Astrix Webinar – Data driven content – FHIR and the future of Regulatory Submissions

A webinar sponsored by Astrix 

Date: June 12, 2024

Time:  1:00 PM EST / 10:00 AM PST

Presented by:

Gabor Fari, Co-Founder and Principal, InteliNotion

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About this Webinar

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 (learn, discuss, etc.):

  • 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

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations.


Contact us today and let’s begin working on a solution for your most complex strategy, technology and staffing challenges.

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