Combination Products Summit Workshop
All sessions are in CST.
Breakfast
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesNotified Body Opinion Workshop – Experiences and Lessons for Combination Products in EU
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesLeading Facilitators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie
Facilitators: Arabe Ahmed, Bsi Group; Timothy Chesworth, Senior Director Regulatory Affairs - Devices & Digital Therapeutic, AstraZeneca; Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie; Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer
FDA Office Hours
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesFacilitators: James Bertram, Director, Office of Combination Products (OCP), FDA; John “Barr” Weiner, Associate Director for Policy, Office of Combination Products (OCP), FDA
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesCombination Products Risk Management: Integration of ICH Q9(R1) and ISO 14971:2019
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesLeading Facilitators: Tine Albeck, Senior Quality Assurance Professional, ALK A/S
Facilitators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Rick Wedge, Compliance Lead / Associate Research Fellow, Pfizer; Milind Ganjawala, Division Director of Drug Quality II, Center for Drug Evaluation and Research (CDER), FDA
Lunch
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesBreak
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesRisk management application in post-market safety & other PMSR Hot topics
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesLeading Facilitators: Khaudeja Bano, Vice President, Combination Product Quality, Amgen; Rich Wolf, Head of Pv Operations at CSL Behring
Facilitators: John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA; Fubin Wu, Co-founder, GessNet Safety Engineering; Kate Gillespie, Sr. Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson