Safety assessment cooperation and facilitated conduct of clinical trials

ongoing

Safety assessment in clinical trials plays a crucial role in respecting patient rights and wellbeing and also obtaining high quality data on safety of medicines. The new clinical trial regulation (CTR) was created to maximize efficiency and quality in the process of assessing clinical trial applications but also assessing safety after a trial is approved. To implement the concept introduced with the CTR such as safety cooperation and worksharing among member states, additional knowledge is needed. Building competence and expertise needed for the clinical trials safety assessment cooperation is the main objective of this project. Project is also dedicated to create a training process for safety assessors, support mentorship programme and also create a framework for sustainable procedures in safety assessment in clinical trials for the future.