Whether the FDA designates your combination product a drug or a device, you need to understand – and follow – risk management requirements and standards for both. This presentation delves into the integration of ICH Q9(R1) and ISO 14971 for successful combination product risk management, including:

• The critical relationship between ICH Q9(R1) and ISO 14971:2019 in effective risk management for complex therapeutics.
• Key elements of and best practices for integrated drug and device risk management, including design controls, human factors, essential performance requirements, platform approaches and supplier considerations.