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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)

Jake  Doran

Jake Doran

Head of Digital

Lykos Therapeutics, United States

Learning Objective : The shift from submission to product focus is already happening. We are forced to think in Product Information entities rather than in documents and structures. The border between data and content disappears. Identify the overlapping and complementary areas between Master Data principles and Regulatory Information Management requirements. Enable automated data governance.

Speaker(s)

Romuald  Braun, MS, MSc, RAC

Structured Authoring - New Paradigm for Data Driven Authoring for Life Sciences?

Romuald Braun, MS, MSc, RAC

Uanotau Gmbh, Switzerland

Managing Director

James  Nichols

An Information Architecture Designed for Reusability: Avoiding Tiny Topic Syndrome

James Nichols

Phlexglobal - Now Cencora Pharmalex, United States

Chief Product Officer

Frank J. Meloni, PhD

Building the Business Case for Adopting a Structured Authoring Toolkit: What Does it Take and Why is the Process so Painful?

Frank J. Meloni, PhD

Janssen Research and Development, LLC, United States

Director

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