戻る Agenda
Pharmaceutical Quality Knowledge Management Platform Supporting Global Regulatory Assessment: Regulatory and Industry Perspectives for Translating Vision to Implementation
Session Chair(s)
David 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)
Industry Perspective
David Ross, MBA, MSc, PMP, RAC
AstraZeneca, United States
Senior Director, Digitial Advocacy and Policy
FDA Perspective
Ranjit Mathew Thomas, MBA
FDA, United States
Associate Director CDER
EMA Perspective
Hilmar Hamann, PhD
European Medicines Agency, Netherlands
Chief Information Officer
Health Canada Perspective
Marcin Boruk, MBA, MSc
Health Canada, Canada
acting Director, Business Facilitation and Modernization Directorate, Health Can