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DIA 2018 Global Annual Meeting


Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities

    Session Chair(s)
      Representative Invited

      Representative Invited

      • FDA, United States
    Regulatory agencies have conducted real-world studies of postmarketing safety concerns to inform their regulatory decision-making and explored safety surveillance methods using real-world data. This session will discuss the approach of the FDA, EMA, Health Canada, and PMDA, the challenges faced in exploring new methods and designing and conducting these studies, and future areas of research, including opportunities for international collaborative research.
    Learning Objective : Explain the progress of utilizing real-world data in regulatory activities; especially in pharmacovigilance activities; Share examples of use of pharmacoepidemiological methodology to evaluate risk of medical products.
    Speaker(s)
      Yoshiaki  Uyama, PhD

      Regulator’s Utilization of Real-World Data in Pharmacovigilance Activities

      Yoshiaki Uyama, PhD

      • Director, Office of Medical Informatics and Epidemiology
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Representative Invited

      FDA's Sentinel Program

      Representative Invited

      • FDA, United States
      Representative Invited

      EMA Perspective

      Representative Invited

      • European Medicines Agency (EMA), United Kingdom