Structured content authoring

2:15 PM - 2:30 PM

Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with free-form text, figures, and tables that the medical writer can arrange in any configuration. By structuring and standardising clinical and regulatory content, the pharmaceutical industry can shift from a document-based to a content-based approach. This transition will require adopting structured content management tools and standardising content. In the long term, implementation of structured content authoring will lay a framework for automation of clinical and regulatory documents. In tandem, medical writers must evolve their skill set and ways of working, primarily through planning and producing content, and adopting structured content authoring practices to facilitate content creation and re-use. The purpose of the symposium presentation is to introduce structured content authoring and highlight how the medical writing role in the pharmaceutical industry may soon evolve.