Combination Products - Part 2: Evolving Global Regulations: Health Authority Perspective | US FDA has continued to evolve the regulatory space for combination products in the United States, EU MDR implementation is upcoming. Efforts to align definitions are underway through ASTM International…
Speakers
Senior Program Manager, Office of Combination Products, FDA/CDER
Novartis Global Head MDR Implementation & DD&C Compliance, Novartis Pharma AG
Sr. Director, Regulatory Affairs, West Pharmaceutical Services
Tech Specialist & Scheme Manager - Med & Bio, BSI
Sr. Director, Global CMC-Medical Devices, Pfizer, Inc.
Director Primary Packaging Service & Projects, Vetter Development Services
Senior Consultant, Beyond Conception GmbH
President, Combination Products Consulting Services LLC
Consumer Safety Officer, Office of Pharmaceutical Quality, FDA/CDER