"Streamlined" Risk Management for Drug-Device Combination Products

A combination product is one that is comprised of two or more different types of medical products- e.g., a drug and a device, a biological product and a device, or a drug/biological product/device -  that must be physically, chemically or otherwise combined or mixed to achieve their intended use/therapeutic effect.  This presentation addresses risks specific to combination products (CP), and how to apply a “streamlined” risk management process, integrating  ISO 14971 and ICH Q9, to combination products across the total product lifecycle.  This presentation is intended to provide recommendations on best practices, recognizing that risk management requirements might vary across regulatory jurisdictions.  A fundamental aspect of this highlights the importance of assessment of risks contributed by components, constituent parts, their interactions and how these risks interrelate.   The streamlined framework can be applied for the combination product even if other paradigms are applied to its constituent parts.

Key elements of this presentation include:

• Emphasis on the importance of risk management planning, providing details on the planning phase and on how to ensure applicable considerations are addressed during appropriate lifecycle phases for combination product components, constituent parts and the drug-device system as a whole.

• Application of a “streamlined” risk management approach, integrating (1) applicable ICH Q9 outputs [characteristics related to the drug or biologic] and (2) applicable ISO 14971 outputs (medical device and use-related characteristics) into an integrated 14971/ICH Q9 risk management framework.

• Examples to help illustrate and elucidate the concepts addressed.