Building Non-Interventional Studies for Regulatory Purposes

About this Session

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. This webinar makes the case for a build-for-purpose mindset, in which every design decision flows from a clearly defined regulatory objective.

What You'll Learn

We'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. We'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.

Webinar Speakers

Dr. Rich Gliklich, Founder, OM1

Dr. Richard Gliklich, MD is the founder of OM1 and brings decades of experience in the areas of registries, outcomes, and analytics. He is senior editor of the landmark publication by the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook "Registries for Evaluating Patient Outcomes: A User's Guide” and the 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.

Michelle Leavy, MPH, Senior Director, Registries, OM1

Michelle Leavy, MPH, is the Senior Director, Registries at OM1, where she oversees prospective observational studies and patient registries as well as projects related to improving patient registry methodology and harmonizing data and outcome measures across patient registries and clinical practice. Michelle was the managing editor of Registries for Evaluating Patient Outcomes: A User’s Guide, and she led a federally funded effort to harmonize outcome measures across registries and clinical care to support depression research. She previously managed efforts to develop harmonized outcome measures for use in patient registries under the Outcome Measures Framework (OMF) project. At OM1, she leads the Registry Center of Excellence, which provides internal and external consulting on observational study best practices. Michelle is a graduate of Columbia College and the UNC Gillings School of Global Public Health. Ms. Leavy is a recognized international expert in registry and longitudinal study design and operations.