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Safety Risk Communication for Medical Products

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


学部

  • Priya  Bahri, PhD, RPh

    Priya Bahri, PhD, RPh

    • Lead Pharmacovigilance and Risk Management Guidance and Policy
    • European Medicines Agency, Netherlands

    Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

  • Meredith  Smith, PhD, MPA, FISPE

    Meredith Smith, PhD, MPA, FISPE

    • Senior Director, Implementation Science Pillar Lead
    • Evidera, Inc, United States

    Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. 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 2021 DIA Annual Meeting Planning Committee. She has been a pioneer in the application of Implementation Science methods within the biopharmaceutical industry and has numerous publications in this area.

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