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Session Chair(s)
Georges L. France, PHARMD
VP, LOCs Global QA Head
GSK CH, Switzerland
Speaker(s)
Introduction: Challenges and Opportunity from New Quality Paradigm
Georges L. France, PHARMD
GSK CH, Switzerland
VP, LOCs Global QA Head
CTD Document and New Quality Paradigm
Jean-Louis Robert, PHD
Luxembourg
Former CHMP/CVMP QWP Chair
Process Validation
Catherine McHugh
Irish Medicines Board, Ireland
Executive Pharmaceutical Assessor
Post Approval Management and Change Control
Michael J. James, PHD, MSC
GlaxoSmithKline R&D, United Kingdom
Director of CMC Regulatory Advocacy and Intelligence