PROJECT NAME

Safety assessment cooperation and facilitated conduct of clinical trials (SAFE CT)

SUMMARY

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 work-sharing 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.

DURATION OF THE PROJECT

1.5.2022 – 30.4.2025

BUDGET

6,25 million
EC co-financing 5 million (80%)

PARTNERS                                                  

22 EU/EEA members

Coordinator: HALMED (Croatia)

Beneficiary partners: INFARMED (Portugal), FAHMP (Belgium), HPRA (Ireland), AEMPS (Spain), BfArM (Germany), FIMEA (Finland), JAZMP (Slovenia), SÚKL (Czech Republic), AGES (Austria), OGYÉI (Hungary), DKMA (Denmark), ANSM (France), NoMA (Norway), SMCA (Lithuania), MPA (Sweden), AIFA (Italy), VWS (Netherlands), EOF (Greece), SAM (Estonia), MMA (Malta), SAM (Latvia).

ROLE OF JAZMP

JAZMP is involved in the implementation of the Clinical Trials Regulation in Slovenia as a national competent authority and represents Slovenia in the implementation of the Regulation in the European Economic Area. The Safe CT project provides support during the transition period until 2025.

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HaDEA). Neither the European Union nor HaDEA can be held responsible for them.

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