The Clinical Trials Regulation (EU) 536/2014 is foreseen to become applicable at the end of January 2022. To support Member States with its implementation, DG SANTE of the European Commission, the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency jointly organised a training course 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.
At the following link you will find all the info about the event as well as some useful presentations and documents.
