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Sheraton Philadelphia Downtown Hotel

Oct 24, 2024 7:30 AM - Oct 25, 2024 4:10 PM

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Opening Remarks and Session 6: Sand in Your Shoes? The Nitty-Gritty in Generating Regulatory-Grade RWE Using Emerging Data Sources and New Platforms: Global Perspectives

Session Chair(s)

Rachele  Hendricks-Sturrup, DrSc, MA, MSc

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Research Director, Real-World Evidence

Duke-Robert J. Margolis, MD, Center for Health Policy, United States

The number of real-world data (RWD) sources available to generate real world evidence (RWE) has been increasing rapidly in recent years. The increasing availability and ease of access to data has been accompanied by numerous guidance documents and position papers among regulators, health technology assessment (HTA) bodies, and others that provide principled approaches to assessing fit-for-purpose RWD. While these documents and papers have enabled innovation in practice, they are accompanied by complexities that warrant the need for both pragmatism and close partnership and alignment of expectations among RWE developers and end-users.

Learning Objective :
  • Describe early signs of alignment on RWE standards, considerations, and definitions among regulators globally, including ongoing developments
  • Describe the need for current guidance documents to be applied pragmatically to balance data innovation with scientific rigor
  • escribe environmental, system, and study-specific challenges to leveraging RWE and solutions that balance RWD limitations with opportunities to improve population and patient health

Speaker(s)

Lina  Titievsky, PhD, MPH

Speaker

Lina Titievsky, PhD, MPH

GlaxoSmithKline, United States

Senior Director and Head of Hepatology Epidemiology

Christian  Hampp, PhD, FISPE

Speaker

Christian Hampp, PhD, FISPE

Regeneron, United States

Senior Director, Pharmacoepidemiology

Jeffrey  Brown, PhD

Speaker

Jeffrey Brown, PhD

TriNetX, United States

Chief Scientific Officer

Mina  Tadrous, PharmD, PhD, MS

Speaker

Mina Tadrous, PharmD, PhD, MS

University of Toronto, Canada

Assistant Professor

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