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DIA 2018 Global Annual Meeting

How Can We Optimally Incorporate Real World Evidence into Regulatory Decision Making?

    Session Chair(s)
      Jeffrey N. Stuart, PhD, RAC

      Jeffrey N. Stuart, PhD, RAC

      • Global Regulatory Director, Oncology, Immunology, and InVitro Diagnostics
      • Merck & Co., Inc., United States
    Why has the utilization of real-world data to assess efficacy lagged relative to the application of real-world safety data? Important questions must be addressed concerning efficacy data quality, endpoint surrogacy, and overall study design. This session will bring together global regulators, healthcare technologists, and drug developers to tackle the practical challenges, so that real world evidence can be more optimally incorporated into regulatory decision making.
    Learning Objective : Explore how real-world data must be collected, analyzed and reported in order to be useful in regulatory decision-making beyond the post-market safety surveillance setting.
      Representative Invited

      EMA Perspective

      Representative Invited

      • European Medicines Agency (EMA), United Kingdom
      Nikolai Constantin Brun, MD, PhD

      Regulatory Perspective

      Nikolai Constantin Brun, MD, PhD

      • Chief Medical Officer, Director of Division for Medical Evaluation and Biostats
      • Danish Medicines Agency , Denmark
      Jeff  Allen, PhD

      Patient Perspective

      Jeff Allen, PhD

      • President and Chief Executive Officer
      • Friends of Cancer Research, United States
      Jacqueline A. Corrigan-Curay, JD, MD

      FDA Perspective

      Jacqueline A. Corrigan-Curay, JD, MD

      • Director, Office of Medical Policy, CDER
      • FDA , United States