Join us for a short focused session with 3 Mini episodes (10Mins/eps.) which will enable attendees to better leverage critical real-world evidence (RWE) in regulatory submissions, with a focus on the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). With extensive expertise in US data and solving complex evidence generation challenges, Dr. Jason Simeone will present recent initiatives intended to foster the use of RWE in regulatory submissions, key contexts for use, and practical advice. You can watch them anytime to learn!

EP 1: Decoding FDA Activity in RWE : Highlights and Communication Strategies for Small Sponsors

EP 2: Using RWE Across the Product Lifecycle : Overview and Use Cases for Sponsors with Limited Resources

EP 3: From Theory to Approval: Analyzing Successful and Unsuccessful RWE Usage in FDA Submission