Global Conference on Regulatory Science 2021

October 12-13, 2021 | Virtual Conference

Speakers

Conference Proceedings

Hosted by the Harvard-MIT Center for Regulatory Science, the 2021 Global Conference on Regulatory Science took place on October 12-13 and convened academic scientists, international regulators, and industry experts to explore emerging topics at the intersection of regulatory science and therapeutic development. The two-day conference included plenary presentations, panel discussions, and multi-stakeholder working group sessions.

The theme was Digital Health and Medical Devices and conference participants discussed the challenges and opportunities for harnessing digitally enabled technologies in support of optimal patient health outcomes.

Poster Award Winners

Congratulations to the following poster presenters:

Audience Choice –
“Enhancing FDA Regulation of Artificial Intelligence/Machine Learning Algorithms” by David Jiang
“Consumer Driven Innovation and Regulatory Impact for Continuous Glucose Monitoring in Diabetes Patients” by Angela Yu

Best Poster –
“Enhancing FDA Regulation of Artificial Intelligence/Machine Learning Algorithms” by David Jiang

Setting the Stage

Welcome Remarks and Keynote: Accelerating Science Based DHT Adoption

Florence Bourgeois, Harvard-MIT CRS and Bakul Patel, FDA

Regulation and Evaluation of Digital Health Apps

Impact of the EU-MDR on Digital Health Companies

Christain Johner, Johner Institute

Panel: Regulating Digital Health Apps: An International Overview and Country Case Studies

Moderator: Ariel Stern, HBS

Evaluating Risk and Benefit in the Digital Mental Health Space: Practical and Regulatory Approaches

John Torous, BIDMC

Evidence Synthesis for Medical Devices

The Role of Registry Networks in Supporting a National System for Device Surveillance

Ralph Brindis, UCSF

Decentralized Clinical Trials

Considerations for Implementing Decentralized or Flexible Clinical Trials

Charmaine Demanuele and Robert Mather, Pfizer

Panel: Advances in Decentralized Trials and Regulatory Considerations

Moderator: Yvonne Chan, DiMe Society

Working Groups

Lightning Talk: Challenges and Opportunities in Pediatric Device Development

Florence Bourgeois, Harvard-MIT CRS

Lightning Talk: Developments in Digital Pathology, Tissue Imaging, and Artificial Intelligence

Sandro Santagata, HMS

Lightning Talk: Education in Regulatory Science

Scott Steele, URMC

Lightning Talk (Oct 12): Digital health applications, real-world evidence, and advancing digital medicine: What is the role of regulation in a rapidly evolving space?

Ariel Stern, HBS

Working Group (Oct 13): Digital health applications, real-world evidence, and advancing digital medicine: What is the role of regulation in a rapidly evolving space?

Moderators:
Ariel Stern, HBS
Jennifer Goldsack, DiMe
Jan Brönneke, hih

Closing Thoughts

Moderator: Peter Sorger, Harvard-MIT CRS