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Session 11: Even Big Data Can Feel Small: Addressing Safety Evidence Challenges with Practical RWE Solutions
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
Real-world evidence is central to post-marketing safety evaluation, enabling assessment in broader populations, under routine care, and over long time. While studies involving rare outcomes or small populations may encounter feasibility and operational challenges, these hurdles also present opportunities for innovation and collaboration. These efforts can lead to more robust and adaptable study designs and improved regulatory engagement. This session features regulatory and industry experts sharing strategies with case examples on design adaptations, data sourcing, and regulatory engagement.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize the importance of performing a feasibility assessment in RWD studies
- Apply structured frameworks to guide decision-making when encountering data limitations in post-marketing safety evaluations
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Discuss strategies for engaging with regulators proactively when feasibility concerns arise during study planning and execution
Speaker(s)
Use of RWE to Support Safety Evaluations in the EU – DARWIN EU®
Andrej Segec, MPharm, MS
European Medicines Agency, Netherlands
Scientific Administrator
Large Data for Drug Safety: Real-World, Real Challenges, Real Solutions
Simone P. Pinheiro, DrSc, MSc
AbbVie, United States
Head, PharmacoEpidemiology Center of Excellence (PeCoE)
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