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Aisummit 2023 Horz

AI Summit 2023 Agenda

If you missed the 2023 AI Summit, here’s what we covered:

November 12, 2023 @ 7:15 am

8:15 am

Other

November 12, 2023 @ 8:15 am

8:45 am

Other

Moderator

Timothy W. HsuChief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

November 12, 2023 @ 8:45 am

9:30 am

Other

Moderators

Lacey HarbourRegulatory Affairs Manager, Thermo Fisher Scientific

Cindy IpachPresident & CEO, Compliance Insight

November 12, 2023 @ 9:30 am

10:00 am

Other

Moderator

Timothy W. HsuChief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

Speakers

Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, FDA

Troy TazbazDirector of Digital Health, Center for Devices and Radiological Health (CDRH), FDA

November 12, 2023 @ 10:00 am

10:20 am

Other

November 12, 2023 @ 10:20 am

11:20 am

Other

Moderator

Brian EdwardsFellow, Regulatory Affairs, Digital Health/Cybersecurity, Boston Scientific

Speakers

Pat BairdRegulatory Head of Global Software Standards, Philips

Brandon O’SheaSr. Regulatory Affairs Manager – Digital, GE HealthCare

November 12, 2023 @ 11:20 am

12:30 pm

Other

Moderator

TBA

Speakers

Mark SendakPopulation Health & Data Science Lead, Duke Institute for Health Innovation

Suresh BaluDirector for DIHI, and Associate Dean, Innovation and Partnership for School of Medicine, Duke Institute for Health Innovation

November 12, 2023 @ 12:30 pm

1:30 pm

Other

November 12, 2023 @ 1:30 pm

2:30 pm

Other

Moderators

Steve FrigonData Intergration Team Lead, The Christ Hospital Health Network

Lacey HarbourRegulatory Affairs Manager, Thermo Fisher Scientific

Speakers

Bakul PatelSenior Director, Global Digital Health Strategy & Regulatory Google

Gary TurnerManaging Director, Additive Manufacturing North America, Ricoh USA, Inc

November 12, 2023 @ 2:30 pm

2:45 pm

Other

November 12, 2023 @ 2:45 pm

4:00 pm

Other

Moderator

Eric Henry Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Speakers

Laura AdamsSenior Advisor, National Academy of Medicine (NAM)

Dr. Brian Anderson Chief Digital Health Physician, Mitre | CO-Founder, Coalition for Health AI (CHAI)

Bakul PatelSenior Director, Global Digital Health Strategy & Regulatory, Google

Troy TazbazDirector of Digital Health, Center for Devices an Radiological Health (CDRH), FDA

November 12, 2023 @ 5:00 pm

6:30 pm

Other

November 13, 2023 @ 7:00 am

8:00 am

Other

November 13, 2023 @ 8:00 am

8:10 am

Other

Moderator

Timothy W. HsuChief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

November 13, 2023 @ 8:10 am

9:10 am

Other

Moderator

Cindy Ipach, President & CEO, Compliance Insight

Speakers

Craig DouglassCo-founder and CEO of Contact CI – View PDF Presentation

Douglas FagalyCo-Founder, Chief Strategy Officer, E Tech Group – View PDF Presentation

Thomas FriedliDirector, Institute of Technology Management, University of St. Gallen – View PDF Presentation

November 13, 2023 @ 9:10 am

10:10 am

Other

Moderator

Pat BairdRegulatory Head of Global Software Standards, Philips

Speakers

Yarmela Pavlovic, VP Global Regulatory Affairs, Strategy & Policy, Medtronic

Annie SahaAssistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA

November 13, 2023 @ 10:10 am

10:30 am

Other

November 13, 2023 @ 10:30 am

11:15 am

Other

Moderator

Pat BairdRegulatory Head of Global Software Standards, Philips – View PDF Presentation

Speaker

Seth CarmodyVP Regulatory Strategy, MedCrypt – View PDF Presentation

November 13, 2023 @ 11:15 am

12:15 pm

Other

November 13, 2023 @ 2:15 pm

2:35 pm

Other

November 13, 2023 @ 3:15 pm

4:00 pm

Other

Moderator

Team Leaders (Invited)

Speaker

AI Working Team Co-Chairs

November 13, 2023 @ 4:00 pm

4:20 pm

Other

November 13, 2023 @ 4:20 pm

5:20 pm

Other

Moderator

Team Leaders

November 14, 2023 @ 7:00 am

8:00 am

Other

November 14, 2023 @ 8:00 am

8:10 am

Other

Moderator

Timothy W. HsuChief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

November 14, 2023 @ 8:30 am

9:10 am

Other

Speakers

Matt DiamondChief Medical Officer, Digital Health Center of Excellence, FDA

Suchi SariaCEO & Founder, Chief Scientific Officer, Bayesian Health; John C. Malone Endowed Chair/Founding Director, Malone Center for Engineering in Healthcare; Director of Machine Learning/AI & Healthcare Lab, Johns Hopkins University

November 14, 2023 @ 9:10 am

10:10 am

Other

Moderator

Eric Henry, Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Speaker

Patrick PavlickSenior Digital Diagnostics Director, Sanofi

November 14, 2023 @ 10:10 am

10:30 am

Other

November 14, 2023 @ 10:30 am

11:30 am

Other

Moderator

Matt SchmuckiAssociate Director of Automation Engineering, Vertex Pharmaceuticals

View PDF Presentation

Speakers

Hussein EzzeldinSenior Staff Fellow, Cener for Biologics Evaluation and Research (CBER), FDA

Shawn ForrestBiomedical Engineer, Center for Devices and Radiological Health (CDRH), FDA

Mike SalemAssociate Director of Data Science – Quality Assurance, Gilead Sciences

November 14, 2023 @ 11:30 am

12:30 pm

Other

Moderator

Eric HenrySenior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Speakers

Alex CadotteSenior Director, Digital Health and Imaging, MCRA

Mira JacobsActing Assistant Director, Digital Health Policy, Digital Health Center of Excellence, FDA – View PDF Presentation

Cassie SchererSenior Director US Regulatory and Global Digital Health Policy, Medtronic

November 14, 2023 @ 12:30 pm

1:30 pm

Other

November 14, 2023 @ 1:30 pm

2:15 pm

Other

Moderators

Eric HenrySenior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

Kip WolfPresident & Principal Consultant, Thaumazo Bioscience Management, Inc.

November 14, 2023 @ 2:15 pm

2:25 pm

Other

Moderator

Timothy W. HsuChief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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