ICH Q12: A Paradigm Changing Guidance for Post-Approval Changes?
FDA, United States
ICH Q12 “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” has the potential to be a paradigm changing document for post-approval changes. The guideline provides new tools to streamline and harmonize processes for post approval changes, through introduction of “established conditions”, “post approval change management plans (PACMPs)”, and product lifecycle management (PLCM) documents. Speakers in this session will introduce the concepts included in the ICH Q12 draft document and provide forward looking thoughts on the potential utilization. Following, a panel of international regulators will discuss the implementation plans and challenges .
Learning Objective : Describe the elements for regulatory flexibility under ICH Q12 (e.g., established conditions, PACMPs) and their future potential for regulatory flexibility.