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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)
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
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