This on-demand course on real-world evidence (RWE) in regulatory decision-making offers a comprehensive exploration of how RWE is transforming the regulatory landscape for drugs and biologics. The course begins with an overview of global regulatory trends, highlighting the increasing acceptance and integration of RWE alongside randomized controlled trials to inform approvals, label expansions, and clinical development planning. Participants will learn to identify and assess diverse sources of real-world data (RWD) and apply practical frameworks to determine when data are “fit for purpose” for regulatory use. Through case studies and recent regulatory guidance, the course illustrates the evolution of RWE from safety evaluation to supporting efficacy, label extensions, and population bridging, underscoring the importance of methodological rigor and early engagement with regulators. The curriculum emphasizes structured approaches and frameworks for designing transparent and valid real-world studies, including the use of external control arms. Participants will learn that RWE generation for regulatory decision-making requires thoughtful study design and use of transparent frameworks to ensure data fitness and validity.

This on-demand training course takes an average of 2.5 hours to complete. Learners have access to the course for one year from the date of purchase.