Global Conference on Regulatory Science 2022

October 11-12, 2022 | Virtual Conference

2022 Conference Speakers

Evolving Use of Real-World Evidence in Therapeutic Development and Regulation

Hosted by the Harvard-MIT Center for Regulatory Science, the 2022 Global Conference on Regulatory Science took place on October 11-12. Day one of the conference featured plenary presentations and panel discussions exploring learn how real-world evidence is informing regulatory decision-making and advancing knowledge throughout the product lifecycle. Diverse stakeholders discussed 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 included 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.

Poster Winners

Congratulations to the following poster presenters:

Best Poster
“Characterizing the Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway” by Kushal Kadakia

Audience Choice 
“Tapping the untapped potential of Regulatory: Delivering Digital Regulatory Capabilities” by Sridevi Nagarajan

Setting the Stage

Stakeholder Perspectives on Use of Real-World Evidence

Building the Infrastructure to Advance Evidence Generation

Special Guests

Closing Thoughts

Day 2 Workshop