UNICOM partner will orchestrate a cross border use case in the interoperability showcase. GNOMON will also make one cross border presentation in the tech leaders stage in the exhibition hall.
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Unicom developments around IDMP from a NCA (AGES) perspective by George Neuwirther IDMP Ontology by Heiner Oberkampf and Raphael Sergent EU-SRS by Annet Rozema
A report on progress and challenges from the Global IDMP Working Group (GIDWG), about substances. The presentation will give an overview of the GIDWG work on global alignment of substances, the role of a global substance ID in the medicinal product lifecycle and the challenges faced. The presentation will also demonstrate how a new resource […]
In the context of the IHE-Europe Connectathon WEEK 2023 | Connectathon in Rennes France and in parrallel to the French eHealth week. Looking across the landscape of IDMP implementation, the UNICOM project aims to develop the following testing scenarios as part of the UNICOM Test Lab: • Submission of variations When a pharmaceutical company needs […]
REGISTER NOW FOR THIS EVENT Advanced FHIR training: How to track changes on a medicinal product? UNICOM is happy to invite all of you to the 4th NCA FHIR training on October 13 10-12 CEST. This webinar focus topic is: “How to track changes on a medicinal product?” "Provenance" in the Variation FHIR message: Free text […]
Agenda: Introduction to Fimea Medicinal product database demo Lessons learned Priority actions expected from EMA Speakers: Joonas Tuominen (Fimea) Anu Ollikainen (Fimea) Markus Mäkelä (Fimea) Juha Jokimäki (Solita Finland Oy)
Unicom will be presenting all the results of WP2 related to SUBSTANCES
Annet ROSEMA from CBG in the Netherlands, Christian HAYE from GS1 and Frit Stulp will represent UNICOM during this event where UNICOM will be the red string of most strategic sessions. Have a look at the agenda: https://informaconnect.com/global-pharmaceutical-regulatory-affairs/agenda/1/
Across the UNICOM project we have been actively developing a number of standards-based resources, including FHIR Implementation Guides, a Product Lifecycle Management portal (with EMA), an IDMP database, a substitution service for cross-border dispensation, and a few patient facing apps with dedicated API’s to access medicinal product information (with Gravitate Health). These resources are meant […]
For National Competent Authorities, IDMP implementation is not an option and is already legally compulsory for pharmacovigilance. Industry has already started to submit data in the IDMP format for CAP products variation forms and this will soon be extended to all other forms. NCAs need thus to : Adapt their IT systems (and all other […]
