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2023 Combo Products Summit Agenda


FDA & Health Authority Fireside Chat

November 30, 2023 @ 1:40 pm


2:45 pm


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

Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca


James Bertram, Director, Office of Combination Products

John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA

Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA

Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Stephanie Shapley, Senior Advisor, Office of Combination Products, FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

What is at the top of your mind regarding combination products? Join our FDA Fireside Chat to address your questions! In a world of uncertainty as it relates to combination product development, quality systems readiness, product approval, post-market requirements, evolving regulations and expectations, our FDA panel will address your questions anonymously or in real time in an informal, collaborative setting to get to the heart of your most pressing challenges. Don’t miss the opportunity to engage with FDA to hear their comments during the 2023 Combination Products Summit Fireside Chat!

We want to hear from you!

Submit your non-confidential questions here

All submitted questions will be compiled and asked anonymously of the FDA during the Summit. Questions will also be collected throughout the Summit, and there will be an opportunity to ask questions real-time as well.

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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