The Westin Arlington

07 abr 2025 7:00 a.m. - 08 abr 2025 4:00 p.m.

801 N. Glebe Road, Arlington, VA 22203, USA

Global Labeling Conference

Join speakers from around the world sharing their labeling expertise!

Session 1: Last One Mile for e-labeling: Accelerating Health Innovation with e-labeling and Healthcare Interoperability

Session Chair(s)

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, International Labeling APAC

Pfizer R&D Japan G.K., Japan

Deborah  Bebbington

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
  • Gain insights into the progress of FHIR e-labeling initiatives worldwide
  • Identify industry preparation steps for the upcoming implementation of FHIR e-labeling
  • Discuss the utilization of e-labeling and healthcare interoperability for driving health innovation

Speaker(s)

Craig  Anderson

FHIR ePI Implementation: Present and Future Progress

Craig Anderson

Pfizer Inc , Canada

Director, R&D Labeling Lead, International Labeling

Juan  Garcia-Burgos, MD, PhD

How will ePI Enable Patient Centricity?

Juan Garcia-Burgos, MD, PhD

European Medicines Agency, Netherlands

Head of Public and Stakeholders Engagement Department

Rabi  Mohd, PharmD

Electronic Product Information · ePI

Rabi Mohd, PharmD

Jordan Food and Drug Administration, Jordan

IT Specialist · Drug Directorate

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