Combination Products Conference

This session will explore end-to-end considerations for implementing post-market safety reporting (PMSR) requirements related to the inclusion of a device constituent part in a drug/biologic combination product. Speakers will discuss industry best practices to overcome key challenges (TPM, outsourcing of case processing, multiple presentations etc.) using a case study for a hypothetical device malfunction scenario in a single entity simple drug delivery system. Next they will outline a risk-based approach to handling device malfunctions, followed by a discussion on the challenges with lifecycle management. Next generation device development will be explored as we ask ourselves how are we doing in the development phase of combination products as an industry. The session will then conclude with Q&A including speakers from the FDA and EMA (EU) for audiences to gain insights on their objectives and plans for additional malfunction data collected in this process.