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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 9: Real-World Evidence Support of Clinical Development Programs

Session Chair(s)

Barbara  Hendrickson, DrMed, MD

Barbara Hendrickson, DrMed, MD

Clinical Associate, Pediatric Infectious Diseases

University of Chicago, United States

Real-world data (RWD) and real-world evidence (RWE) are commonly leveraged to inform the safety of marketed products and may also be used to support clinical development programs. RWD can assist in the evaluation of safety signals arising from clinical trial data and contextualizing clinical trial event rates. Additionally, RWD/RWE can play an important role in product submissions and approvals. In 2021, FDA issued multiple draft guidance’s related to the use of RWD/RWE to support regulatory decision-making, including conveying a framework to evaluate the potential use of RWD to generate RWE to help support the approval of new indication(s) for marketed drugs. This session will address ways that RWD/RWE can support clinical trial signal evaluation, IND reporting decisions as well as clinical development programs and submissions for approval of drugs and biological products.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe various ways RWE/RWD are utilized in regulatory interactions during clinical development
  • Discuss FDA Draft Guidances on RWD/RWE and their applicability
  • Describe the role of RWE in the evaluation of safety signals arising from clinical trial data
  • Appraise potential approaches to identify reference adverse event rates to contextualize clinical trial data


Solomon  Iyasu, DrMed, MPH

Use of Real-World Data (RWD) and Real-World Evidence (RWE) in Clinical Development and Regulatory Decision Making

Solomon Iyasu, DrMed, MPH

Iyasu Epi-RWE Strategy LLC , United States


Kimberly  Smith, MD, MS

US FDA and Real-World Evidence

Kimberly Smith, MD, MS

FDA, United States

Real-World Evidence Analytics Team, Office of Medical Policy, CDER

Simone P. Pinheiro, MSc

Role of Real-World Evidence in the Evaluation of Safety Signals Arising from Clinical Trial Data and Contextualizing Clinical Trial Event Rates

Simone P. Pinheiro, MSc

AbbVie, United States

Head, PharmacoEpidemiology Center of Excellence (PeCoE)

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