Workshop

View the 2025 Pre-Conference Workshop topics below to see what was covered.

Navigating Industry Trends: Hot Topics, Regulatory Best Practices, and Drug Delivery Strategies

This Pre-Summit Workshop addressed current and emerging hot topics impacting the industry, best practices for optimizing combination product regulatory submissions and development programs, and strategies for establishing drug delivery performance (e.g. essential drug delivery outputs).

Hot Topics for Combination Products

Back by popular demand! Attendees engaged with a panel of combination product regulatory experts from across industry as they shared approaches, strategies, and case studies on key regulatory topics. This was a lively, interactive, and collaborative session. The discussion targeted a range of topics including CP development and submission strategy from clinical to post-market, including strategies and approaches related to clinical studies, clinical bridging, phase appropriate testing, human factors, post-approval changes, control strategies, and more.

Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions

This interactive and collaborative workshop aimed to identify and address common mistakes and challenges faced by sponsors, regulators, and conformity assessment bodies (e.g., Notified Bodies) in combination product submissions. It included a discussion on best practices and lessons learned for optimizing communication and engagement between sponsors and regulatory bodies, engagement pathways, responding to deficiencies and information requests, and pitfalls in structuring and organizing complex regulatory submissions. Such considerations included the use of third-party drug delivery systems and leveraging platform drug delivery technologies.

Feedback from this workshop aided in developing a best practices discussion paper on combination product submissions, which will serve as a resource guide for stakeholders.

Essential Drug Delivery Output

In June 2024 the FDA released a draft guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. The draft guidance describes Agency expectations for essential drug delivery characteristics for certain medical devices and combination products and articulates an approach to identify and submit this information for FDA review. This session sought to better understand how industry interpreted key concepts in the guidance and explored how these concepts could be integrated into existing development, post-approval and global regulatory processes.

Each session explored important issues and approaches on dealing with combination products. Participants increased their knowledge and diversified their learning!

Please note – this workshop requires a separate registration fee and is not part of the main Summit.