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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 10: Epidemiology in Post-Approval

Session Chair(s)

Annette  Stemhagen, DrPH, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer

UBC, United States

Epidemiologic strategies and study designs play an integral part in studies of marketed products. Some studies incorporate real world data (RWD) as the sole source of information or use a hybrid model where RWD are included to complement traditional data collection. This session will explore examples of studies to meet regulatory commitments and provide insights into product use. We will address ways that epidemiology studies can support post-marketing objectives to evaluate product safety and effectiveness in a real-world setting.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Explore epidemiologic approaches to post-marketing studies using real-word data (RWD) and real-world evidence (RWE)
  • Discuss how registries can support marketed products
  • Describe the role of RWD to support post-marketing requirements


Angelika  Manthripragada, PhD, MPH


Angelika Manthripragada, PhD, MPH

Regeneron, United States

Director, Pharmacoepidemiology, Global Patient Safety

Hu  Li, MD, PhD

Post-Approval Pregnancy Safety Study: Lessons Learned from a Decade of Experience

Hu Li, MD, PhD

Gilead Science Inc., United States

Sr. Director, Real-World Evidence

Nicole  Kellier-Steele, PhD, MPH


Nicole Kellier-Steele, PhD, MPH

Eli Lilly and Company, United States

Senior Director - Global Patient Safety

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