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5th Annual CERSI Innovations in Regulatory Science Summit

Published on 10/13/2023

SUNDAY, JANUARY 7, 2024 | 9 AM - 5:30 PM PACIFIC TIME
**Hybrid Event: Virtual & In-Person Attendance**

Robertson Auditorium
Mission Bay Conference Center at UCSF
1675 Owens St, San Francisco, CA

About This Event

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) is pleased to present the fifth annual CERSI Innovations in Regulatory Science Summit, a gathering of leaders in the academia, industry, and regulatory sectors to discuss the role of regulatory science in medical product development.

The 2024 CERSI Innovations in Regulatory Science Summit will have a major focus on emerging issues in regulatory science. The summit will include panels on medical misinformation and its impact on public health, regulatory decision making among different countries, manufacturing and supply chain of medical products, and the return of our exciting panel featuring former FDA Commissioners on the latest issues facing the Agency. New this year will be an FDA Center Directors panel as well as debates on exciting topics in regulatory science.

The goal of the summit is to stimulate discussion across sectors and to critically consider lessons learned and scientific issues that need addressing to expeditiously and safely advance the development, approval, and monitoring of medical products.

Panels:

Why is Medical Misinformation Killing Us?
Variation in Regulatory Approaches Across the Globe: How Can We Work Together to Make Medical Products Commercially Viable and Available Worldwide?
Accelerating CMC Commercialization
FDA Center Directors Forum: Patrizia Cavazzoni (CDER), Peter Marks (CBER), Jeff Shuren (CDRH)
FDA Chiefs Chat: Robert Califf (invited), Scott Gottlieb, Margaret Hamburg, Mark McClellan, Janet Woodcock

Debates and Discussion:

Is Direct to Consumer Advertising Good for Patients?
Should Advisory Committees Always Have a Vote?

Remarks from:

Robert Califf, MD (invited) |FDA Commissioner, 2016-2017, 2022-present
Janet Woodcock, MD | FDA Principal Deputy Commissioner

For more information and to register, click cersisummit.com.

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