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Regulatory Submissions, Information, and Document Management Forum


Session 9 Track 1: Critical Success Factors for Implementation of Regulatory Information Management Capabilities

    Session Chair(s)
      Venkatraman  Balasubramanian, PhD, MBA

      Venkatraman Balasubramanian, PhD, MBA

      • President and CEO
      • Cabeus, Inc., United States
    Changes to Regulatory Information Management (RIM) processes and systems must be in sync with frequent changes in global regulatory requirements, which to date are managed in silos using obsolete approaches. How can organizations leverage innovative approaches such as regulatory requirements as a service, where the knowledge base is provided as a service and is continuously maintained and updated? As organizations embark on transformational changes to their RIM systems, they must begin with a thorough understanding of business processes and requirements and focus on critical success factors such as business process transformation, organizational design, and change management, in addition to innovative technologies. As new systems are being planned and implemented, it is also important to leverage referential standards that are being derived from the efforts of IDMP such as Substances, Products, Organizations, Referentials (SPOR). These standards are going to become the basis for a single source of truth for authorized medicinal products and substances that can be reused across various regulatory processes. This session will have a reputed panel of experts sharing their views on how organizations must focus on critical success factors to transform the RIM landscape.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Understand how business process change, organizational design, and change management are key for successful RIM implementations
    • Review the impact of referential standards on design of a single source of truth around regulatory information
    • Understand emerging approaches such as regulatory requirements as a service could be leveraged more broadly
    Speaker(s)
      Venkatraman  Balasubramanian, PhD, MBA

      Regulatory Requirements: Content as a Service

      Venkatraman Balasubramanian, PhD, MBA

      • President and CEO
      • Cabeus, Inc., United States
      Kristen  Sauter, MBA

      Did the Emperor Forget His Clothes? Why Any Successful Technology or System Implementation Begins with Defining His Outfit

      Kristen Sauter, MBA

      • Director, R&D Consulting
      • Paragon Solutions, United States
      Remco  Munnik

      The Use of SPOR/IDMP and the Impact on Regulatory Affairs and RIM Solutions in the EU

      Remco Munnik

      • Regulatory Information Director
      • Asphalion S.L., Spain