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Pharmacovigilance and Risk Management Strategies Conference

Session 11: Hot Topics

    Session Chair(s)
      Michael  Richardson, MD, FFPM

      Michael Richardson, MD, FFPM

      • International GPV&E and EU QPPV
      • Bristol-Myers Squibb, United Kingdom
    This session will cover areas of drug safety which are problematic and require industry and regulators to work together in managing data in the post-approval space, in particular from multiple sources, both structured and unstructured data collection activities. Speakers will present on projects looking at what data can be of value to identifying signals and safety evaluation, how to manage real-world data such as the sentinel programs, and how best to utilize the specific risk management effectiveness evaluations through moving to a digital platform. Speakers will present on their topics then a joint panel for a Q&A will take place.
      Mark  Perrott, PhD

      Digital Approach to Risk Minimization

      Mark Perrott, PhD

      • Head of Development Consulting
      • Pope Woodhead, United Kingdom
      Jeremy  Jokinen, PhD, MS

      Value of Safety Information Data Sources

      Jeremy Jokinen, PhD, MS

      • Senior Director, Safety Decision Analytics
      • AbbVie, Inc., United States
      Peter  Verdru, MD


      Peter Verdru, MD

      • Vice President, Head of Patient Safety
      • UCB Biopharma S.P.R.L., Belgium
      Vicki  Edwards, RPh


      Vicki Edwards, RPh

      • Vice President, Pharmacovigilance Excellence and QPPV
      • AbbVie, Inc., United Kingdom
      D. Tyler  Coyle

      Sentinel ARIA Process

      D. Tyler Coyle

      • Medical Officer
      • Food and Drug Administration, United States