The Westin Cincinnati

Moderator: To be determined

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

Speakers: Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
Troy Tazbaz, Director of Digital Health, Center for Devices and Radiological Health (CDRH), FDA;

Moderator: Brian Edwards, Fellow, Regulatory Affairs, Digital Health/Cybersecurity, Boston Scientific
Speakers: Pat Baird, Regulatory Head of Global Software Standards, Philips; Brandon O'Shea, Senior Manager Affairs Manager at GE HealthCare

Moderators: Steve Frigon, Data Integration Team Lead, The Christ Hospital Health Network; Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Speakers: Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory Google; Gary Turner, Managing Director, Additive Manufacturing North America, Ricoh USA, Inc

Facilitator: Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals

Moderator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speakers: Laura Adams, Senior Advisor, National Academy of Medicine (NAM);
Dr. Brian Anderson, Chief Digital Health Physician, Mitre | CO-Founder, Coalition for Health AI (CHAI);
Bakul Patel, Senior Director, Global Digital Health Strategy & Regulatory, Google
Troy Tazbaz, Director of Digital Health, Center for Devices and Radiological Health (CDRH), FDA

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

Moderator: Cindy Ipach, President & CEO, Compliance Insight
Speakers: Douglas Fagaly, Co-Founder, Chief Strategy Officer, E Tech Group
Thomas Friedli, Director, Institute of Technology Management, University of St. Gallen

Moderator: Pat Baird, Regulatory Head of Global Software Standards, Philips
Speaker: Yarmela Pavlovic,, VP Global Regulatory Affairs, Strategy & Policy, Medtronic; Annie Saha, Assistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA

Moderator: Pat Baird, Regulatory Head of Global Software Standards, Philips
Speakers: Seth Carmody, VP Regulatory Strategy, MedCrypt
Jessica Wilkerson, Senior Cybersecurity Policy Advisor, Center for Devices and Radiological Health (CDRH), FDA

Facilitators: Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific
Toni Manzano, Co-Founder & CSO, Aizon; Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals;

Moderator: Team Leaders (Invited)
Speakers: AI Working Team Co-Chairs

Moderator: Team Leaders

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Speakers: Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA
TBA

Moderator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speakers: Sonja Fulmer, Acting Deputy Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA
Jeff Smith, Director, Certification and Testing Division, The Office of National Coordinator for Health Information Technology (ONC) (Invited)

Moderator: Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals
Speaker:
Hussein Ezzeldin, Senior Staff Fellow, Center for Biologics Evaluation and Research (CBER), FDA (Invited);
Tala Fakhouri, Associate Director for Policy, Center for Drug Evaluation and Research (CDER), FDA (Invited);
Shawn Forrest, Biomedical Engineer, Center for Devices and Radiological Health (CDRH), FDA (Invited); Mike Salem, Associate Director Data Science at Gilead Sciences

Moderator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding
Speakers: Alex Cadotte, Senior Director, Digital Health and Imaging, MCRA; Mira Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA; Cassie Scherer, Senior Director US Regulatory and Global Digital Health Policy, Medtronic

Moderator: Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding; Kip Wolf, Head of Technical Operations and Portfolo Management, X-Vax Technology, Inc

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative