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Session 3: RWD and RWE in Support of Clinical Development: Designs, Guidance Gaps, and Practical Strategies
Session Chair(s)
Lina Titievsky, PhD, MPH
Head of Hepatology Epidemiology
GlaxoSmithKline, United States
Hetal Pansuria, PharmD
Vice President, Regulatory Affairs, Clinical, Nonclinical and Ad-Promo
Pacira Biosciences, United States
Using real-world data in clinical development offers valuable opportunities but also presents regulatory and methodological complexities. This session will explore hybrid and externally controlled trial designs, integration of RWD with randomized trials, and real-world challenges when applying regulatory guidance. Presenters will share case studies and practical approaches to optimize challenges presented by RWD against and regulatory expectations.
Learning Objective : - Apply case-based strategies to resolve methodological challenges and support regulatory-grade evidence generation
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Describe the design and application of hybrid and externally controlled trials using RWD
- Differentiate common sources of misalignment between RWD and regulatory guidance
Speaker(s)
Requirement for Prudence – Resolving Regulatory RWD/E Guidance Dilemmas
John Seeger, DrPH, PharmD, FISPE
RTI, United States
VIce President
Innovations in Integrating RWD with RCTs: Case Studies with External Controls and Beyond
Mingyang Shan, PhD
Eli Lilly and Company, United States
Senior Director
Speaker
Xiang Zhang, PhD
CSL Behring, United States
Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence
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