返回 Agenda
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, Head of Medical Safety, Marketed Products & Plasma-Derived Thera
Takeda, 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 the regulatory landscape: Examine the key considerations and requirements for utilizing RWE in regulatory submissions, including best practices for data quality, integrity, and alignment with regulatory standards
- Apply FDA guidance effectively: Gain insights into leveraging the FDA’s latest guidance on EHRs and medical claims data, ensuring compliance and maximizing the value of RWE in regulatory decision-making
Speaker(s)
Practical Application of FDA Guidance on RWE Including Regulatory Expectations for RWE Quality
Representative Invited
FDA, United States
Case Study: Successful Integration of RWE in Label Expansion
Representative Invited
European Medicines Agency, Netherlands
Interplay of Adverse Events Spontaneous Reporting and Longitudinal Electronic Health Records for Signal Management
Representative Invited
Harvard Medical School, United States
Overcoming Barriers to Using RWE in Post-Marketing Surveillance
Representative Invited
FDA, United States