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Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 2: The Increasingly Critical Roles of RIM Systems and Their Expanding Number of Use Cases Beyond Regulatory Affairs

    Session Chair(s)
      Michiel  Stam

      Michiel Stam

      • Regulatory Information Scientist
      • eCTDconsultancy B.V., Netherlands
    RIM systems play an increasingly critical role in our organizations and their scope and use cases extend further beyond the Regulatory Affairs department. This session will focus on strategies and best practices for redefining and implementing RIM systems within today’s organization to successfully support a wide range of applications.
    Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand the increasing importance and roles of RIM systems within organizations
  • Provide solutions to address practical challenges of supporting different use cases for RIM simultaneously
  • Formulate a foundational RIM strategy
  • Speaker(s)
      Michiel  Stam

      Global Use Cases and Practical Challenges of Managing Regulatory Information from a Single Source of Truth

      Michiel Stam

      • Regulatory Information Scientist
      • eCTDconsultancy B.V., Netherlands
      Vahe  Ghahraman, PhD

      Foundational RIM Strategy for a Small to Medium-Size Enterprise

      Vahe Ghahraman, PhD

      • Sr. Director
      • Alexion Pharma, United States
      Sue  Metz

      Manage Change…Don’t Let Change Manage You

      Sue Metz

      • Vice President, Technical
      • PAREXEL International, United States