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How Can We Optimally Incorporate Real World Evidence into Regulatory Decision-Making?
Session Chair(s)
Jeffrey N. Stuart, PhD
Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , 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 : Identify 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.
Speaker(s)
EMA Perspective
Tânia Teixeira, PharmD
European Medicines Agency, United States
EMA Official at the FDA
Regulatory Perspective
Nikolai Constantin Brun, MD
Danish Medicines Agency, Denmark
Co-Chair, EMA-MHA Big Data Task Force; Dir, Div for Medical Eval & Biostatistics
Patient Perspective
Jeff Allen, PhD
Friends of Cancer Research, United States
President and Chief Executive Officer
FDA Perspective
Jacqueline A. Corrigan-Curay, JD, MD
FDA, United States
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)
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