Aisummit 2023 Horz

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2023 AI Summit Agenda

FDA’s PCCP Draft Guidance Deep Dive

November 14, 2023 @ 11:30 am

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12:30 pm

Moderator

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

Speakers

Alex CadotteSenior Director, Digital Health and Imaging, MCRA

Mira Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence, FDAView PDF Presentation

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

The FDA released a draft of its first regulatory guidance centered on AI-enabled products in April, the “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” Discuss with industry and FDA experts as they highlight the document’s significant features and challenges.

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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