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2024 Combo Products Summit Agenda

session

Fireside Chat

October 10, 2024 @ 2:00 pm

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3:00 pm

Moderators

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi
Rumi Young, Director, Regulatory Policy, Novo Nordisk

Speakers

James Bertram, Director of the Office of Combination Products (OCP), FDA
Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA
Andrea Gray, Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER), FDA
Tina Kiang, Director, Division of Regulation and Guidance (DRG), Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ), 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 Devices, and Human Factors, Center for Devices and Radiological Health (CDRH), FDA 
Patricia Love, Deputy Director, Office of Combination Products, FDA
Annette Marthaler, Senior Regulatory Counsel, Office of Combination Products, FDA
Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
Stephanie Shapley, Associate Director for Policy, Office of Combination Products, FDA 
Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health (CDRH), FDA
Andrew Yeatts, Combination Product Policy 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 2024 Combination Products Summit Fireside Chat!

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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