San Diego Regulatory Affairs Network Presents: “Leveraging Real-World Evidence in an Evolving FDA Landscape”

Thursday, March 12, 2026
5:30-7:30pm

It's a hybrid (virtual or in-person) event that is taking place in San Diego. Register before 11pm PT on 3/10 so we can get you the zoom link OR we can make sure dinner is waiting for you! Here is how/where to register.

Our own Allison Komiyama is the proud VP of Programs at SDRAN!


About the Event:
The regulatory landscape for medical products is rapidly evolving as regulators and industry alike recognize the value of Real-World Evidence (RWE) and Real-World Data (RWD) in enhancing regulatory decision-making. FDA has removed key barriers for real-world evidence and emphasizes a fit-for-purpose framework focused on data quality, relevance, and methodological rigor. Updated guidances provide clearer expectations for submissions and encourage early FDA engagement. In this presentation, Dr. Weber will examine how the evolving FDA landscape is shaping RWE use across product types and highlight practical considerations for sponsors.

Speaker Biography: Stephen Weber, MD is a former FDA medical reviewer with extensive experience evaluating the safety and effectiveness of medical products across the regulatory lifecycle.