The Journey to Bringing a Diagnostic Screening Algorithm to Market: Validation, Product Design, and Regulatory Considerations

November 16 @ 9:10 am – 10:10 am

Engage as we examine the do’s and don’ts of bringing an AI algorithm used to screen rare diseases from inception through regulatory clearance. Discuss and share your own thoughts and experiences as we examine Sanofi’s!

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Moderator

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

Speakers:

Patrick Pavlick, Senior Digital Diagnostics Director, Sanofi

The Westin Cincinnati

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Cincinnati, OH 45202 United States + Google Map

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About the Association of Food and Drug Officials (AFDO)

The Association of Food and Drug Officials (AFDO) is a well-recognized national organization that represents state, territorial, and local regulatory. The Association’s principal purpose is to act as the leader and a resource to state, territorial, and local regulatory agencies in developing strategies to resolve and promote public health and consumer protection related to the regulation of food, medical products, and cosmetics. Visit AFDO at www.afdo.org.

About Regulatory Affairs Professionals Society (RAPS)

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. www.raps.org.