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Session 1: RWE Regulatory Update: Perspectives from Around the Globe
Session Chair(s)
Motiur Rahman, PhD, MPharm, MS
Senior Epidemiologist & Policy Advisor, Real World Evidence Analytics, OMP, CDER, FDA, United States
Namangolwa Jane Mutanga, MD, PhD, MPH
RWE Reviewer, Division of Analytics and Benefit Risks Assessment, FDA, United States
The use of real-world data and evidence (RWD/RWE) to support regulatory decisions for drug and biological products including premarket effectiveness determinations and postmarket study requirements is expanding, bringing with it evolving standards, frameworks, and expectations for data quality and study rigor. In this session, representatives from regulatory agencies provide updates on the foundational issues shaping the next generation of RWD/RWE-based regulatory science. The participants will discuss issues such as fit-for-purpose data assessment, study design standards, bias identification and mitigation, outcome ascertainment, data standards compliance, and the evidentiary role of RWE within the totality-of-evidence framework for demonstrating substantial evidence of effectiveness.