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Real‑world evidence (RWE) is becoming an increasingly important component of regulatory submissions, complementing traditional clinical trial data. Converting real-world data (RWD) into evidence that meets regulatory expectations requires careful study design, rigorous methodology, and clear alignment with guidance.
In this session, Veristat’s Strategic Consulting team shares practical approaches and key decisions that strengthen evidence packages and support successful regulatory review.
RESERVE YOUR SEAT
June 30, 2026 | 12 PM EST | 5 PM BST
THE OPPORTUNITY
The use of RWD and RWE has grown rapidly alongside an evolving regulatory framework. The 21st Century Cures Act and subsequent guidance from the Food and Drug Administration (FDA), European Medicines Agency (EMA), and International Council for Harmonisation (ICH) have clarified expectations around fit for purpose data, prespecified protocols, and transparent methods. The focus now is turning these principles into practice by designing studies with the rigor and clarity needed for regulatory success.
WHAT YOU WILL LEAVE WITH
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A clear picture of where RWE is used across the product lifecycle
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A framework for evaluating whether data are fit for purpose, including relevance, reliability, and completeness
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Insight into where regulators focus during review and how to strengthen quality and reduce risk
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How to build an effective RWE strategy early in development
YOUR PRESENTER
