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Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 4 Track 4 - Structured Authoring – New Paradigm for Data Driven Authoring for Life Sciences

    Session Chair(s)
      Jake  Doran

      Jake Doran

      • Chief Technology Officer
      • Genpact Pharmalink, United States
    Structured authoring isn’t something new, but is the life sciences industry now ready to adopt the concept and implement the vision to realize the strategic advantage? Examine compelling information around the concept of structured authoring, how structured authoring has developed over the years, and how a comprehensive enterprise approach to Structured Content Management (SCM) can be leveraged by your organization to streamline the process of developing submission information. Learn how SCM can be utilized to facilitate information and document re-use and ensure accuracy of information throughout the life cycle of product development. Hear from subject matter experts on the concept and from an industry representative on the journey one organization is taking to realizing the future of document authoring.
    Learning Objective : The shift from submission to product focus is already happening. We are forced to think in Product Information entities rather than in documents and structures. The border between data and content disappears. Identify the overlapping and complementary areas between Master Data principles and Regulatory Information Management requirements. Enable automated data governance.
      Romuald  Braun, MSc

      Structured Authoring - New Paradigm for Data Driven Authoring for Life Sciences?

      Romuald Braun, MSc

      • Vice President, Strategy - Life Sciences
      • AMPLEXOR, United States
      Jim  Nichols

      An Information Architecture Designed for Reusability: Avoiding Tiny Topic Syndrome

      Jim Nichols

      • Chief Operations Officer
      • Cunesoft Inc., United States
      Frank J. Meloni, PhD

      Building the Business Case for Adopting a Structured Authoring Toolkit: What Does it Take and Why is the Process so Painful?

      Frank J. Meloni, PhD

      • Director
      • Janssen Research and Development, LLC, United States

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