Workshop

2025 Pre-Conference Workshop

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

This Pre-Summit Workshop will address 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! Come join in the fun and engage with a panel of combination product regulatory experts from across industry as they share approaches, strategies, and case studies on key regulatory topics. This will be a lively, interactive, and collaborative session. The discussion will target 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 aims 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 will include 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 may include the use of third-party drug delivery systems and leveraging platform drug delivery technologies.

Feedback from this workshop will aid 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In June 2024 the FDA released a draft guidance on Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. The draft guidance describes Agency expectations for essential drug delivery characteristics for certain medical devices and combination products and articulates an approach to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 seeks to better understand how industry has interpreted key concepts in the guidance and explore how these concepts can be integrated into existing development, post-approval and global regulatory processes.

Each session explores important issues and approaches on dealing with combination products. Participants will increase their knowledge and diversify their learning!

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