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DIA 2021 Global Annual Meeting


Real-World Evidence: A Global Regulatory Perspective and Discussion

Session Chair(s)

Andrew  Thomson, PhD, MA, MS

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

Real-World Evidence at FDA

Robert Ball, MD, MPH, MSc

  • Deputy Director, Office of Surveillance and Epidemiology, CDER
  • FDA, United States
Peter Richard Arlett, MD, FFPM, FRCP

EU Update on Big Data and Real-World Evidence

Peter Richard Arlett, MD, FFPM, FRCP

  • Head Data Analytics and Methods Task Force
  • European Medicines Agency, Netherlands
Patrice  Verpillat, DrMed, MD, PhD, MPH

Industry Update

Patrice Verpillat, DrMed, MD, PhD, MPH

  • Head of Global Epidemiology
  • Merck Healthcare KGaA, Germany