Meet the FDA: How Listening to Patients Can Help Speed Approval of Your Device

This event is jointly hosted by QB3 and UCSF-Stanford CERSI. Further details (bios, photos, talk summaries) will be added to this page as they become available.


3:30 – 3:45 pm        Welcome & Introduction: Kathy Giacomini, PhD, Co-Director, UCSF-Stanford CERSI

3:45 – 4:30 pm      Overview of the FDA Center for Devices and Radiological Health (CDRH) and Patient Preferences in Regulatory Decisions: Kathryn O’Callaghan, Associate Director for Science and Strategic Partnerships, Center for Devices and Radiological Health, FDA

4:30 – 6:00 pm     Case Study and Panel Discussion
Kevin MacDonald, Rosenman Fellow and Regulatory Consultant
Anindita Saha, Director, External Expertise and Partnerships, CDRH, FDA
Telba Irony, PhD, Chief, General and Surgical Devices Branch, CDRH, FDA
Martin Ho, MSc, Team Leader, Neurologic and Dental Biostatistics, CDRH, FDA
Leslie Wilson, PhD, Professor, Department of Clinical Pharmacy, UCSF
Michi Garrison, MS, Rosenman Fellow, VP Research and Development, Intervene

6:00 – 7:00 pm        Reception