Objective
Background:
In current drug safety education and training in Europe, an integrative and translational approach is lacking. This shortfall has been identified by EUFEPS. The IMI (‘Strategic Research 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 modules 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 modules. The modular set up also provides an excellent opportunity for following dedicated sub-sets of modules, 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 (M4S2M). All training modules 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 of animal and patient data.
Fields of science
Call for proposal
IMI-JU-01-2008
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Coordinator
4070 Basel
Switzerland
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Participants (32)
1081 HV Amsterdam
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78464 Konstanz
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GU2 7XH Guildford
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751 05 Uppsala
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SE-175 62 Järfälla, Stockholm
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1165 Kobenhavn
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2311 EZ Leiden
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3521 AL Utrecht
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Participation ended
4051 Basel
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54052 Nancy Cedex
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69002 Lyon
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6108 Halle
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17177 Stockholm
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1010 Wien
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91405 ORSAY CEDEX
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L69 7ZX Liverpool
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1649-003 Lisboa
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10117 Berlin
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151 85 Sodertaelje
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08022 Barcelona
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94250 GENTILLY
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13353 Berlin
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55218 Ingelheim
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RG21 4FA Basingstoke
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Participation ended
CT13 9NJ Sandwich
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TW89GS Brentford
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2500 Valby
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64293 Darmstadt
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1070 Bruxelles / Brussel
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4056 Basel
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2880 Bagsvaerd
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02200 Espoo
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