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Regulatory Submissions, Information, and Document Management Forum

Session 9 Track 3: How to Utilize Systems and Technology as Document Enablers

    Session Chair(s)
      Jamie Marie Toth, MS

      Jamie Marie Toth, MS

      • Director/Head of TMF Operations
      • Daiichi Sankyo, Inc., United States
    This session will focus on utilizing technology within the EDMS space and the importance of applying business process, utilizing system vendors as partners, and having technology be a differentiator and improve interoperability.
    Learning Objective :

    At the conclusion of this session, participants should be able to:

  • Understand the importance of establishing business processes to drive EMDS configuration and implementation
  • Influence adoption of an EDMS through robust training and change management
  • Apply an infrastructure that supports continuous improvement for EMDS post-implementation
  • Understand the need for single-sources of truth beyond IDMP and text snippets used for auto-generated documents
  • Speaker(s)
      Cheryl A. Ressland

      Successful Business Process Driven EDMS Implementation in Less Than Nine Months

      Cheryl A. Ressland

      • Executve Director, Regulatory Operations
      • Daiichi Sankyo, United States
      Dalia  El-Sherif, DrSc, PhD


      Dalia El-Sherif, DrSc, PhD

      • Partner
      • Pyxa Solutions, United States
      Hans  van Bruggen, MSc

      Structured Content Management: Auto-Population and Auto-Generation of Documents at Roche

      Hans van Bruggen, MSc

      • Regulatory Affairs Scientist
      • eCTDconsultancy B.V., Netherlands
      Christina  Mantzioros , MS

      eTMF Interoperability: The Move Towards Content Portability

      Christina Mantzioros , MS

      • Clinical Solutions Specialist
      • Montrium, Inc., Canada