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DIA 2018 Global Annual Meeting


Risk Management: New Directions

    Session Chair(s)
      Emily  Freeman, PhD, MSc

      Emily Freeman, PhD, MSc

      • Director, Patient Centered Outcomes
      • AbbVie, Inc., United States
    This session will hear from experts involved in digital risk minimization programs. They will describe how, following a Pharmacovigilance Risk Assessment Committee (PRAC) assessment report, a pilot was initiated to assess the feasibility and operational impact of developing and implementing digital additional risk minimization measures. The session will describe how a digital approach can support tool currency, continuous availability, and educational effectiveness. It will also cover aspects of internal vision development, global and local cross-functional collaboration, tool design, regulatory authority interactions, and the critical importance of change management.
    Learning Objective : (1) Participants will understand where digital approaches can be leveraged in benefit-risk management (2) They will discover what lessons can be learned from current projects through case studies (3) They will be supported to determine top priority changes in people, process or tech to enable a move to utilise digital approached for REMS and Risk Minimisation in their own organisations
    Speaker(s)
      Helen Kathryn Edelberg, MD, MPH, FACP

      Organizing for Digital Risk Minimization

      Helen Kathryn Edelberg, MD, MPH, FACP

      • Head, Medical Safety Assessment, Innovative Medical and Global Safety Risk Mgt
      • Bristol-Myers Squibb, United States
      Mark  Perrott, PhD

      Preparing for Digital in Benefit-Risk Management: Get Ready for the Revolution

      Mark Perrott, PhD

      • Head of Development Consulting
      • Pope Woodhead, United Kingdom