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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 4 - The Strategic Challenges of Preparing for IDMP Implementation

Session Chair(s)

Andrew  Marr, PhD

Andrew Marr, PhD

Managing Director

Marr Consultancy Ltd, United Kingdom

With the upcoming deadlines in Europe of the implementation of IDMP, regulators and industry are gearing themselves up in readiness. This session will address the latest status of regulators plans and how industry can address the challenges and opportunities of defining and moving programs forward.

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.


Vada A. Perkins, DrSc, MSc

FDA: Preparing for IDMP Implementation

Vada A. Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

Rune  Bergendorff, MSc

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

Rune Bergendorff, MSc

Implement Consulting Group, Denmark

Partner, International Life Sciences

William  Mandarino, MSc

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

William Mandarino, MSc

UCB, Inc., United States

Associate Director, Product License Knowledge Management

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