Join us on day one of the conference 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

 

Day two of the conference will include a working group on Optimizing the Development of Regulated Digital Health Products Using Real-World Evidence and a special session on Medical Device Post-Marketing Safety Surveillance. More details on how to participate here.

 

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.

 

PANEL

Sanket Dhruva
UCSF School of Medicine

KEYNOTE

Carla Rodriguez-Watson
Reagan-Udall Foundation

SPEAKER

John Concato
Office of Medical Policy, CDER-FDA

Present a poster at this year's conference