Combination Products Summit Workshop
Explore the 2023 workshop topics below.
Notified 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: Timothy Chesworth, Senior Director Regulatory Affairs - Devices & Digital Therapeutic, AstraZeneca; 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 QA – Global Quality Devices, ALK A/S
Facilitators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Rick Wedge, Associate Research Fellow, Pfizer; Milind Ganjawala, 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, VP 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; Dan Wozinski, Device Expert, Center of Device Excellence, Sanofi