Overview

The shift to structured content and data has been a long-term objective for regulatory agencies and the Biopharma industry. However, progress has been hampered by a lack of open and broadly adopted industry standards and tools. While the Electronic Common Technical Document (eCTD) is a widely adopted standard for regulatory submissions, it only uses XML as the structural backbone for the submissions package and to handle metadata, the content itself is still largely made up of unstructured documents. However, there is a commonly used standard for exchanging health information that is being adopted that could change the landscape over the next several years: FHIR (Fast Healthcare Interoperability Resources) is a widely used application programming interface (API) focused standard used to represent and exchange health information maintained by the standards development organization HL7 (Health Level 7). There are several important Pharma initiatives that are already based on FHIR: the EMA ePI Labeling standard, the FDA PQ/CMC initiative, and the ICH M11 Protocol template initiative, with others to follow.

In this webinar, we will explore

• What is the FHIR standard?
• The transformational potential of FHIR
• How will legacy regulatory systems and processes adopt FHIR?
• What about legacy content formats? The opportunity for coexistence.