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Safety Risk Communication for Medical Products

In this virtual training course, learn how to enhance the effectiveness of safety risk communication in light of evolving regulatory expectations.


Faculty

  • Meredith  Smith, DrPH, PhD, MPA

    Meredith Smith, DrPH, PhD, MPA

    • Director, Risk Management, Global Drug Safety, Research and Development
    • Alexion Pharmaceuticals, United States

    Meredith Smith is Risk Management Director at Alexion, Inc. where she leads a team responsible for medicinal product benefit-risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER. Currently, she is the Pharmacovigilance Track Chair for the 2019 DIA Annual Meeting Planning Committee. Recently, she led the effort to develop the RIMES Statement, a set of quality reporting guidelines for risk minimization evaluation studies.

  • Priya  Bahri, PhD, RPh

    Priya Bahri, PhD, RPh

    • Principal Scientific Administrator
    • European Medicines Agency, Netherlands

    Priya Bahri, PhD, at EMA since 1996, is now EMA's lead for pharmacovigilance guidelines (EU-GVP) and research into risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. In that role she collaborates closely with patient, healthcare professional, academic and industry organisations as well as WHO and has participated in ICH and CIOMS working groups. She is active in the learned societies ISoP and ISPE and provides lectures and research advice to the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

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