Medicinal products

EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014

9-10 March 2021

The Clinical Trials Regulation (EU) 536/2014 is foreseen to become applicable at the end of January 2022. In order to support Member States with its implementation, DG SANTE of the European Commission, the European Medicines Agency and the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency jointly organised a training on 9-10 March, 2021. Assessors, inspectors and ethics committee members from each EU/EEA Member State were invited to attend the training. The aim of the training was to provide an overview of key changes under the Clinical Trials Regulation.

Additional supporting documents can be found on Eudralex-10. Volume 10 of the publication "The rules governing medicinal products in the European Union" contains links to guidance documents applying to clinical trials. These documents, amongst others, include:

Recordings of the training (for password protected publication):

Written answers to questions from the training:


Day 1

Day 2