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Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation
Session Chair(s)
David C. Isom
Senior Director, Global Regulatory Policy and Intelligence, Global Product Devel
Pfizer Inc, United States
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 Objective : Explain the drivers, purpose, and plan for a global regulator-industry collaboration platform for PQKM; Describe the platform operating framework including governance and operation implications for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.
Speaker(s)
FDA Perspective
Representative Invited
FDA, United States
EMA Perspective
Representative Invited
European Medicines Agency, Netherlands
Health Canada Perspective
Representative Invited
Health Canada, Canada
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