ABSTRACT
The focus of this chapter is specifically on risk management for combination products and other combined use systems. The chapter begins with a high-level overview of risk management for medicinal products under ICH Q9(R1) and devices under ISO 14971:2019. The discussion then turns to an in depth review of integrated combination products risk management considerations, including: (i) key terminology as a basis for understanding; (ii) considerations for a successful cross-functional combination product Risk Management Team; (iii) and a review of a modular step-wise combination product risk management process including key expectations and best practices. The chapter also discusses considerations for use of third-party suppliers, and how to approach risk management for components/ constituent parts that were not developed under ISO 14971. Finally discussed are the possibilities for a drug-agnostic risk assessment approach to help drive efficiencies in development of medicinal-product-led combination products without compromising the critical proactive consideration of joint use of the differently regulated constituent parts. Throughout the chapter the authors underscore the critical connections between combination product development and post market risk management activities, to ensure safe and effective use of the combination product by intended users, for intended uses, in intended use environments.
