This is a closed event. We already had presentation from a number of partners and this time we kindly invite: - BfARM (DE) - ARMPS (BE) - INFARMED (PT) to present lessons learnt from their view. We also invite ALL partners to share experiencies during the discussion.
The Digital Application Dataset Integration (DADI) project will replace PDF electronic application forms (eAF) used for regulatory submissions with online forms, making the future form-filling and submission-handling process more efficient. This first public webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about the following: DADI roadmap […]
This second public webinar is for technical experts from industry and national competent authorities wishing to learn more about the design of the FHIR message for the first form to be updated: Human Variations. Despite the focus on human medicines, all stakeholders interested in the technical aspects of the FHIR message are welcome. Topics addressed in this webinar […]
This webinar is an introduction to the Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users. The morning session, from 10:00 to 11:30, is dedicated to RMS: Introduction to RMS RMS processes: Data Stewardship (CRs, deltas ) and Service Desk RMS Statistics: CRs & SLAs, Service Desk & SLAs, Customer satisfaction […]
Date: 18/03/2022 Location: Online, 14:00 - 16:00 Amsterdam time (CEST) How to request access to SPOR API Where to find SPOR help and support SPOR API resources and concepts SPOR API demo SPOR API tips for better use/querying Registration
Semantic specifications for eHealth services This webinar will present a selection of requirements identified by UNICOM WP 5, detailed in its draft deliverable D5.4, "Semantic Specifications". Their purpose is to support semantic interoperability to be considered in local, national or regional specifications for electronic prescription, electronic dispensation and patient summaries. The requirements are a source […]
Those webinars are meant to facilitate an early and detailed cross-fertlisation between European National Competent Authorities. Ireland (HPRA) will be presnting its current sttaus on its road toward IDMP implementation. All staff of all European agencies are warmly welcome to attend. If you have not received an invitation but would like to attend, please send […]
The next UNICOM Community of Expertise is scheduled on Friday 26 August 2022: In collaboration with the Gravitate Health project and the Vulcan Accelerator ePI project, UNICOM has contributed to a track at the May HL7 FHIR Connectathon. The scenario being developed was on a travelling lady needing treatment to a recurring condition, for which […]
The 4th of November a Community of Expertise will be held for which you have been invited. The presenters will be Annet Rozema, Mirjam Keulen & Marcel Hoefnagel from CBG, The Netherlands, UNICOM WP 2. Substances have been the topic of the UNICOM Community of Expertise before and this is not a surprise as substances […]
Take part today at 13.00 in the 5TH ePI Vulcan accelerator discussion with a joint input of both UNICOM - Up-scaling the global univocal identification of medicines and Gravitate Health -> All the detailed information about the track can be found here: https://lnkd.in/eD8x3TQu This is the 5th event in the series of companion events to Vulcan ePI Project […]
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 […]
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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 […]
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 […]
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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
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, […]
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 […]
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 […]
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 […]
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.
