PDA Metro Chapter Dinner: Risk Assessment & Management of Combination Product

Join the PDA Metro Chapter in an evening talk with Jon Cammack, who will highlight considerations in implementing a risk management process for combination products.

About this Event

Our evening's discussion will highlight considerations in implementing a risk management process for combination products.

The U.S. Food and Drug Administration (the FDA) terms therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another as combination products. Risk management, the iterative process of analyzing, evaluating, controlling, and monitoring risks, presents unique challenges for combination products. A fundamental characteristic of combo product risk management is addressing risks from the overall product or system, which necessitates assessment of risks contributed by constituent parts, their interactions, and how these risks interrelate.

Risk management activity for medical products, including combination products, relies on guidance from ISO 14971:2007 (Medical devices – Application of risk management to medical devices) , and ISO 24971:2013 (Medical devices – Guidance on the application of ISO 14971) (ISO 24971) and ICH Q9:2005 (International conference on harmonization of technical requirements for registration of pharmaceuticals for human use). The risk management continuum of planning, assessing, and controlling risks mirrors the same process for combination products as it does for individual drugs, biologics, and medical devices. The basic tenets of the risk management process include risk analysis, followed by risk assessment (an evaluation of the estimated risk related to harm). Based on the harm, risk controls (mitigation factors) are investigated, implemented and validated to ensure the controls function properly. Companies must then have some collation mechanism which captures the combination product's overall residual risk, risk/benefit analysis, and overall conclusion of the product's safety profile, which can be monitored and updated, according to on-going evaluation of relevant data and information.

Key Takeaways

At the end of this event you will have latest industry information available on best practices for risk management activity for combination products.