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Session 2 Track 2 - Optimizing Global Submissions
Session Chair(s)
Christian A. Buckley, MBA, RAC
Associate Director, Regulatory Affairs
Astellas, United States
As the global business environment becomes increasingly competitive and complex, regulatory teams are increasingly challenged to contribute to the acceleration of the drug approval and maintenance process. It is critical that companies ensure an uninterrupted and “first time right” flow of regulatory information that starts from submission document creation. We will discuss lean critical thinking needed to optimize an end-to-end process for global filing strategies based on lessons learned; including a growing trend to implement core regulatory dossiers for use by affiliates to create local submissions.
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