The initiative aims to successfully establish clinical trials safety monitoring in the European Union (EU).
This would see EU Member States working together to improve trial safety through coordinated work-sharing assessment, facilitated by the EU4Health Joint Action 12.
To support these activities, ACT EU will focus on training for safety assessors, with the development of a curriculum to harmonise expertise.
It will also enable the implementation of the ICH E19 guideline on selective safety data collection.
SAFE CT
The Clinical Trial Regulation and Implementing regulation which came into force on 31 January 2022 introduced the concept of safety cooperation and work-sharing among Member States.
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating Member States. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.
More information is available under the Joint Actions section of the webpage: Heads of Medicines Agencies: Clinical Trials Coordination Group.
