European common standard for electronic product information (ePI) at DIA Europe 2022
The Gravitate Health IMI project (2020 – 2025) will develop the G-Lens to capitalize on opportunities provided by digitalization of regulator approved medicine information (ePI) to give patients ’focused medication information in their preferred modality, context, and at the right time’. The project seeks to present focused ePI information using the patient’s profile of combined EHR information, personal preferences and context of use. Gravitate Health will develop an open-source platform with state of the art interoperability standards to deliver a G-lens with a set of rules to process, present and communicate reliable, relevant, understandable, and actionable information.
Anne Moen will present the Project mission and first outputs as an introduction to this session. Lubos Michalov, a member of the Gravitate Health User Advisory Group will explain why Gravitate Health matters from the patient perspective. Juan Garcia-Burgos, EMA, will speak on the “Electronic product information (ePI): towards harmonised implementation in the EU” and Catherine Chronaki, HL7 Europe, will present “The role of standards in delivering ePI”. A panel discussion with Q&A will follow to discuss synergies and initiatives involving Gravitate Health and ePI, moderated by Giovanna Ferrari.
The “Regulatory Operations” Track at DIA Europe 2022 also features other interesting sessions on Wednesday, March 30th, such as:
“European Commission UNICOM Project: Up-scaling the Global Univocal Identification of Medicines”, which will focus on UNICOM Project activities to promote health system interoperability through the adoption and implementation of the ISO IDMP standards.
“Roadmap to Electronic Product Information: Moving from Principles to Actions”, a session that will focus on both the technical and (digital) health literacy aspects through a multi-disciplinary panel discussion, to create a vision on how the patient information leaflet should be used 5 years from now.
DIA Europe is the event for all life science professionals working in drug development, from discovery to marketed use taking place in Brussels 29-31 March 2022.
Visit the DIA Europe 2022 website for detailed information.
Do you need more insight on ePI? Read a recently published interview with Elizabeth Scanlan (EMA) and Erol Hofmans (MEB), on the development of a European common standard for electronic product information (ePI) published in MEB’s Regulatory Science, Edition 14. In the interview, they cover the key principles for ePI, and how ePI will bring both efficiency gains to regulatory processes and benefits for public health.
