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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)
LEAN Dossier and Submission Management: Approaches to Process Optimization
Timm Pauli
PharmaLex , United States
Head of Regulatory Operations
Achieving Operational Excellence in the Global Regulatory Simultaneous Submissions Process
Olga Alfieri, MBA, MSc, RAC
Eisai Co., Ltd., United States
Senior Director, Global Submission Management & Operations
Managing Global Submissions – From Identifying Core Content to What is Actually Submitted
Mary Gallagher, MS
Veeva, United States
Principal Consultant