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Global Labeling Conference


Session 8: Labeling Process, Document Management Systems, and Databases

    Session Chair(s)
      Gerrit  Nijveldt, MSc

      Gerrit Nijveldt, MSc

      • Senior Director of Labeling
      • Sanofi US, United States
    Up-to-date data management systems are increasingly important to comply with SPL requirements in the US and IDMP in the EU, especially for the labeling function, which must look at the complete set of data needed for global and compliance. Labeling groups also frequently employ content authoring systems to consistently apply the data and updates in regulatory documents. This session will discuss the advantages and limitations of content authoring, its relation to data management, and the downstream use of systems that can integrate content and data as possible tracking tools for countries/affiliates.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Describe the concepts of content authoring for labeling
    • Identify advantages and limitations of content authoring for labeling
    • Discuss data needs and the importance of data management for labeling related data
    Speaker(s)
      Jun  Dong, PhD

      Speaker

      Jun Dong, PhD

      • Director, Business Partner for Global Regulatory Affairs and Development, R&D IT
      • Sanofi, United States
      Julie  Reitzinger

      Speaker

      Julie Reitzinger

      • Senior Director, Global Labeling and CCDS
      • Astellas Pharma, United States