Electronic Medicinal Product Information (ePI) FHIR Implementation Guide, published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Credits

Credits

This Implementation Guide was developed under the auspices of the HL7 Vulcan Accelerator’s Electronic Product Information project team and the Innovative Medicines Initiative’s (IMI) Gravitate-Health project. Contributing individuals and organisations are as follows (in no particular order):

Current ePI project Co-Chairs:

• Craig Anderson - Pfizer
• Catherine Chronaki - HL7 Europe

Project Team Members:

• Jens Kristian Villadsen - Trifork
• Giorgio Cangioli - HL7 Europe
• Amy Cramer - J&J
• Evinn Drusys - AEMPS
• Adam Kover - Felleskatalogen
• Bente Jansen - Felleskatalogen
• Arif Govani - DataPharm
• Philippe Michiels - DataPharm
• Michael Loewe - Rote Liste
• Carina Bachman - Rote Liste
• Josephine Bergman - Rote Liste
• Petter Hurlen - Akershus University Hospital
• Martin Ingvar - Karolinska Institute
• Adam Stiling - Roche
• Niklas Jänich - Boehringer Ingelheim
• Joseph Mundi - Pfizer
• Beverly Buckta - Pfizer

Vulcan Program Management

• Hugh Glover - Bluewave Informatics/HL7 BR&R/Vulcan
• Michael Van Campen - Vulcan
• Shani Sampson - Vulcan
• Bret Heale - Vulcan
• Jean Duteau - Vulcan

With contributions from other members who have from time to time, or quietly, participated in meetings, attended conference calls, and supported the core team during the development process.

If you are interested in participating in the Vulcan ePI project, further information can be found on HL7 Vulcan’s Confluence pages here.

Gravitate Health

The Gravitate Health project is a public – private partnership with 39 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), funded by the Innovative Medicines Initiative (IMI) – a joint undertaking of the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), IMI2 Associated Partners.

HL7 Vulcan Accelerator

HL7 FHIR® accelerators are a successful catalyst for standards development and adoption.

The vision for an Accelerator dedicated to connecting clinical research and healthcare was solidified in September 2019 by a group of invested representatives from government agencies, academia, technology companies, standards development organizations, patients, and industry consortiums. The Vulcan Accelerator serves the needs of the clinical and translational research communities through the implementation of HL7 FHIR standardized data exchange.

Vulcan’s goal is to create an ecosystem where research stakeholders collaborate on common use cases with the purpose of simplifying the research communities exchange of data using common standards with health records. Vulcan consists of organizations who represent the entire research stakeholder community including vendors, sponsors, CROs, consulting companies, sites, patient organizations, government agencies and growing.

HL7 Biomedical Research and Regulation (BR&R)

BR&R creates and promotes standards to facilitate biomedical research and any subsequent regulatory evaluation of the safety, efficacy and quality of medical products that may arise from research.

The BR&R workgroup areas of interest encompass clinical and translational research, both regulated and non-regulated, and the subsequent regulatory submissions and information exchanges to bring new products to market and to ensure safe use throughout the product lifecycle.

This Work Group facilitates the development of common standards and the maintenance and enhancement of the research-focused domain analysis model for clinical research information management across a variety of organizations, including national and international government agencies and regulatory bodies, private researchers and research organizations, sponsored research, CROs and other interested entities.