ePI on FHIR: Shaping the Future of Global Healthcare – Part 3
Key takeaways from this session
ePI is becoming a regulatory reality: With new EU pharmaceutical legislation, including the European Health Data Space, ePI is set to become mandatory from 2026, marking a major shift from voluntary adoption to a core regulatory requirement.
FHIR is the foundation: ePI is more than a “simplified summary,” it is full, authorised product information structured in HL7 FHIR, enabling machine-readability, real-time updates, and seamless interoperability with future EHDS-compliant EHR systems.
From pilot to implementation: The EMA/HMA pilot demonstrated that ePI can be successfully created and published in real regulatory procedures, with APIs enabling access to trusted content across digital health platforms. Implementation showed that “step-by-step beats ‘big bang.’” Progress towards patient-friendly ePI should be systematic, while preserving easy access to the complete, original source of information.
Towards a digital medicines ecosystem: ePI will play a key role in linking medicines information with ePrescriptions, EHRs, and cross-border health services, supporting safer and more informed care. ePI is expected to transform how people use medicines, and the benefits after implementation remain largely open to further research and innovation.
Gravitate Health impact: The project showcased how ePI can be transformed into personalized, patient-friendly information using approaches like G-lens®, improving understanding, accessibility, and adherence.
It takes a community of stakeholders to develop and implement ePI. Developing and implementing ePI cannot be done by regulators and industry alone. Through Gravitate Health, an ePI stakeholder community has been established, showing how structured collaboration across stakeholders can unlock new opportunities for patient-friendly and personalised electronic medicinal product information.
Looking ahead: The launch of the Gravitate Centre for Trusted Health Information signals a strong commitment to sustaining and scaling this work beyond the project lifecycle. It is an open invitation to keep collaborating. Stakeholders are encouraged to continue working together, exploring new use cases and stay connected with Gravitate Health as a driving force in this evolving ePI community—and beyond the project into the next steps with the “Centre.”
It’s clear that ePI is a foundational step toward a fully digital, interoperable EU medicines ecosystem, transforming how product information is created, managed, and used to empower patients and healthcare professionals alike.
Recording available
If you missed the live event, the recording for the concluding session of this series is now available, together with speakers’ presentations.
A stellar lineup of speakers from Gravitate Health and collaborating organisations keeps you at the forefront of ePI innovation and the evolving European health data landscape.
Key takeaways from this session
- Trusted medicine information should be available in digital health environments.
- Developing ePI requires strong collaboration between regulators and stakeholders.
- Successful implementation depends on integration with national health systems.
agenda
- Welcome, Agenda & Introductions – Mrs Ronnie Mundair, Senior Director, GRS, Pfizer
- Strengthening FIFARMA’s commitment to healthcare – Mrs Yaneth Giha, Executive Director, FIFARMA
- LATAM ePI Playbook – Mr Diego Salas, Director, FIFARMA
- An update from Gravitate-Health – Prof. Anne Moen, Academic Coordinator, University of Oslo
- Advancing the National ePI Journey through Gravitate Health: An NCA perspective – Dr Erol Hofmans, Innovation Advisor, MEB
- FHIR ePI and the impact on global digital labeling strategies – Mr Craig Anderson, Business Product Director, J&J
- Closing Remarks – Mr Leonardo Semprun, Global Regulatory Policy Lead LatAm MSD & FIFARMA Regulatory Group Co-Chair
AGENDA & TOPICS
- General introductions and a Summary of key ePI global developments, Rie Matsui, APAC e-labeling EWG leader; Senior Director and Regional Labeling Head for APAC, Pfizer R&D Japan, & Anne Moen, Coordinator, Gravitate Health; Professor, University of Oslo, Norway
- Introduction to Gravitate Health, Giovanna Ferrari, Project Lead, Gravitate Health; Senior Director and Regional Labeling Head, Pfizer
- EMA – a regulators’ perspective (EU) and lessons learned from ePI pilot, Elizabeth Scanlan, ePI Product Owner, European Medicines Agency
- Jordan – a regulators’ perspective (Middle East) and demo of ePI system/app, Mohd. Rabi, IT Specialist, Drug Directorate, JFDA
- Taiwan – a regulator’s perspective (APAC) and future plans for e-labeling introduction, Chi Chung, Section Chief, TFDA
- Compendia – Felleskatalogen’s 20-year journey towards electronic product information (ePI) in Norway, Bente By Jansen, Managing director, Felleskatalogen AS
Panel Discussion & Q&A
The event concluded with a panel discussion, where attendees engaged with the speakers and asked questions about ePI’s potential in transforming global healthcare systems.
SESSION AGENDA
The Agenda featuring expert speakers is now announced:
- Introduction – Ronnie Mundair, Senior Director, GRS, Pfizer
- EU General Pharma Registration (GPL) Update – Dr Petra Wilson, Senior Advisor EU Policy, HIMSS; Ethical-Legal Lead, Gravitate Health
- ePI roadmap: pathway to implementation for EU medicines – Dr Juan Garcia Burgos, Head of Public and Stakeholders Engagement Department, European Medicines Agency
- The road to ePI implementation, an NCA update – Evinn Drusys, E-labeling developer, AEMPS
- Gravitate Health close of project update – highlights and achievements – Dr Giovanna Ferrari, Regional Labeling Lead, International Labeling, Pfizer; Project lead
- From Vision to Implementation of ePI – Industry Reflections – Dr Koen Nauwelaerts, Regulatory Policy and Innovation Lead, Bayer AG
- Gravitate Health Next Steps; future sustainability actions – Dr Anne Moen, Academic Coordinator, University of Oslo
- Closing remarks – Dr Juan Garcia Burgos & Dr. Anne Moen
EVENT HIGHLIGHTS
WHEN? May 6, 2026
Time:
14:00–15:30 CET | 13:00–14:30 BST
WHERE? Virtual
ePI is on FHIR around the Globe – Past Webinars
This event builds on the insights from Gravitate Health’s two previous virtual events: ePI on FHIR – Part I, held in October 2024, and co-hosted with the Asia Partnership Conference of Pharmaceutical Associations (APAC); ePI on FHIR – Part II, held in March 2026, in partnership with FIFARMA, the Latin American Federation of the Pharmaceutical Industry.
