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Session 2 Track 4 - The Strategic Challenges of Preparing for IDMP Implementation
Session Chair(s)
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.
Speaker(s)
Vada Perkins, MS
Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
FDA: Preparing for IDMP Implementation
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
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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