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2016 年 02 月 08 日 12:00 下午 - 2016 年 02 月 10 日 5:15 下午

Regulatory Submissions, Information, and Document Management Forum

Session Chair(s)

Christian A. Buckley, MBA, RAC

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

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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