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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)
Real-World Evidence at FDA
Robert Ball, MD, MPH, MSc
FDA, United States
Deputy Director, Office of Surveillance and Epidemiology, CDER
EU Update on Big Data and Real-World Evidence
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force
Industry Update
Patrice Verpillat, DrMed, MD, PhD, MPH
European Medicines Agency, Netherlands
Head of Real World Evidence
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