Integrated Process for Drug-Device Combination Products

This workshop provides an integrated view of the essential processes needed for the development of safe, effective, and reliable combination products. It encompasses Design Controls, Drug Development, Risk Management, Safety Assurance, and Reliability processes, highlighting their interrelations and dependencies. By incorporating this structured approach, organizations can improve efficiencies and reduce regulatory risks while ensuring safety and effectiveness. The complexity of drug-device combination products introduces unique challenges compared to standalone drugs or medical devices. Existing regulatory frameworks such as Quality by Design (QbD), design controls, and risk management were developed separately and may not fully address the integration required for combination products. This class will demonstrate how a holistic and structured approach enhances these frameworks to define, implement, verify, validate, and maintain product safety and effectiveness across the lifecycle.

This workshop will explore:

• The benefits of proactive modeling in streamlining the integrated approach to combination products, focusing on safety, reliability, and effectiveness.
• The role of digital traceability in QbD, design controls, risk management, and lifecycle management.
• How to effectively leverage the large amounts of data generated during testing and manufacturing to identify and refine specifications and integrate them into risk management processes.

Additionally, model-based systems engineering (MBSE) will be introduced as a digital framework to systematically manage safety- and effectiveness-critical functions, ensuring a proactive and data-driven approach to combination product development. Attendees will explore key concepts through a combination of lectures, real-world case studies, and hands-on activities, equipping them with practical strategies to address the unique challenges of combination products, navigate evolving regulatory expectations, and foster innovation while ensuring compliance.