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Harnessing Real-World Data to Generate Real-World Evidence for Regulatory Safety Studies
Session Chair(s)
Alicia Gilsenan, PhD, MS, RPh, FISPE
Vice President, Epidemiology
RTI Health Solutions, United States
Session will focus on considerations when using real-world data for post-marketing safety studies, with use cases provided.
Learning Objective : Identify specific study design and analytic challenges related to the safety of medical products, with a focus on rheumatology and ophthalmology; Describe key elements to consider when identifying real-world data sources to generate real-world evidence.
Speaker(s)
FDA RWE Program and Considerations in Assessing Validity of Safety Studies using RWD
Marie Bradley, PhD, MPH, MPharm
FDA, United States
Senior Advisor Real-World Evidence Analytics, OMP, CDER
Value of Real-World Data/Real-World Evidence to Assess Post-marketing Safety: Use Case- Ophthalmology
Angelika Manthripragada, PhD, MPH
Regeneron, United States
Director, Pharmacoepidemiology, Global Patient Safety
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