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Regulatory Submissions, Information, and Document Management Forum


Session 7 Track 1: Paradigm Shift in Data Management and How to Enrich Business Intelligence to Benefit the Industry

    Session Chair(s)
      Brooke  Casselberry, MS, RAC

      Brooke Casselberry, MS, RAC

      • Owner
      • Cyan Life Sciences, United States
    This session cover case studies from three top biopharmaceutical companies and how they are changing the way they use data in their organizations. You will learn how organizations are using data and standards in more expansive ways. You will hear directly from peers on the steps taken to change the current thinking in their organizations on data, RIM, IDMP, and overall standards.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Learn how organizations are using data and standards in more expansive ways
    • Hear directly from peers on the steps taken to change the current thinking in their organizations on data, RIM, IDMP, and overall standards
    • Discuss how to change their system, data, and user interface approach from being an administrative activity to an analytical activity
    Speaker(s)
      Kelly  Hnat

      Case Study – Implementing a Paradigm Shift in RIM Data Management: From Administrative Afterthought to Strategic Asset

      Kelly Hnat

      • Sr. Director, RIM
      • Teva, United States
      Andrea  Herrmann

      Case Study – Improvement of Collaboration Across Industries

      Andrea Herrmann

      • Director, Strategy Implementation Leader
      • Merck KGaA, Germany
      John  Stanek

      Case Study – Enhanced Planning for Due Diligence and M&A Using the ISO IDMP Data Model

      John Stanek

      • Sr. Associate, Global Regulatory Affairs
      • Johnson & Johnson Group of Consumer Companies, United States