CMC Workshop

Session Chair(s)

Combination products represent a unique intersection of drug product and device regulation. Determining how and when to apply the diverse regulations in the design, development, registration, and maintenance of these products is something every Combination Product sponsor needs to consider. This session will include:

• Regulatory challenges that combination product sponsors commonly face for existing device constituents, such as a change in resin type, a new raw material supplier, or changes to part molds, and how Established Conditions can be used to improve submission strategy and the dossier.
• The challenges of combination products from the device engineer perspective when developing delivery systems for generic and complex generic drug products including an examination of complying with Combination Products GMP Design Control regulations, determining Design Inputs and Essential Performance Requirements, identifying and addressing Threshold Analysis, Human Factors and Risk Management requirements.
• The key principles of risk management that apply to combination products and the tools available to perform risk management including examples of the challenges drug companies face when applying these tools. Additional examples will be provided showing how risk management findings are connected to Essential Performance Requirements and reliability.

Speaker(s)