Description: The landscape of use of medication data is quite broad and diverse. When looking at standards for the exchange of medication data, including the terminology mappings needed to cross the borders between the different domains, it is important to identify the original sources of the data being exchanged. These sources are the key first […]
This event is a webinar for industry and national competent authorities’ stakeholders wishing to learn more about data migration activities from SIAMED and xEVMPD databases to PMS
UNICOM is happy to announce a new series of IDMP implementation related training and knowledge transfer webinars in 2023. Considering the recent progress with EMA eAF we believe that it is important that all European NCAs acquire without delay a better understanding of the FHIR standard and its relevance in relationship to a wide IDMP […]
HL7 FHIR® is the communication standard for exchanging healthcare data being adopted worldwide. Past announcements from the FDA and current developments by the European Union (EHDS, EMA) and important and strategic projects such as UNICOM and Gravitate Health all prioritize the IDMP suite of standards as global reference and FHIR as underlying data transmission standard. […]
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Agenda : 25’ Results of the FAMHP IDMP gap analysis: 1. EMA : deviations (more, less, different) versus ISO IDMP documents (of 2012 and 2017, whichever is more recent) 2. FAMHP MPM/DTS : differences with the EMA data model 3. FAMHP approach to narrow the gaps 10’ QUESTIONS 15’ SAM / ePrescription : dataflow from BE […]
►You can register for the relevant Webinar by selecting the link below: SPOR and XEVMPD Data Governance - 17 April, 10:00-12:00 CET - https://ema-europa.webex.com/weblink/register/r9ca0c1044ed05282d0fe236251c99a9c Service Desk for SPOR and XEVMPD - 17 April, 14:00-16:00 CET - https://ema-europa.webex.com/weblink/register/r1552802c0646096c101b5e62b25dfa5d Referentials Management Service (RMS) - 18 April, 10:00-12:00 CET - https://ema-europa.webex.com/weblink/register/r46516995ff51d5f4383d95f05cac8e38 Organisation Management Service (OMS) - 18 April, 14:00-16:00 - https://ema-europa.webex.com/weblink/register/r834ea26426a57529292e0dcffc96cb5a Substance Management […]
Description: Referring to the landscape of medicinal product data – from “research and development” to “utilisation and outcome assessments”- the vision is that the essential IDMP identifiers remain used and unchanged along that life cycle. This Community of Expertise (CoE) will provide opportunity : for industry to present their perspective and needs, with large international […]
Georg NEUWIRTHER will present UNICOM on May 5th at 10.00 AM. GERMAN SOCIETY FOR REGULATORY AFFAIRS (DGRA) The German Society for Regulatory Affairs e.V. is a scientific specialist society in the field of drug approval. It sees itself as a communication platform for employees in the approval departments of the pharmaceutical industry, authorities and scientific […]
Central thema: Administrable products : Based on relationship between manufactured and administrable dose form, - NoMA's solution to meet needs in clinical practice. REGISTER
Public webinar intended for business, developers and technical audiences working for industry and national competent authorities that are interested in learning more about the Product Management Service (PMS) development progress and related activities. PMS aims to deliver comprehensive and consolidated human medicinal product data (Centrally Authorised Products (CAPs) and Non-CAPs) from different sources. The webinar will be an occasion […]
This webinar is targeted at all European NCAs, eHealth competence centers and Industry (EMR, MPDs, HCP and Patient facing Apps). It will present and discuss the approach porposed by IHE to test and validate IDMP data (using UNICOM resources). The result of this webinar will feed the content of the IHE hacktathon which will take […]
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 […]
UNICOM Day - ensure that any medicine and what it contains can be accurately identified anywhere in the world. Improve patient safety and enable better healthcare for all Agenda: 9:30 AM - 9:35 AM: Welcome and Introduction (Alexander Berler - GNOMON) SESSION 1 9:35 - 10:00 AM: The promise of IDMP interoperability: the challenge of […]
The webinar is opened to all the staff of all Medicinal Products Agencies. If you want to be invited, send a mail to 1 Welcome: Georg, Sonja Noel 2: PHAROS - Implementation of ISO-IDMP Concepts: Georg, Sonja 3: PHAROS - Importing eAF data based on the new FHIR format (Variation of CPs): Sonja, Noel, […]
This year’s ePI Summit was hosted by ROTE LISTE®. In an era where innovation is transforming every industry, the pharmaceutical sector is no exception. This year’s summit has explored the latest developments, opportunities, and challenges in electronic product information. UNICOM explained why it - together with EMA- can provide a solid foundation to the topic. See: […]
The UNICOM project has been working to improve patient safety and enable better healthcare for all, through the implementation of IDMP related standards and terminologies within a variety of processes and systems across the landscape of medicinal product development, use and evaluation. Our key focus has been on the provision of safe medication data, using […]
Breakthrough 2024 is the must-attend event for life sciences leaders across the globe. It’s the one place where leaders like you engage in the brightest, forward-looking life sciences industry conversations and hear the latest LifeSphere announcements. Bringing together industry experts, pharmaceutical leaders, and regulatory authorities, Breakthrough 2024 will explore the transformation of intelligent automation - […]
UNICOM is hosting a workshop that aims to engage stakeholders in discussions about the advantages, challenges, obstacles, and timelines related to the implementation and utilization of IDMP in the clinical realm. This exclusive, one-day event, accessible by invitation only, is designed to showcase the advancements achieved within the UNICOM project and underscore the ongoing efforts […]
UNICOM presentation by Robert VDS for a conglomerate of universities, tech and business schools, eager to build innovative implementations. Link to presentation: https://unicom-project.eu/wp-content/uploads/2024/04/unicomGroningenApril2024.pdf
This event is not only about presenting the major results achieved by UNICOM over the last four years. It will first of all aim at anchoring those results in a long term perspective and make sure IDMP is part of any major implementation project related to the identification of medicinal products. SEE THE AGENDA: https://unicom-project.eu/wp-content/uploads/2024/02/UNICOM_FinalConference_Agenda_Invitation.pdf […]
Venue: Onsite: COCIR Office, Brussels Online, link will be sent after Registration Description: Multiple interoperability-focused technical artefacts have been developed during the UNICOM project. These artefacts describe how conformant digital health solutions will participate in standards adherent data exchanges. Several European Ecosystems as EHTEL or COCIR members that provide solutions that target European and/or International […]
UNICOM will be represented by NOMA, the Norwegian Medicinal Products Agency, during the Radical Health Festivalin Helsinki in a session dedicated to Interoperability - Beyond Techonology, Towards People and Systems Talking to Each Other If data is the lifeblood of an information-driven health system, interoperability is the cornerstone for implementing prevention and precision at scale. […]
The SNOMED CT in Europe conference will be held from May 22-23, 2024 at the Pullman Brussels Centre Midi hotel in Belgium. This inaugural event will feature speakers and stakeholders from across Europe. If you are involved in clinical terminology policy and implementation in Europe then this is the event for you. In addition to hearing presentations from influential […]
The webinar will be organised by UNICOM partner HARVARD MEDICAL SCHOOL and has as key objective to update the American interested audience about UNICOM results and discuss in particular some elements of divergence of major importance between the EU and the US . 🗓️ Wed, 05/22/2024 - 12:00 - 13:30 EST (18:00-19:30 CEST) Register Now! […]
The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.
