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DIA 2018 Global Annual Meeting


Generic Drug Products: Comparison of Safety Profile With Branded Cousin

    Session Chair(s)
      Howard  Chazin, MD, MBA

      Howard Chazin, MD, MBA

      • Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER
      • FDA, United States
    This forum will discuss how FDA interprets generic drug regulation and safety reporting requirements along with review practices, ethics considerations, and guidance and labeling development to monitor and ensure generic drug safety.
    Learning Objective : Summarize how pre- and post-market elements of generic drug safety and surveillance integrate understanding of critical clinical elements of performance; Compare risk/benefit considerations for patients versus healthy volunteers in bioequivalence (BE) studies and effects on enrollment criteria and safety monitoring.
    Speaker(s)
      Karen B. Feibus, MD

      FDA Perspective

      Karen B. Feibus, MD

      • Lead Medical Officer, CSSSS, Office of Generic Drugs, CDER
      • FDA, United States
      Aaron  Kesselheim, JD, MD, MPH

      Academic Perspective

      Aaron Kesselheim, JD, MD, MPH

      • Associate Professor of Medicine, Center for Bioethics
      • Harvard Medical School, United States
      Kiran  Krishnan, PhD

      Industry Perspective

      Kiran Krishnan, PhD

      • Senior Vice President, Global Regulatory Affairs
      • Apotex Inc, United States