Our ongoing project in combination product development has defined a rigorous data model that harmonizes risks and controls for quality, manufacturability, and safety. In combination product development, risk assessment processes are often independently executed, each following their respective compliance guidance. Device risk assessment teams are guided by ISO standards, and drug risk assessment teams are aligned with ICH guidelines. The intersection of “drug-device” leads to the risk of misalignment in the integrated control strategy for final products.

In this presentation, we elucidate our approach to define a data model supporting the structure and connections between different risk assessments to generate an integrated risk model. The model is designed to support updating and standardizing the data to fit specific outcomes.

Our approach enables teams to generate the Integrated Control Strategy and overall Product Risk Assessments, while proactively improving the overall risk mitigation actions throughout the lifecycle of the product.