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Session 4: Combination Products
Session Chair(s)
Lisa Melanie Harinstein, PharmD
Team Leader, Division of Pharmacovigilance, FDA
FDA, United States
Combination products are therapeutic and diagnostic products that combine drugs, devices, and or biological products. Because combination products involve multiple components, they are associated with new regulatory, policy, development, and review challenges. In this session, we explore some of these emerging challenges with combination products, such as adverse event reporting and principles of human factor studies during the development of combination products.
Speaker(s)
Safety Reporting Rule for Combination Products
John Weiner, JD
FDA, United States
Associate Director for Policy, Office of Combination Products, OCPP, OC
Technical Specifications for Safety Reporting of Combination Products
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
An Industry Perspective on Combination Products (PMSR)
Khaudeja Bano, DrMed, MD, MS
Amgen, United States
Vice President, Combination Product Quality
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