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Real-World Evidence: A Global Regulatory Perspective and Discussion
Session Chair(s)
Andrew Thomson, PHD, MA, MS
Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
The aim of this session is for senior regulators from both EMA and FDA to provide an overview of real- world evidence and data initiatives, standards and perspectives,. There will then be the opportunity for the audience to put questions to the presenters.
Learning Objective : Discuss the global landscape for the use of real- world evidence and data; Describe some scenarios where such evidence may be put to use for regulatory decision-making; Engage in dialogue with senior regulators from FDA and EMA.
Speaker(s)
Robert Ball, MD, MPH, MSC
Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Real-World Evidence at FDA
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
EU Update on Big Data and Real-World Evidence
Patrice Verpillat, DrMed, MD, PHD, MPH
Head of Real World Evidence, European Medicines Agency, Netherlands
Industry Update
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