As regulators place increasing weight on real-world evidence, non-interventional study designs are taking on a larger role across the pharma life cycle. The problem: too many are designed backwards, built from the data that happens to be available rather than from the regulatory question they need to answer. Join OM1 Founder Dr. Rich Gliklich and Senior Director of Registries Michelle Leavy for a webinar that makes the case for a build-for-purpose mindset, in which every design decision flows from a clearly defined regulatory objective.They’ll cover the evolving FDA and EMA landscape, how regulators evaluate fit-for-purpose evidence, and a single framework for designing registries, observational studies, and external control arms. They’ll discuss three real case studies spanning label expansion, long-term follow-up, and an external control arm, and the technology and AI that now make regulatory-grade RWE feasible at any scale.
Speakers
Founder
OM1
Dr. Richard Gliklich, MD is the founder of OM1 bringing decades of experience in registries, outcomes, and analytics. He is senior editor of the AHR) handbook "Registries for Evaluating Patient Outcomes: A User's Guide” and PI for the Outcomes Measures Framework, which focuses on standardization of outcomes measurement. He has led several key national and international efforts focused on evaluating the safety, effectiveness, value and quality of healthcare. Dr. Gliklich also holds several patents for both health outcomes systems and medical devices.
