Global Harmonization Opportunities in Combination Products

As regulatory bodies around the globe increasingly recognize the need to establish regulatory frameworks for combination products and other combined use systems, the implemented regulations and practices can diverge. What is the path forward to harmonize combination products and combined use experience? This panel discussion will bring in the perspectives from convergence under IMDRF and pharmaceutical expectations under ICH.

Moderator

• Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC
• Khaudeja Bano, VP Combination Product Quality, Amgen

Speakers

• Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Academy(EMA)
• Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI
• Joo Hee Kim, Professor, Regulatory Strategy center for Combination Products (RSCP), Ajou University
• Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis
• John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA