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Session 10 Track 1: Leveraging Structured Content Authoring in Regulatory Submissions: Real-World Experience, Industry Insights and Tools
Session Chair(s)
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
Speaker(s)
DIA EDM Structured Reference Model: Empowering the Life Sciences Industry
David Gwyn, MBA
fme US, United States
VP, Business Consulting Services
Harnessing the Power of Structured Content Authoring in your Submission
Bettsy Mayes
Roche - Genentech, United States
Product Manager - Document & Content Management
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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