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2024 Combo Products Summit Agenda


Pre-Conference Workshop: Delving into Combination Product Challenges

October 8, 2024 @ 9:00 am


5:15 pm


Chin-Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech/Roche

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi

Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination, Johnson & Johnson

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie

Susan Neadle, Principal Consultant & President, Combination Products Consulting, LLC

There will be several session for this year’s workshop, including:

Digital Health Technologies for Remote Data Acquisition; Artificial Intelligence and Machine Learning; Mobile Medical Device Applications; Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs; and Hot Topics for Combination Products. For more information about sessions and speakers, click here. NOTE: This workshop requires a separate registration fee and is not part of the main Summit.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

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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