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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)

Andrew  Marr, PHD

Andrew Marr, PHD

Managing Director, Marr Consultancy Ltd, United Kingdom

Learning Objective : Discuss how you could approach IDMP from the angle of integration and convergence to ensure that your IDMP project will not become yet another silo, but the first stepping stone on a journey towards an integrated company, tying strings to the regulations; clinical trial regulation, ISO ICSR etc. Discuss potential benefits you can alleviate from IDMP.

Speaker(s)

Vada  Perkins, MS

Vada Perkins, MS

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States

FDA: Preparing for IDMP Implementation

Rune  Bergendorff, MSC

Rune Bergendorff, MSC

Partner, International Life Sciences, Implement Consulting Group, Denmark

IDMP: A Compliance Project or a New Way of Conducting Business?

William  Mandarino, MSC

William Mandarino, MSC

Associate Director, Product License Knowledge Management, UCB, Inc., United States

Strategies for Ensuring the Quality of the Data Needed to Support IDMP Compliance

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