Applying ICH Q12 to Combination Products

09:30 - 10:05

With the anticipation of ICH Q12 guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management proceeding to Step 4 in late 2019, combination product sponsors have an opportunity to level set expectations on CMC life cycle management as well as to improve the CMC submission strategy and dossier. Perspectives on how ICH Q12 can be implemented for drug-device combination products will be discussed with a focus on the device constituent. Additionally, current thinking on the use of Established Conditions to create a performance-based device constituent control strategy will be shared.

Diane Harper, Director Regulatory Affairs-CMC, Merck