• Akm Khairuzzaman Ph.D.

Proposal Description:

There is currently a lack of a harmonized approach on technical and regulatory considerations for lifecycle management. While the concepts in ICH Q8, Q9, Q10, and Q11 provide opportunities for a more science and risk-based approach for assessing changes across the lifecycle, several gaps exist that limit full realization of intended benefits. The envisioned post-approval "operational flexibility" has not been achieved. The main emphasis at ICH to date has focused on early stages of the product lifecycle (i.e., development through launch). A similar focus is now needed for the commercial manufacturing phase in order to fill the gaps in the implementation and fully realize the opportunities promised by ICH Q8 to Q11. Post-approval change management plans and comparability protocols offer the flexibility to reduce the reporting category. This session will provide an overview of the flexible change management pathways and provide examples of when these have been utilized in small molecules and biologics.