Workshop

Information about the 2026 Combination Products Summit pre-conference workshop will be announced soon. In the meantime, here are details from last year’s pre-conference workshop to help you better understand how we’ll tackle a vital issue.

details

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

This in-depth, interactive workshop will address some of the most vital issues impacting combination products today. Join us for an immersive dive into integrated combination product shelf life strategy, the latest combination products hot topics, and building a platform combination product.

Integrated Combination Product Shelf Life Strategy

Combination products such as autoinjectors sit at the intersection of pharmaceutical and medical device requirements, yet no single global guideline fully addresses their shelf-life strategy. While drug product constituents typically follow the requirements in ICH Q1A(R2) and device constituents often rely on approaches like ASTM F1980, manufacturers must bridge these frameworks to support a unified shelf life claim for the fully assembled combination product. This session will first clarify the “what” by outlining current expectations and regulatory considerations for each constituent. It will then move to the “how,” presenting practical case studies that demonstrate different, scientifically justified approaches to integrating drug and device stability strategies—highlighting how diverse methodologies can still meet regulatory intent while ensuring product quality and performance.

Hot Topics for Combination Products

Back by popular demand (again)! 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, platform strategies, and more.

Building a Platform Combination Product

Using concepts from recent industry papers and FDA guidance, attendees with apply these concepts to develop a platform device constituent package for CDER or CBER-led Combination Products. The workshop will be informed by a review of recent relevant guidance’s (bridging guidance, master file, platform designation etc.,) and guide participants in developing an approach to better qualify for any FDA regulatory relief program.

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.