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Pharmacovigilance and Risk Management Strategies Conference


Session 10: Regional Updates

    Session Chair(s)
      E. Stewart  Geary, MD

      E. Stewart Geary, MD

      • Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ
      • Eisai Co., Ltd., Japan
    This session focuses on countries or regions where pharmacovigilance regulations are in transition or where recent updates can present compliance issues for clinical trial Sponsors or Marketing Authorization Holders. The Eurasian Economic Union (EAEU), which includes Russia and a number of states in northern Eurasia, now has a Good Pharmacovigilance Practice (GVP) guideline and requirement for a QPPV, which will be described and explained. In Japan the “Three Officer System” is undergoing revisions in the face of a number of compliance issues that have surfaced in that country and the countries Good Postmarketing Survey Practice (GPSP) is also being modified. An update on the implementation of Vanessa’s Law (the Protecting Canadians from Unsafe Drugs Act), one of the most significant changes to the Canadian Food and Drug Act in 50 years, and its implications for pharmacovigilance in that country will also be presented.
    Speaker(s)
      Shinobu  Uzu, MSc

      The Evolving Situation in Japan: The “Three Officer System” and GPSP

      Shinobu Uzu, MSc

      • Chief Safety Officer
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
      Melissa  Hunt, MSc

      Modernization Efforts in Canada: The Regulatory Review of Drugs and Devices and Vanessa’s Law

      Melissa Hunt, MSc

      • Scientific Manager
      • Health Canada, Canada
      Annette S. Williams, MBA, RPh

      CRO Perspectives on New PV Requirements in the EAEU

      Annette S. Williams, MBA, RPh

      • Vice President, Lifecycle Safety
      • IQVIA, United States
      Tatyana  Prokhorova

      What New EAEU PV Obligations Mean for a Global Company with a Focus on Russia

      Tatyana Prokhorova

      • Cluster Safety Lead
      • Pfizer LLC, Russia EAEU/Ukraine QPPV, Russian Federation