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Real-World Evidence Conference

Translating Insights into Real-World Value.


Session 2: What’s New in RWE Generation? A Global Regulatory Update

Session Chair(s)

Marni  Hall, PhD, MPH

Marni Hall, PhD, MPH

  • Vice President, Clinical Evidence
  • IQVIA, United States
Delphine  Saragoussi, MD, MSc

Delphine Saragoussi, MD, MSc

  • Executive Director, Real-World Evidence
  • Evidera, France
This session will bring together regulatory leaders from the United States, Europe, and Japan to discuss the evolving regulatory landscape for RWE, and related emerging topics. Speakers will address forward -looking priorities, opportunities, and trends, by region, including their current thinking, latest trends, regulations, and guidance. Lessons learned from expanded use of RWE during the COVID-19 pandemic will also be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify lessons learned from the use of RWE by regulators to inform the pandemic response
  • Describe at least three trends in the use of RWE for regulatory decision making
  • Compare RWE regulatory frameworks in three major geographies

Speaker(s)

John  Concato, MD, MPH, MS

Speaker

John Concato, MD, MPH, MS

  • Associate Director for Real-World Evidence Analytics, OMP, CDER
  • FDA, United States
Xavier  Kurz, MD, PhD, MSc

Speaker

Xavier Kurz, MD, PhD, MSc

  • Head of Data Analytics Workstream
  • European Medicines Agency, Netherlands
Yoshiaki  Uyama, PhD, RPh

Speaker

Yoshiaki Uyama, PhD, RPh

  • Director, Office of Medical Informatics and Epidemiology
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan