Agenda ), the FDA and the EMEA have also characterised this fact as a crucial gap in the education and training of scientists evaluating the safety of drug candidates and new medicines.
Scope and objectives: We present a new and unique pan-European education and training network, which solves this shortfall by developing and establishing a comprehensive modular Education and Training Programme in Safety Sciences for Medicines (SafeSciMET). This programme will fulfil the needs of pharmaceutical industry, regulatory authorities and academia. The network, consisting of top institutes for drug safety education and research, proposes a new type, high quality and sustainable programme for education and training in Safety Sciences for Medicines (S2M). The tailor-made training courses will encompass the safety, ethical, regulatory and societal aspects in all phases of drug development, with emphasis on integrative, translational and 3Rs aspects of drug safety assessment. Individual safety professionals who wish to address specific knowledge gaps will be able to follow single courses. The modular set up also provides an excellent opportunity for following dedicated
subsets of courses, to be accredited for Continuing Professional Development (CPD). Scientists successfully completing the full programme, including an integrative MSc-thesis, will be awarded with an accredited Master of Advanced Safety Sciences of Medicines (MAS2M). All training courses and procedures will be aligned with the Bologna process.
Principle learning outcomes are novel competences in translational safety sciences, leading to safety scientists who are able to perform holistic and critical evaluations of the safety of drug candidates and new medicines by linking in vitro and animal data with patient data more effectively.
Project consortium: In this project a close collaboration is foreseen between 19 top-institutes for drug safety education and research and 16 industrial pharmaceutical companies, all members of EFPIA.