ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.
Learning Objectives
Explain the drivers, purpose, and plan for the ICH hosted PQKM Collaboration Platform in your organization; Describe the platform operating framework under ICH including goveranance and operation for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.
