2024 Ai Summit Logo

An artificial intelligence summit where world healthcare leaders come together.

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Presented by

AFDO RAPS Healthcare Products Collaborative

Agenda

The AI Summit speakers are handpicked by the AI Summit Strategic Committee to deliver purpose-driven content that dives below the surface, challenges status quo, engages attendees in collaborative dialogue, and provides practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussions.

Please explore the 2024 agenda for an idea of what to expect in Cincinnati.

November 12, 2024 @ 8:00 am

3:00 pm

Other

November 13, 2024 @ 7:30 am

8:30 am

General

November 13, 2024 @ 8:30 am

8:45 am

General

Moderator

Steven Mandernach, Executive Director, Association of Food and Drug Officials (AFDO)

November 13, 2024 @ 8:45 am

9:30 am

General

Moderators

Cindy Ipach, President & CEO, Compliance Insight

Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific

November 13, 2024 @ 9:30 am

10:00 am

General

Moderator

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

Speaker

Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA (Invited)

November 13, 2024 @ 10:00 am

10:20 am

General

November 13, 2024 @ 10:20 am

11:20 am

General

Moderator

Alison Sathe, Senior Vice President, Data Strategy & Analytics, Redica Systems

Speaker

Hannah Rosenfeld, Digital Health Specialist, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH) FDA

November 13, 2024 @ 11:20 am

12:20 pm

General

Moderator

Alison Sathe, Senior Vice President, Data Strategy & Analytics, Redica Systems

Speaker

Paul Hanson, Head – Life Cycle Management, Innovation, and Strategy, Takeda

November 13, 2024 @ 12:20 pm

1:20 pm

Other

November 13, 2024 @ 1:20 pm

2:50 pm

General

Moderator

Matt Diamond, Chief Medical Officer, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDA (Invited)

Speaker

Alex Cadotte,Senior Director, Digital Health and Imaging, MCRA
Kathryn Drzewiecki,
Digital Health Policy Team Lead, Center for Devices and Radiological Health (CDRH), FDA

November 13, 2024 @ 2:50 pm

3:50 pm

General

Moderator

Brian Edwards, Fellow, Regulatory Affairs, Digital Health/Cybersecurity, Boston Scientific

Speakers

Cameron Baker, Federal Government Affairs Manager, Boston Scientific
Amanda Klingler, Partner, King & Spalding

November 13, 2024 @ 3:50 pm

4:10 pm

General

November 13, 2024 @ 4:10 pm

5:10 pm

General

Moderator

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

Speakers

Laura Adams, Senior Advisor, National Academy of Medicine (NAM)
Brenton Hill, Head of Operations and General Counsel, Coalition for Health AI (CHAI)
Christina Silcox, Research Director for Digital Health, Duke Margolis Institute for Health Policy

November 13, 2024 @ 5:10 pm

5:25 pm

General

Speaker

Steven Mandernach, Executive Director, Association of Food and Drug Officials (AFDO)

November 13, 2024 @ 5:30 pm

7:00 pm

Other

November 14, 2024 @ 7:30 am

9:00 am

General

November 14, 2024 @ 9:00 am

9:10 am

General

Moderator

Brian Savoie, Senior Vice President, Education & International Programs at Regulatory Affairs Professionals Society (RAPS)

November 14, 2024 @ 9:10 am

10:10 am

General

Moderator

Mohammed Wahab, Director, Manufacturing Cybersecurity & Validation, Abbott

Speaker

Seth Carmody, Vice President of Regulatory Strategy, MedCrypt

November 14, 2024 @ 10:10 am

10:30 am

General

November 14, 2024 @ 10:30 am

11:30 am

General

Moderator

Cassie Scherer, Senior Director U.S. Regulatory and Global Digital Health Policy, Medtronic

Speakers

Pat Baird, Regulatory Head of Global Software Standards, Philips
Eric Henry,
Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice, King & Spalding

November 14, 2024 @ 11:30 am

12:30 pm

General

November 14, 2024 @ 12:30 pm

2:00 pm

General

Moderators

Cindy Ipach, President & CEO, Compliance Insight

Speaker

Julie Nadeau, Sr. Reimbursement Strategist, NAMSA

November 14, 2024 @ 2:00 pm

3:30 pm

General

Moderator

Matt Schmucki, Associate Director of Automation Engineering, Vertex Pharmaceuticals

Speakers

Robin Blankenbaker, Life Sciences Portfolio Development Executive, Siemens Digital Industries Software 
Sandra Immerman, Group Vice President, Information Technology, Pharma Services Group, Thermo Fisher (Invited)
Qi Liu, Associate Director for Innovation & Partnership ,Office of Clinical Pharmacology | Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA

November 14, 2024 @ 3:30 pm

3:50 pm

General

November 14, 2024 @ 3:50 pm

5:20 pm

General

Moderator

Team Leaders

Seema Sodhi, Data Science and Data Engineering Leader | Senior Principal Data Scientist , Medtronic

November 14, 2024 @ 5:20 pm

5:35 pm

General

Moderator

Brian Savoie, Senior Vice President, Education & International Programs at Regulatory Affairs Professionals Society (RAPS)

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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© 2024 AFDO/RAPS Healthcare Products Collaborative