Combination Products Summit 2025

Driving Engagement and Exploring Innovation for Combination Products

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Presented by

Presented by AFDO RAPS Healthcare Products Collaborative

Agenda

The Combination Products Strategic Committee is working diligently on the 2025 program line-up, carefully reviewing feedback from last year and suggestions provided as part of our open survey to the combination products community earlier this year. Their focus is to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. 

Here is just a glimpse of what you can expect in Providence this November!

Program Topics 

Global Harmonization in the Diverging Combination Products Space

EDDO Control Strategies 

Digital Health – Application of Good Machine Learning Practices

Clinical Investigations for Combined Use Systems (a global view)

Drug-Delivery Device Clinical Bridging: Leverage Platform Approach and Prior Knowledge

Navigating Human Factors for Combination Products (including Generic: URRA, Threshold Analysis and Post Market)

Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management

Challenges of Supplier and Partner Relationships

Clinical Strategies 

Lunchtime Table Topics

Hot Topics in Quality

Drug Delivery Systems: Home Use/Self-Administration Labeling Claims

Device-Led Combination Products

Cross-Labeled Products

Submissions

Please check back for additional session and speaker information to be announced soon.

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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