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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 9 Track 4: The Transformational Impact of FHIR on Regulatory Affairs Now and in the Future

Session Chair(s)

Cindy  Chiu

Cindy Chiu

Senior Director, Regulatory Affairs Operations and Quality Management

Merck & Co., Inc., United States

Modernizing information exchange between sponsors and regulators will unlock efficiencies, accelerate decision making, and provide a springboard for innovation. This session will provide a non-technical overview of how the exchange standard commonly used in the healthcare industry is being leveraged to transform exchange of regulatory information. HL7® FHIR® (Health Level 7 International’s Fast Healthcare Interoperability Resources standard) is a next-generation interoperability standard that can be used to exchange structured data and unstructured information. This session will focus on examining specific real-world implementation examples for using FHIR to support exchange of labeling, protocols, and CMC information across the biopharmaceutical industry. Speakers will present an overview of and demonstrate a modern method for exchanging and processing real-time medicinal product information using Health Level 7 International’s (HL7) Fast Healthcare Interoperability Resources (FHIR®) standard, application programming interfaces (API), and artificial intelligence (AI). Once in place, this new method of data exchange is expected to (1) improve efficiency by reducing the time and effort needed to manage regulatory information; (2) accelerate decision making; and (3) encourage innovation. Currently, the end-to-end timescale for the pharmaceutical regulatory workflow is measured in months and years. This new paradigm will use FHIR APIs and other supporting technologies to reduce the potential time for data exchange from months to days, hours, minutes, and eventually sub-seconds. With such drastic improvements in speed provided by digitization, automation, and interoperability, the biopharmaceutical industry can reach more patients, more quickly than at any time in the industry’s history. This session will focus on examining specific real-world implementation examples for using FHIR to support exchange of ePI and CMC information within and across the biopharmaceutical industry.

Learning Objective :
  • Describe HL7 FHIR in lay language, including commonalities and differences from other standards
  • Explain ways that FHIR is being used to advance the exchange of regulatory information
  • Access resources to further learn about this topic


Stacy  Tegan

What is HL7 FHIR and what does it have to do with Regulatory Information?

Stacy Tegan

Transcelerate Biopharma, Inc., United States

Program Director

Craig  Anderson

Preparing for a paradigm shift: The impact of FHIR, Real-time Data Exchange, and AI on labelling and CMC regulatory data

Craig Anderson

Pfizer Inc , Canada

Director, R&D Lead, International Labeling Group

G. Scott  Gordon, PhD

Future Benefits of Using FHIR for FDA Data Exchange

G. Scott Gordon, PhD

FDA, United States

Senior Health Informatics Officer, OSP, CDER

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