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Session 10: Epidemiology in Post-Approval
Session Chair(s)
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
Speaker(s)
Angelika Manthripragada, PHD, MPH
Director, Pharmacoepidemiology, Global Patient Safety, Regeneron, United States
Speaker
Hu Li, MD, PHD
Sr. Director, Real-World Evidence, Gilead Science Inc., United States
Post-Approval Pregnancy Safety Study: Lessons Learned from a Decade of Experience
Nicole Kellier-Steele, PHD, MPH
Senior Director - Global Patient Safety, Eli Lilly and Company, United States
Speaker
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