Dr. Anne Dupraz-Poiseau has a global strategic role within Voisin Consulting Life Sciences focused on the development of services for medical devices (including in-vitro diagnostics), drug/device combination and borderline products, cell based and tissue engineered products as well as nutraceuticals. She has expertise in and works on the design and implementation of regulatory strategies. Anne manages multidisciplinary teams dedicated to complex and innovative healthcare product development programs, including for personalized medicine.
Anne works in close contact with Notified Bodies, European (Drug/Device/Food) Agencies and FDA in order to define, design and support implementation of regulatory strategies adapted to innovative healthcare products, which necessitate very often communication and co-assessment between different Authorities and bringing together different expertises.
As an expert in Advanced Therapy Medicinal Products (ATmPs) and in particular in cell based and human Tissue Engineered Products (hTEPs), Anne actively participates in the Europabio Advanced Therapies Working Group. She was active in establishing the European Regulation and continues working on related guidelines on ATmPs. Anne is in close contact with the European Commission and the EMA for evolution of European regulations.
Anne has significant experience in CE marking, 510k, PMA, pre-IDE, Request for Designation/Qualification, Scientific Advice, Centralized MAA for ATMPs and Scientific Writing. She specializes in Quality systems, such as ISO 9001 and ISO 13485, QSR (21 CFR part 820), GCP (Good Clinical Practices: ICH E6), and GLP (Good Laboratory Practices) and in risk based approach. Prior to joining VCLS, Anne was the co-founder of Meditest International, France. She began her career as Research & Development Project Manager for Medtronic Sofamor-Danek.
Anne earned her “European” Ph.D. degree jointly from the University of Dental Surgery in Nantes, France, the Free University of Berlin, Germany and the University of Medicine of Leiden, Netherlands, working on the development and evaluation of combination products aimed at bone substitution.
Anne is a member of the Board of Editors of the SCRIP Regulatory Affairs Journal.
Anne is based in our Rennes Office in France.