返回 Agenda
Session 7, Track 3: Connect Regulatory Content from Source to Patient: Put FHIR and Structured Data Standards into Practice with Low-Cost Tools
Session Chair(s)
Karin Schneider, MLIS, MS
Associate Director, Johnson & Johnson, United States
Regulatory information remains fragmented across documents, systems, and functions, limiting content reuse, interoperability, and timely access to trusted information. This session explores how FHIR can provide a common structured data foundation for connecting and reusing pharmaceutical quality and electronic product information across submissions, labeling, and quality processes. Attendees will also see a practical, low-cost approach for transforming Word-based content into standards-based outputs using open-source scripting, metadata, APIs, and AI-assisted development. Finally, a German ePIL pilot demonstrates how FHIR-based product information can be delivered through health insurance apps, connecting authoritative regulatory content directly to patients.
Learning Objective : At the conclusion of this session, participants should be able to: - Explain how FHIR can connect PQ/CMC and ePI content for reuse across submissions, labeling, and quality processes
- Apply a low-cost, open-source method to transform Word content into standards-based structured data
- Evaluate a FHIR-based ePIL pilot and identify patient benefits and regulatory or policy implications
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