Menu Back toSession-4-Combination-Products

Pharmacovigilance and Risk Management Strategies Conference

Session 4: Combination Products

    Session Chair(s)
      Lisa Melanie Harinstein, PharmD

      Lisa Melanie Harinstein, PharmD

      • Team Leader, Division of Pharmacovigilance I, OSE, CDER
      • 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.
      John Barlow Weiner, JD

      Safety Reporting Rule for Combination Products

      John Barlow Weiner, JD

      • Associate Director for Policy
      • FDA, United States
      Suranjan  De

      Technical Specifications for Safety Reporting of Combination Products

      Suranjan De

      • Deputy Director, Regulatory Science, OSE, CDER
      • FDA, United States
      Khaudeja  Bano, MD, MS

      An Industry Perspective on Combination Products (PMSR)

      Khaudeja Bano, MD, MS

      • Senior Medical Director, Medical Affairs, Diagnostics
      • Abbott Laboratories, United States