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Virtual Event

2020年11月09日 (月) 午前 10:00 - 2020年11月10日 (火) 午後 3:45

(US Eastern Standard Time)

Fort Washington, PA 19034

Real World Evidence Conference

Welcome, Opening Remarks, and Session 1: International Updates on RWE in Regulatory Decision Making

Session Chair(s)

Nancy A Dreyer, PhD, MPH, FISPE

Nancy A Dreyer, PhD, MPH, FISPE

Founder

Dreyer Strategies LLC, United States

Debra  Schaumberg, DrSc, MPH

Debra Schaumberg, DrSc, MPH

Vice President and Global Head, Startegic Development Consulting Chair

Evidera | PPD, United States

The advent of the global pandemic of COVID-19, and the resulting imperative for rapid evidence generation, has catapulted conversations around the role of RWE in regulatory decision-making, resulting in both answers and more questions about when RWE is fit-for-use; including retractions of RWE-based manuscripts from major medical journals. This session will bring together regulatory leaders from the United States, Europe, and Japan to discuss recent lessons learned about RWE and its application to the regulatory context, and the frameworks being developed to interrogate such evidence and inform when it can be trusted.

Learning Objective :
  • Describe the current regulatory perspectives on benefits and challenges of using RWE in regulatory decisions
  • Identify challenges to use of RWE in different contexts (e.g. pre- and post-approval), and key factors considered for discriminating between RWE that can and cannot be trusted
  • Compare regulatory frameworks for consideration of RWE in regulatory decision-making in three major geographies of importance to the pharmaceutical community (US, EMA and Japan)

Speaker(s)

Robin M. Weinick, PhD

Welcome and Opening Remarks

Robin M. Weinick, PhD

DIA, United States

SVP/Managing Director Americas and Global Program Officer

Amy  Abernethy, MD, PhD

Speaker

Amy Abernethy, MD, PhD

Alphabet’s Verily, United States

President of Clinical Studies Platforms

Peter Richard Arlett, MD, FFPM, FRCP

Speaker

Peter Richard Arlett, MD, FFPM, FRCP

European Medicines Agency, Netherlands

Head Data Analytics and Methods Task Force

Yoshiaki  Uyama, PhD, RPh

Speaker

Yoshiaki Uyama, PhD, RPh

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Associate Executive Director

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