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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Regulators’ Utilization of Real-World Data in Pharmacovigilance Activities

    Session Chair(s)
      Michael D. Blum, MD, MPH

      Michael D. Blum, MD, MPH

      • Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER
      • 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.
      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
      Michael D. Nguyen, MD

      FDA's Sentinel Program

      Michael D. Nguyen, MD

      • Medical Epidemiology, OSE, CDER
      • FDA, United States
      Agnès  Saint-Raymond, MD

      EMA Perspective

      Agnès Saint-Raymond, MD

      • Head of International Affairs, Head of Portfolio Board
      • European Medicines Agency (EMA), United Kingdom
      Rhonda  Kropp, BSN, MPH

      Improving the Use of Real World Evidence in the Regulatory Environment: Where Are We Heading in Canada?

      Rhonda Kropp, BSN, MPH

      • Director General, Marketed Health Products Division
      • Health Canada , Canada