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Real world evidence (RWE) is increasingly becoming important for regulatory decision-making and beginning to touch all areas of the healthcare value chain. Historically used for post-market safety monitoring, sponsors are now beginning to use RWE to support clinical trial design and observational studies in order to generate better treatment approaches, while healthcare systems are collecting and using RWE to substantiate coverage decisions. DIA’s Real World Evidence Conference will explore new and innovative applications of RWE, and deliver cutting-edge insights in how stakeholders are leveraging RWE to advance healthcare knowledge and decision-making.

Preconference Short Course

Introduction to Real World Data for Data Geeks

Who should attend?

Professionals involved in:

  • Real World Evidence
  • Epidemiology
  • Policy
  • Regulatory Science
  • Technology Development
  • Data Analytics
  • Clinical Research

Learning objectives

At the conclusion of this activity, participants should be able to:
  • Discuss how RWE is being used today to inform biopharmaceutic development across product lifecycle
  • Describe the recent FDA strategic framework for RWD in regulatory decisions
  • Evaluate the future applications of RWE in drug development
  • Appraise how mobile technologies, AI, machine learning, and other technologies are being used to generate RWE
  • Evaluate how patient reported outcomes, EHR, and other patient data is expanding the resources for RWE
  • Discuss “lessons learned” from current uses of RWE, and how these can be applied for other future applications of RWE

Program Committee

  • Jeff  Allen, PhD
    Jeff Allen, PhD President and Chief Executive Officer
    Friends of Cancer Research, United States
  • Bart  Barefoot
    Bart Barefoot Director, Real World Evidence Policy & Advocacy
    GlaxoSmithKline, 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 Scientific Officer & Senior Vice President
    IQVIA, United States
  • Marni  Hall, PhD, MPH
    Marni Hall, PhD, MPH Vice President, Clinical Evidence
    IQVIA, United States
  • James  Harnett, PharmD, MS
    James Harnett, PharmD, MS Senior Director, Lead, Real World Data and Analytics, Patient and Health Impact
    Pfizer Inc., United States
  • Sophie  Janssens
    Sophie Janssens Vice President, Global Head of Real World Evidence
    UCB Pharma, Inc, Belgium
  • 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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When is Real World Evidence Ready for Prime Time?

Preconference Short Course

Introduction to Real World Data for Data Geeks

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