Anne Dupraz Poiseau is a project director for medical devices, combination products and advanced therapy medicinal products at Voisin Consulting in France. Dr Dupraz Poiseau manages projects involving the design and implementation of regulatory strategy for medical devices (including in vitro diagnostics), advanced therapy medicinal products (ATMPs: cell, gene and tissue engineered products), combination products (drug-device, biologic-device, human cell- and tissue-device associations) and borderline products. She participates in the Europabio (European Association for Bioindustries) Advanced Therapies working group. She has been actively involved in the development of the European Regulation on Advanced Therapy Medicinal Products since the beginning of the European Commission consultation process in 2001. Anne has significant experience in preclinical and clinical program design and implementation, in regulatory strategy, preparation and submission of regulatory applications in Europe and the US, meeting with regulatory bodies (Notified Bodies, European Medicines Agency (EMEA) and national health Competent Authorities), risk management and in scientific writing.