The Westin Arlington

2025年4月07日 (月) 午前 7:00 - 2025年4月08日 (火) 午後 4:00

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

Global Labeling Conference

Join speakers from around the world sharing their labeling expertise!

Registration Ends

21

DAYS

21

HOURS

05

MINUTES

04

SECONDS

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, Regional Labeling Head for APAC, International Labeling

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)

Juan  Garcia-Burgos, MD, PhD

Speaker

Juan Garcia-Burgos, MD, PhD

European Medicines Agency, Netherlands

Head of Public and Stakeholders Engagement Department

Moh'd  Rabi

Speaker

Moh'd Rabi

Jordan Food and Drug Administration, Jordan

ePI • Electronic Leaflet

Craig  Anderson

Speaker

Craig Anderson

Pfizer Inc , Canada

Director, R&D Labeling Lead, International Labeling

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