Professor Jean-Hugues Trouvin graduated in Pharmacy and received his State Doctorate in Pharmacology from the University of Paris. He developed a carrier as Professor of Pharmacology and Pharmacokinetics in parallel with regulatory activities as experts for the Regulatory Agencies. In France, he was chairman of the French biotechnology working party from 1989 to 1993.
He was appointed as Director of the Directorate for Evaluation of Medicinal products and Biologics at the French medicine agency (AFSSAPS) from 2001 to July 2007. At the European level, he was the French representative of the biotechnology/pharmacy working party (BWP) from 1986 until 2001 when he was elected as Chairman of this Working Party and reelected for three new terms and he completed his mandate in February 2014. He was the French representative for the Committee for Advanced Therapy medicinal products (CAT) from its opening (2009) to Sept. 2012.
During his regulatory carrier, he has been involved in the drafting of many guidelines, concept papers for the development of biologicals and biotechnology-derived medicinal products (including monoclonal antibodies). He took part in the elaboration and finalization of the EU regulation and technical requirements for biologicals, biotechnology-derived products, biosimilars and lastly the advanced therapy medicinal products which consist of cell therapy, gene therapy and tissue engineering medicinal products. He also contributed to the ICH process, for the biological topics and guidelines from 1994 up to 2008.
After he left his regulatory activities in 2014, he returned full time to his academic position as professor and hospital pharmacist, at Paris Descartes University, school of Pharmacy, in the department of Health Product and Public Health, head of the Unit for Pharmaceutical Development and Innovation and at the Central Pharmacy of the Parisian Hospital Group (AP-HP), head of the Research and Development department.
He retired in October 2019 but maintained his activities at IABS (International Alliance for Biological Standardization) as chairman of the European affiliate and contributing in the organization and holding of meetings, workshops or webinars dedicated to technical and regulatory issues on biological/biotechnological medicinal products, including vaccines, recombinant proteins and cell and gene therapy products.
