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Session 7, Track 3: FHIR-Based ePI: From Process and Creation to Patient Distribution
Session Chair(s)
Karin Schneider, MLIS, MS
Associate Director, Johnson & Johnson, United States
Session 7, Track 3: FHIR-Based ePI: From Process and Creation to Patient Distribution
Learning Objective : 1) Explain how HL7 FHIR structures Pharmaceutical Quality (CMC) and ePI content within one interoperable data model. 2) Identify ways to reuse FHIR-based content across submissions, labeling, and quality documentation. 3) Compare how organizations define, hold, and trace PQ/CMC and ePI data elements, and identify where data lineage gaps exist.
Speaker(s)
FHIR for Pharmaceutical Quality and ePI: Building Interoperable, Reusable Regulatory Content
Joan Cheung, PharmD, RPh
Principal Consultant, Epista Life Science, United States
Mock Connectathon: Connecting Structured Content and Structured Data Using Industry Standards (USDM, EPI, Others)
John Jones, MBA
SVP, Consulting, Entitech, A Tandym Company, United States
Integrating ePIL into Statutory Health Insurance Apps Using FHIR globally
Paul Kamm
Product Owner Patient Solutions, Rote Liste Service GmbH (cormeo GmbH), Germany
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