Learn About the Latest Regulatory Advancements in Combination Products with a Focus on Risk Management

This session will engage an expert panel in a discussion on a number of timely regulatory policy topics for drug-device combination products. FDA is set to issue new guidance on human factors, essential performance requirements (EPRs), and bridging, which will impact combination product reviews and risk management. There have been a number of recent developments in Europe, as MDR continues to be implemented. In addition, there has been recent harmonization work on ICH Q9(R1) for quality risk management that has the ability to impact risk management practices for both the drug and device constituent parts, especially in the areas of product availability risk and supply chain control.

Medical device manufacturers, pharmaceutical sponsors, and regulators will discuss these recent developments.