IH08 - How can marketing authorisation holders best prepare for ePI – a view from the perspective of a global content service provider

The pharmaceutical industry faces increasing complexity in managing multilingual regulatory content, patient information, labelling, and safety communications. The HL7 FHIR (Fast Healthcare Interoperability Resources) standard—originally created to streamline health data exchange—offers a powerful framework to improve language management across the lifecycle of a medicinal product.

FHIR’s modular, structured resources enable organizations to store, model, and transmit electronic product information (ePI) in a consistent and machine-readable way. By embedding linguistically relevant metadata FHIR supports automation in translation workflows and ensures global consistency of regulated documents.

This presentation will demonstrate how a workflow like this can be built end to end—starting from unstructured content, converting to structured FHIR content and flowing through translation, quality checks and multilingual output generation. The practical benefits of using FHIR as the backbone for global language operations are clear, and the opportunities for growth and advancement are limitless.