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Virtual

Oct 25, 2021 10:00 AM - Oct 26, 2021 5:15 PM

(US Eastern Standard Time)

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 and General Manager, Global Regulatory Science and Strategy

IQVIA, United States

Delphine  Saragoussi, MD, MSc

Delphine Saragoussi, MD, MSc

Executive Director, Epidemiology and Scientific Affairs

PPD, part of Thermo Fisher Scientific, 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

FDA, United States

Associate Director for Real-World Evidence Analytics, OMP, CDER

Xavier  Kurz, MD, PhD, MSc

Speaker

Xavier Kurz, MD, PhD, MSc

European Medicines Agency, Netherlands

Head of Data Analytics Workstream

Yoshiaki  Uyama, PhD, RPh

Speaker

Yoshiaki Uyama, PhD, RPh

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

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