Welcome and Summary of Highlights of Day Before Moderator

Moderators: Chin-Wei Soo, Global Regulatory Head - CMC/Devices and Combination Products, Genentech; Rumi Young, Director, Regulatory Policy, BD

Speakers: Chelsea O'Connell, Director, Global & Regulatory and R&D Policy at Amgen; Kristina Lauritsen, Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER) FDA; Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA; Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC

Moderator: Fran DeGrazio, Executive Advisor, Kymanox
Speakers: Carolyn Dorgan, Director, Technical Services, Suttons Creek; Sujith Kallur, Regulatory Affairs Lead, Wearable Injectors, BD Medical Pharmaceutical Systems; 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; Krishna Venugopalan, Vice President - Combination Products, Drug Delivery and Sterile Packaging, AbbVie

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Moderator: Jiaying Shen, Distinguised Scientist, Merk
Speakers: Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER), FDA; Carrie O'Donel, Principal Device Engineer, Teva Pharmaceuticals; Jen Soosaar, Director of Human Factors, Core Human Factors, Inc; Colin Roscoe, Principal Human Factors Scientist, Teva Pharmaceuticals

Moderator: Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: Edison Alvarez, Sr. Director, Regulatory Strategic Planning for Cybersecurity, BD; Aftin Ross, Acting Deputy Director - Division of All Hazards Response, Science & Strategic Partnerships, Center for Devices and Radiological Health (CDRH), FDA; Fubin Wu, Co-founder and President, GessNet Safety Engineering;

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

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative