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

AI Summit Workshop

The theme for this year’s Workshop is still a work in progress. For up-to-date information, check out the workshop page.

November 13, 2024 @ 7:30 am
8:30 am

Breakfast

November 13, 2024 @ 8:30 am
8:45 am

Opening

Moderator

TBA

November 13, 2024 @ 8:45 am
9:30 am

The Solution Exchange – Focus on Trustworthiness

Moderators

Cindy Ipach, President & CEO, Compliance Insight

Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific

November 13, 2024 @ 9:30 am
10:00 am

Insight From the FDA Digital Health Center of Excellence

Moderator

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

November 13, 2024 @ 10:00 am
10:20 am

Break

November 13, 2024 @ 10:20 am
11:20 am

Establishing Trust (Fairness, Equity, Bias, Transparency, and Explainability)

Moderator

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

November 13, 2024 @ 11:20 am
12:20 pm

Overview of the HTI-1/HTI-2 Rule for Health IT

Moderator

TBA

November 13, 2024 @ 12:20 pm
1:20 pm

Lunch

November 13, 2024 @ 1:20 pm
2:50 pm

PCCP Best Practices

Moderator

TBA

November 13, 2024 @ 2:50 pm
3:50 pm

The Rulemaking Process – Establishing Regulations and Guidance in the U.S.

Moderator

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

November 13, 2024 @ 3:50 pm
4:10 pm

Break

November 13, 2024 @ 4:10 pm
5:10 pm

Fireside Chat with AI Experts – Where Are We Going? Adaptive Algorithms, Generative AI, Use Cases, and New Regulatory Frameworks

Moderator

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

November 13, 2024 @ 5:10 pm
5:25 pm

Close out

November 14, 2024 @ 7:30 am
9:00 am

Breakfast

November 14, 2024 @ 9:00 am
9:10 am

Opening

Moderator

TBA

November 14, 2024 @ 9:10 am
10:10 am

AI/ML as a Target of Malicious Cyber Attack in the Life Sciences

Moderator

Mohammed Wahab, Director, Manufacturing Cybersecurity & Validation, Abbott

November 14, 2024 @ 10:10 am
10:30 am

Break

November 14, 2024 @ 10:30 am
11:30 am

The Reimbursement Landscape for AI/ML-Enabled Medical Devices

Moderators

Cindy Ipach, President & CEO, Compliance Insight

Lacey Harbour, Regulatory Affairs Manager, Thermo Fisher Scientific

November 14, 2024 @ 11:30 am
12:30 pm

Lunch

November 14, 2024 @ 12:30 pm
2:00 pm

Global AI Regulatory Landscape Update

Moderator

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

November 14, 2024 @ 2:00 pm
3:30 pm

Pharmaceutical Case Study – AI/ML in the Drug Manufacturing Process

Moderator

TBA

November 14, 2024 @ 3:30 pm
3:50 pm

Break

November 14, 2024 @ 3:50 pm
5:20 pm

AI Working Teams – Report Out

Moderator

Team Leaders

November 14, 2024 @ 5:20 pm
5:35 pm

Close of Summit

Moderator

TBA

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