Information from EC-DG SANTE/HMA-CTFG/EMA joint training on the CT Regulation (EU)

Information from EC-DG SANTE/HMA-CTFG/EMA joint training on the CT Regulation (EU)

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.

Please find below the link to the documentation from the event. There are some interesting presentations and documents published on this webpage, which you may find useful:

EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014 | Public Health (europa.eu)