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Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs , Astellas, United States
Learning Objective : - Understand the basics of LEAN principles - Apply LEAN principles on dossier and submission management process
Speaker(s)
Timm Pauli
Head of Regulatory Operations, PharmaLex , United States
LEAN Dossier and Submission Management: Approaches to Process Optimization
Olga Alfieri, MBA, MSC, RAC
Senior Director, Global Submission Management & Operations, Eisai Co., Ltd., United States
Achieving Operational Excellence in the Global Regulatory Simultaneous Submissions Process
Mary Gallagher, MS
Principal Consultant, Veeva, United States
Managing Global Submissions – From Identifying Core Content to What is Actually Submitted