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Pharmacovigilance and Risk Management Strategies Conference


Session 3: Operational Hot Topic: Machine Learning/Artificial Intelligence in Pharmacovigilance

    Session Chair(s)
      Mariette  Boerstoel-Streefland, MD

      Mariette Boerstoel-Streefland, MD

      • Senior Vice President, Head Global Drug Safety
      • Shire, United States
      Bruce A. Donzanti, PhD

      Bruce A. Donzanti, PhD

      • Senior Group Director, Global Pharmacovigilance Innovation Policy
      • Genentech, A Member of the Roche Group, United States
    The application of Machine Learning/Artificial Intelligence (ML/AI) to support drug safety activities is in its infancy but it will drastically change the way we manage the huge volumes of potential safety data. It will have a significant impact on how we use our resources, freeing up much of what is currently used for manual, transactional tasks. Perhaps more importantly, it will improve our ability to work with traditional and new data sources and to gain better insights faster from larger sets of data.

    This session will provide a brief introduction on the need for new technologies to address the growing concerns around the ability to assess the ever-increasing volumes of data for valuable safety information, the applicability of ML/AI to address this concern, and will bring in perspectives from regulatory authorities, pharma industry, and a technology innovator, to conclude with a panel discussion on where we are going with the application of ML/AI in pharmacovigilance.
    Speaker(s)
      Bruce A. Donzanti, PhD

      Speaker

      Bruce A. Donzanti, PhD

      • Senior Group Director, Global Pharmacovigilance Innovation Policy
      • Genentech, A Member of the Roche Group, United States
      Shaun  Comfort, MD, MBA

      New Kid on the Block: Machine Learning and Why it’s Important for Pharmacovigilance

      Shaun Comfort, MD, MBA

      • Associate Director and Senior Safety Science Leader IIDO
      • Genentech, A Member of the Roche Group, United States
      Elenee  Argentinis, JD

      Machine Learning Use Cases

      Elenee Argentinis, JD

      • Offering Management Leader
      • IBM Watson Health, United States
      Shaun  Comfort, MD, MBA

      Machine Learning Use Cases

      Shaun Comfort, MD, MBA

      • Associate Director and Senior Safety Science Leader IIDO
      • Genentech, A Member of the Roche Group, United States
      Robert  Ball, MD, MPH

      Regulatory Perspective on Machine Learning in Pharmacovigilance

      Robert Ball, MD, MPH

      • Deputy Director, Office of Surveillance and Epidemiology, CDER
      • FDA, United States
      Mick  Foy

      Speaker

      Mick Foy

      • Group Manager, Vigilance Intelligence and Research Group
      • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
        Panel Discussion

      Panel Discussion

      • All Session Speakers, United States