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Session 1: Last One Mile for e-labeling: Accelerating Health Innovation with e-labeling and Healthcare Interoperability
Session Chair(s)
Rie Matsui, RPh
Senior Director, Regional Labeling Head for APAC, International Labeling
Pfizer R&D Japan G.K., Japan
Deborah Bebbington
Head Global Labeling
Bayer Plc, United Kingdom
E-labeling initiatives have seen significant acceleration across regions with a focus on leveraging international common electronic standard to advance health innovation and enhance healthcare interoperability. In the US, FDA has developed SPL-FHIR Implementation Guide and is planning to implement FHIR e-labeling. Similarly, in the EU, the technical pilot for FHIR e-pi concluded in 2024, with its implementation currently in planning. Other regions, such as Jordan, have also made considerable progress in FHIR e-labeling adoption.
This session will provide a comprehensive update on the latest advancements in FHIR e-labeling initiatives for FDA SPL-FHIR and EMA’s e-pi implementations. Global progress in e-labeling adoption will also be explored, along with practical insights into what the industry needs to prepare for the FHIR e-labeling implementation. In addition, the session will discuss the broader applications e-labeling and healthcare interoperability to foster health innovation.
Learning Objective : - Describe the current status of FDA and EMA’s FHIR e-labeling initiatives
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Gain insights into the progress of FHIR e-labeling initiatives worldwide
- Identify industry preparation steps for the upcoming implementation of FHIR e-labeling
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Discuss the utilization of e-labeling and healthcare interoperability for driving health innovation
Speaker(s)
Speaker
Juan Garcia-Burgos, MD, PhD
European Medicines Agency, Netherlands
Head of Public and Stakeholders Engagement Department
Speaker
Moh'd Rabi
Jordan Food and Drug Administration, Jordan
ePI • Electronic Leaflet
Speaker
Craig Anderson
Pfizer Inc , Canada
Director, R&D Labeling Lead, International Labeling