Fimea takes part in two new EU4Health Joint Actions
Fimea takes part in two Joint Actions included in the EU4Health programme funded by the European Commission.
CHESSMEN (Coordination and Harmonisation of the Existing Systems against Shortages of Medicines – European Network) is a Joint Action of 27 pharmaceutical regulatory authorities from a total of 22 EU/EEA countries. The aim of the project is to harmonise responses to medicine shortages between the Member States' authorities, thus reducing these shortages in Europe.
CHESSMEN Joint Action comprises eight work packages, one of which will be led by Fimea for the next three years. In particular, Fimea's tasks in this project focus on preventing medicine shortages and creating operating strategies aimed at minimising their impacts. The total budget of this project is EUR 10 million, 80% of which will be covered by the European Commission's EU4Health funding.
SAFE CT (Safety assessment cooperation and facilitated conduct of clinical trials) is a Joint Action of the pharmaceutical regulatory authorities from 22 EU/EEA countries. The EU Clinical Trials Regulation, under which national pharmaceutical regulatory authorities are required to work together when assessing the safety of investigational medicinal products, rather the pursuing their national processes as previously, recently entered into force. To introduce this new approach, a training process and mentoring programme for safety assessors of clinical drug trials will be developed, and a framework of sustainable safety assessment procedures for clinical drug trials will be created for future needs.
Fimea's role in the Safe CT project comprises quantitative and qualitative monitoring of the training provided for the new clinical drug trial safety assessors recruited by the Member States and participating in building up the assessors’ competence through cooperation. SAFE CT is also a three-year project. It has a total budget of EUR 5 million, 80% of which will be covered by the European Commission's EU4Health funding.
For further information, please contact:
Johanna Linnolahti, Head of Section, +358 29 522 3231
Pirjo Inki, Head of Section, +358 29 522 3362
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