2023 Combo Products Summit Agenda
session
FDA & Health Authority Fireside Chat
November 30, 2023 @ 1:40 pm
-
2:45 pm
Moderators
Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC
Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
Speakers
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.
