Join us for plenary presentations and panel discussions to learn how real-world evidence is informing regulatory decision-making and advancing knowledge throughout the product lifecycle. Diverse stakeholders will discuss real-world evidence frameworks and present use cases in the following areas:

  • Drug development and approval in rare conditions
  • Demonstration projects
  • Post-market evidence generation for medical devices
  • Patient community perspective

 

About the Conference

Hosted annually by the Harvard-MIT Center for Regulatory Science, the Global Conference on Regulatory Science convenes academic scientists, international regulators, biopharma experts and patient groups to explore emerging topics. The goal of this year’s conference is to present interdisciplinary discussions on emerging innovations and scientific issues in the application of real-world data to support product development and regulatory decisions.

 

Stay tuned for more information on how to participate in a working group on the Use of Real-World Evidence in Digital Health Products Development on October 12.

PANEL

Sanket Dhruva
University of California San Francisco

KEYNOTE

Carla Rodriguez-Watson
Reagan-Udall Foundation

SPEAKER

John Concato
U.S. Food and Drug Administration

Present a poster at this year's conference