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Session 5: Real-World Evidence in Action: Bridging Data for Regulatory Decisions and Drug Safety
Session Chair(s)
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV
Takeda Pharmaceuticals, United States
The growing role of Real-World Evidence (RWE) in the regulatory landscape is reshaping how drug safety and efficacy are assessed. This session will explore the strategic integration of RWE in regulatory submissions and post-marketing commitments, focusing on case studies and success stories that demonstrate successful utilization of RWE across various stages of the drug development lifecycle. Speakers will discuss the practical implications of the FDA's guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products.” Emphasis will be on best practices for utilizing EHRs and claims data. The session also addresses RWE’s role in pharmacovigilance, enhancing drug safety monitoring and proactive risk management.
Learning Objective : - Understand key considerations for using RWE in regulatory submissions, including best practices for data quality, integrity, and alignment with regulatory standards
- Apply insights from FDA’s latest guidance on EHRs and medical claims data to boost compliance and RWE’s value in regulatory decision-making
- Analyze RWE’s role in improveing drug safety monitoring and assess the benefits and challenges of integration in post-marketing safety commitments
Speaker(s)
Overview of the FDA Real-World Evidence Guidance
Samer El-Kamary, MD, MPH
Takeda Pharmaceuticals, United States
Medical Director, Global Safety Lead
Leveraging Multi-national Observational Studies in Post-marketing Safety Assessment
Judith Maro, PhD, MS
Harvard Medical School, United States
Associate Professor, Department of Population Medicine