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Philippe Auclair

Senior Consultant
AKRA Team

Philippe Auclair, Pharmacist ,Ph.D.
Regulatory Affairs Expert | AKRA TEAM

Dr. Philippe Auclair brings over 30 years of experience in pharmaceuticals and the medical device/IVD industry. He holds a Ph.D. in Microbiology and Enzymology from the University of Technology Compiègne (1984) and a Pharmacy degree from the University of Clermont-Ferrand (1983).
Dr. Auclair has played pivotal roles in global harmonization efforts, serving as Secretary of the Global Harmonization Task Force (GHTF) Study Group 2 on Adverse Event Reporting and currently serving as a Technical Committee Advisor for the Global Harmonization Working Party (GHWP).
He previously served as Chairman of the Post-Market Surveillance Task Force and Clinical Investigation Task Force for EUCOMED (now MedTech Europe), the European confederation of medical device manufacturers. As an industry representative in European Commission expert groups on vigilance and clinical evaluation, and an expert in several ISO/CEN committees, Dr. Auclair has been instrumental in shaping international standards for post-market surveillance.
Among his recognitions, Dr. Auclair has received the FDA CDRH Director's Special Citation and the RAPS Global Leadership Award. He has been elected as a RAPS Fellow in acknowledgment of his contributions to regulatory science.

www.akrateam.com | philippe.auclair@akrateam.com



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