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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 10 Track 1: Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools

Session Chair(s)

Nimesh  Patel

Nimesh Patel

Director of Global Regulatory Systems & Operations

Eisai Pharmaceuticals, United States

This session is a unique opportunity focused on the application of structured content authoring in the Life Sciences regulatory submissions. This presentation will highlight the latest EDM Structured Reference Model team developments, showcasing how their work influences industry-wide adoption. Gain valuable perspectives from two respected industry leaders who have successfully implemented this approach in their companies' regulatory processes. They will share their experiences, outline the challenges encountered, and discuss the practical benefits of structured content authoring.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Analyze Implementation Case Studies: Review real-life examples from industry leaders on integrating structured content authoring
  • Explore Benefits and Outcomes: Investigate the advantages and efficiencies achieved through structured content authoring
  • Apply Insights to Practice: Develop strategies to implement structured content authoring in your organization's regulatory submission workflow


David  Gwyn, MBA

DIA EDM Structured Reference Model: Empowering the Life Sciences Industry

David Gwyn, MBA

fme US, United States

VP, Business Consulting Services

Bettsy  Mayes

Harnessing the Power of Structured Content Authoring in your Submission

Bettsy Mayes

Roche - Genentech, United States

Product Manager - Document & Content Management

Gerald  Kukko

If Data-Centricity is the Answer to the Intelligent Submissions of the Future, Why is it so Hard to Achieve?

Gerald Kukko

Janssen, Canada

Information architect

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