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Bethesda North Marriott Hotel and Conference Center

Feb 02, 2026 10:00 AM - Feb 04, 2026 12:45 PM

5701 Marinelli Road, North Bethesda, MD 20852

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)!

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Case Study Sponsored by InteliNotion LLC

Session Chair(s)

Sponsored Sessions

Sponsored Sessions

United States

Generative AI (GenAI) has emerged as a transformative technology for innovation in the medical writing space, offering unprecedented opportunities for growth and efficiency. However, amidst the excitement, key challenges must be addressed, including implementation in a regulated environment, ensuring compliance and governance, managing the proliferation of diverse language models, maintaining human oversight and intervention. This comprehensive case study is an update from last year’s presentation and chronicles the continuing journey of a leading global biopharmaceutical company as it leverages GenAI and Structured Component Authoring (SCA), addressing the complexities and opportunities in medical writing, and pioneering a path to Intelligent Content creation.

Featured Topics:

  • Implementation Strategy: Best practices for integrating GenAI with Componentized Content in a regulated environment
  • Harnessing the power of a combined GenAI/SCA system: Determining where to leverage the benefits of SCA’s structured governance vs. precise content generation from agent-driven GenAI technology
  • Precision Prompting: How to craft prompts and evaluate generated outputs
  • Content Structure and Governance: Enhance content compliance and quality through effective organization and architecture
  • Automated Authoring: opportunities for implementing automated processes to drastically reduce the time it takes to generate key documents like CSRs, while increasing throughput and quality
  • Content Transformation and Reuse: Maximize efficiency through reuse and adaptation across diverse document types

    • Speaker(s)

    Matthew Renda, PHD, MS

    GenAI in a Global Biopharmaceuticals Company – Progress Update

    Matthew Renda, PHD, MS

    Alexion, Astrazeneca Rare Disease, United States

    Senior Director Medical Writing Operations

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