Traditional regulatory submissions rely on static PDFs and manual processes, creating inefficiencies and risks. IQVIA highlights the shift to structured content, a versatile format defined by reusable components, semantic tags, and standardized schemas. This CORE (create once, repurpose everywhere) approach enables automatic generation of labeling, protocols, study reports, and post-market documents, improving efficiency and patient safety. Adoption is driven by regulatory demands and industry data standards but faces obstacles like change resistance, system integration, and training. A three-tiered change management model—understand, embed, adopt—helps organizations transition to component-based authoring.

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