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Pharmacovigilance and Risk Management Strategies Conference


Session 1: FDA Updates

    Session Chair(s)
      Gerald J. Dal Pan

      Gerald J. Dal Pan

      • Director, Office of Surveillance and Epidemiology, CDER
      • FDA, United States
    FDA representatives will provide updates from the Office of Surveillance and Epidemiology (OSE) within CDER and the Office of Biostatistics and Epidemiology in CBER. Topics will include postmarketing safety monitoring, an overview of pharmacoepidemiology, pharmaceutical risk management, medication error prevention, and updates on safety surveillance from the Office of Generic Drugs.
    Speaker(s)
      Gerald J. Dal Pan

      New Developments in Pharmacovigilance

      Gerald J. Dal Pan

      • Director, Office of Surveillance and Epidemiology, CDER
      • FDA, United States
      Steven A. Anderson, PhD

      An FDA Update on Pharmacovigilance and Risk Management Approaches for CBER-Regulated Biologic Products

      Steven A. Anderson, PhD

      • Director, Office of Biostatistics and Epidemiology, CBER
      • FDA, United States
      John  Peters, MD

      Experiences in Safety and Surveillance of Generic Drugs

      John Peters, MD

      • Deputy Director, Office of Generic Drugs, CDER
      • FDA, United States
      Howard  Chazin, MD, MBA

      Speaker

      Howard Chazin, MD, MBA

      • Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER
      • FDA, United States