Dr. Anne Dupraz-Poiseau is Executive Vice President at VCLS, France. Anne has a global strategic role within VCLS focused on the development of services for cell based and human tissue engineered medicinal products as well as drug/device combination products. 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 regenerative and personalized medicine.
Anne has 20 year experience working with Medtech and Biotech companies, on R&D, clinical and regulatory challenges, specifically in the areas of Oncology (in particular hematological malignancies), Spinal surgery, Orthopedics, Rheumatology, Ophtalmology, Dermatology and Wound care.
With double expertise on medical devices and medicinal products, she is actively involved in the design, preparation and management of registration applications, scientific advice procedures and provides advice on product classification, product development plan and risk management. In this context she works in close contact with Notified Bodies, European (Drug/Device) 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 Medicinal Products, Anne actively participates in the Europabio and AAT 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.
Prior to joining VCLS, Anne co-founded the regulatory consulting firm Meditest International, based in Rennes, 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.