2026 Combination Products Summit

Driving Engagement and Exploring Innovation for Combination Products

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Presented by

Presented by AFDO RAPS Healthcare Products Collaborative
Combination Products Conference
Takes place November 17-18, 2026

Thank you for making Combination Products 2025 incredible!

Agenda

The Strategic Committee is working diligently on the 2026 program line-up to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities.  Here is a sneak peek at what to expect this November.

Preconference Workshop: Navigating Industry Trends: Hot Topics, Regulatory Best Practices, and Drug Delivery Strategies (Monday, November 16; additional fee required)

The Solutions Exchange: Talent and Organizational Structure for a Combination Products Organization

From the Desk of the Office of Combination Products – Strategic Priorities

Evolving European Union Legislation, Regulation, and Policy for Integral Drug-Device Combinations

Clinical Investigations for Combined Use Systems (2026 update)

The New Frontier: Evolving Pharma Capabilities for Standalone Devices

FDA and Industry Insights: QMSR Impacts on Combination Product Design, Development & Risk and How to Prepare for Compliance

Global Updates for Drug Delivery

Timely Changes: FDA Expectations and Industry Strategies for Combination Products

Digital Innovation integrated with advanced On-Body Drug Delivery Systems (OBDS)

10 Years Since US Combination Product cGMP Regulations: Reflections on Requirements, Expectations, and Enforcement

“The event was so valuable, as always. If I can only attend one event in a given year, this is the one that I prioritize.”

Roan Suzette

Suzette Roan

Associate VP, Head of GRA Devices, Sanofi

About 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 and the Regulatory Affairs Professionals Society. Learn more.

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© 2026 AFDO/RAPS Healthcare Products Collaborative