Combination Products Summit 2025 to Convene November 13-14 in Providence, Rhode Island
York, Pa., January 21, 2025 — The AFDO/RAPS Healthcare Products Collaborative has opened registration for the Combination Products Summit 2025. Main conference sessions will be held at the Omni Providence in Providence, Rhode Island, from Thursday, November 13 to Friday, November 14. On Wednesday, November 12, there will be a full-day pre-conference workshop available for an additional fee and the availability for registrants to schedule one-on-one meetings with FDA’s Office of Combination Products staff during FDA Office Hours.Since 2015, the Combination Products Summit has united industry leaders and regulators for unparalleled collaboration. The event facilitates a welcoming setting for information sharing to drive a common understanding of key regulatory and quality concepts. The Summit also delivers an in-depth, interactive program that examines complexities and opportunities for actionable innovation to advance patient care.
“This isn’t your average summit. It’s a strategic gathering of industry and regulatory experts committed to advancing combination product safety and effectiveness through candid discussions that directly address complex challenges and drive practical, innovative solutions in our evolving environment,” said Kimberly Belsky, Combination Products Summit Strategic Facilitator. “The opportunity to connect and network with others creates an invaluable opportunity for collaboration that extends far beyond the session experience.”
The Combination Products Summit program is carefully curated by experts across the combination products community to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. The agenda is focused on inspiring collaboration, leading innovation, and making a difference across dynamic plenaries, including in-depth breakouts, updates from FDA, and the Solutions Exchange.
The Combination Products Summit 2025 Strategic Committee includes:
- Khaudeja Bano, Vice President, Global Head of Device Quality, Genentech/Roche
- James Bertram, Director, Office of Combination Products, FDA
- Fran DeGrazio, Principal Consultant, Strategic Parenteral Solutions
- Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie
- Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
- Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
- Hemal Mehta, Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products, Janssen Research & Development
- Susan Neadle, Principal Consultant & President, Combination Products Consulting
- Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green, P.C.
- Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly
- Tine Schroder-Albeck, Senior Quality Assurance Professional, ALK A/S
- Stephanie Shapley, Associate Director for Policy, Office of Combination Products, FDA
- Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck
- Chin-Wei Soo, Global Regulatory Head, Combination Products, Devices, Genentech
- James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, AbbVie
- Rich Wolf, Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance, CSL Behring
- Rumi Young, Director, Regulatory Policy, Novo Nordisk
###
About the AFDO/RAPS Healthcare Products Collaborative
The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS). The Collaborative supports idea sharing, innovation, and action across the global healthcare products community by fostering purpose-driven discussions among regulators, industry, academia, and thought leaders about the most pressing issues facing the industry. Our distinct events portfolio, which includes the MedCon Conference and Combination Products Summit, highlights just one of the ways we inspire collaboration. This unique blend of mission and values guides purpose-driven community building and innovative solutions to make a difference in patients’ lives. www.healthcareproducts.org
