IH03 - How AI-enabled Structured Content Authoring is transforming documentation across Regulatory and Drug Development use cases
Information
This session will explain how AI-enabled Structured Content Authoring is transforming the landscape for documentation across Drug Development and Regulatory use cases.
Until now, Regulatory Documentation has been created, reviewed, published and managed in static document formats, including word processor formats and PDF. The processes to author, review and publish information stored this way are slow, costly, and lack scalability. This also results in content that’s less optimized for use in digital formats including XML, JSON or HL7 FHIR, and not optimized for AI-based approaches.
Learn how intelligent and structured content authoring powered by an end-to-end content management platform can change all that by creating and leveraging components, which are Findable, Accessible, Interoperable and Reusable (FAIR) across key business areas:
- Chemistry, Manufacturing and Controls (CMC) or Module 3 of the CTD
- Labelling, including ePI and eLabelling
- Clinical use cases including Study Protocols, Informed Consent, and other operational documentation
Narrative content that has been optimally componentized and curated also improves the performance and accuracy of Generative AI-based approaches, while making sure that GenAI approaches can be safely used in GxP-validated contexts.
