With the implementation of the CTR, the clinical trials pharmacovigilance (PhV) landscape is changing significantly with the establishment of clinical trial safety monitoring, where Member States collaborate to improve trial safety through a coordinated work-sharing assessment. 

The work is directly connected with the activities of the EU4Health Joint Action Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT), an initiative to facilitate a smooth transition by enabling cooperation, providing funding for necessary resources and developing skills through training. 

The annual SAFE-CT Safety Assessor event, hosted by EMA as part of the activities of ACT EU’s priority action on safety monitoring, was well attended by PhV assessors from across the EU. The event highlighted the importance of safety monitoring as a scientific and procedural continuum in clinical trials. Speakers from industry and regulatory authorities (SwissMedic) provided insight into their safety monitoring procedures. In dedicated workshops, the assessors discussed case studies related to the decision-making process in safety monitoring. 

A final SAFE-CT event is planned for 2025.