaluation procedure for clinical trials.
One of ClinTriCare’s Senior Clinical Project Leaders informed herself at an event hosted by the German Federal Institute for Drugs and Medical Devices (BfArM) on the Regulation (EU) 536/2014 on Clinical Trials on Medicinal Products for Human Use on 23 January 2015 in Bonn about the changes to be expected. Particularly exciting is the implementation of the future participation of ethics committees in the evaluation process, which must be regulated individually at national level.
The presentations by BfArM representatives, ethics committees, industry associations and the German Federal Ministry of Health were intensively discussed during the event.