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Global Harmonization: Mutual Recognition
Session Chair(s)
Roger Nosal, PhD
Vice President, Head of Global CMC
Pfizer Inc, United States
Despite efforts to harmonize regulatory requirements, the proliferation of divergent expectations continues to unnecessarily complicate management of product supply chains. While divergent regulatory requirements are largely the result of local economic drivers, the impact on regulatory approvals, inspections, change management and inventory limits continuous improvement and optimization of manufacturing and is ultimately challenging for industry and regulatory authorities globally.
Learning Objective : Discuss the challenges of global harmonization on the management of the product supply chain
Speaker(s)
EU-FDA Mutual Recognition Agreement for GMP Inspections
Niraj Mehta, PhD
FDA, United States
Associate Director for Global Regulatory Policy, GO, OC
Industry Perspective
Chi-Wan Chen, PhD
Pfizer, Inc., United States
Postapproval Change Management Protocols: Future Opportunities
Terrance Ocheltree, PhD, RPh
Corium, Inc., United States
VP, Head of Regulatory Affairs and Quality Assurance
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