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avatar for Michael Berntgen

Michael Berntgen

European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification, support to medicines for the paediatric population & for orphan diseases, provision of expertise & support in translational sciences. The department monitors the portfolio related to human medicines, manages the PRIME scheme and facilitates collaboration with downstream decision-makers, to foster timely access to medicines. Michael is a pharmacist with a PhD and a Master of Regulatory Affairs. From 1999 to 2006, he worked in the industry in Germany and the UK.