- This event has passed.
FDA & Health Authority Fireside Chat
11-30-2023 @ 1:40 pm – 2:45 pm
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 hereAll 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.
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