Planning for Success: Navigating Regulatory Strategy and Design Verification for Combination Products

The market for injectables has experienced consistent growth over the past decade, with projections indicating continued strong expansion. This trend is largely driven by the increasing number of drug approvals each year and the flourishing biologics sector. Similarly, the combination product market has surged significantly, fueled by the growing prevalence of chronic diseases, the demand for self-administered therapies, the popularity of minimally invasive procedures, and advancements in technology. The regulatory landscape for combination product development is dynamic, with regulators now possessing substantial expertise in this area. Consequently, there is an expectation that developers of combination products must thoroughly understand both the drug and device constituents, as well as the compatibility and performance of system-critical components when these elements are combined.

This webinar will delve into the intricacies of combination products and their regulatory approval pathways. It will outline regulatory expectations for combination product submissions, emphasizing risk-based determination, evaluation, and documentation approaches for performance requirements. Once a risk-based approach is established, the session will describe the Design Verification strategy. Additionally, practical examples will be discussed when developing and validating physical test methods to assess device performance.