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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 2 Track 2 - Optimizing Global Submissions

Session Chair(s)

Christian A. Buckley, MBA, RAC

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


Timm  Pauli

LEAN Dossier and Submission Management: Approaches to Process Optimization

Timm Pauli

PharmaLex , United States

Head of Regulatory Operations

Olga  Alfieri, MBA, MSc, RAC

Achieving Operational Excellence in the Global Regulatory Simultaneous Submissions Process

Olga Alfieri, MBA, MSc, RAC

Eisai Pharmaceuticals, United States

Senior Director, Global Submission Management & Operations

Mary  Gallagher, MS

Managing Global Submissions – From Identifying Core Content to What is Actually Submitted

Mary Gallagher, MS

Veeva, United States

Principal Consultant

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