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Overview

Within the past few years there has been a lot of discussion on the generation and utilization of real world evidence (RWE). It is well-known that regulators use RWE to monitor post-market safety and to make regulatory decisions, Sponsors utilize it to support both clinical trial design and observational studies to generate treatment approaches, and healthcare systems collect and use RWE to substantiate coverage decisions. However, what are the ‘new and innovative’ RWE applications in today’s healthcare ecosystem? This conference will explore examples of unique applications of RWE, and describe novel ways stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.

Who should attend?

Professionals involved in:

  • Real World Evidence
  • Epidemiology
  • Policy
  • Regulatory Science

Learning objectives

At the conclusion of this conference, participants should be able to:

  • Explain how RWE can facilitate clinical trial design
  • Describe criteria in which RWE has been used for label expansion and discuss future applications 
  • Discuss appropriate uses for patient generated health data 
  • Identify areas where medical devices have successfully used RWE for regulatory decision-making 

Program Committee

  • Jeff  Allen, PhD
    Jeff Allen, PhD President and Chief Executive Officer
    Friends of Cancer Research, United States
  • Brian D. Bradbury, PhD, MA
    Brian D. Bradbury, PhD, MA Executive Director & Head, Data and Analytics, Center for Observational Research
    Amgen, Inc., United States
  • Paul M. Coplan, DrSc, MBA, MPH
    Paul M. Coplan, DrSc, MBA, MPH Vice President, Medical Device Epidemiology & Real-World Data Analytics
    Johnson & Johnson, United States
  • Jacqueline A. Corrigan-Curay, JD, MD
    Jacqueline A. Corrigan-Curay, JD, MD Director, Office of Medical Policy, CDER
    FDA, United States
  • Nancy  Dreyer, PhD, MPH
    Nancy Dreyer, PhD, MPH Chief Science Officer
    IQVIA, United States
  • Marni  Hall, PhD, MPH
    Marni Hall, PhD, MPH Vice President, Center for Advanced Evidence Generation Real World Insights
    IQVIA, United States
  • James  Harnett, PharmD, MS
    James Harnett, PharmD, MS Senior Director, Lead, Real World Data and Analytics, Patient & Health Impact
    Pfizer Inc., United States
  • Sophie  Janssens
    Sophie Janssens Global Head of Real World Evidence
    UCB Pharma, Inc, Belgium
  • Gabriela  Lavezzari, PhD, MBA
    Gabriela Lavezzari, PhD, MBA Senior Director, US R&D Policy and Scientific Affairs
    GlaxoSmithKline, United States
  • Debra  Schaumberg, PhD, MPH
    Debra Schaumberg, PhD, MPH Vice President, Scientific Affairs Real World Evidence
    Evidera, United States
  • Mark  Stewart, PhD
    Mark Stewart, PhD Vice President, Science Policy
    Friends of Cancer Research, United States
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