Community of Expertise: Substance identification using INN and ATC – governance, use, and relation to IDMP

The presentations will focus on the background, purpose, and governance of each of these identification and classification systems as well as their linkage. The discussion will also address how their use outside the originally defined scope may have consequences and limitations for the correct use of medicinal products across the countries. Presenters: Dr Rafaella Balocco […]

Annual workshop about lessons learnt (UNICOM NCAs)

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.

Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms

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 […]

Digital application dataset integration (DADI) webinar – common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF)

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 […]

EMA SPOR webinar: Introduction to the Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users.

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 […]

Community of expertise: Semantic specifications for eHealth services

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 […]

National Competent Centers knowledge exchange webinar: Focus on Ireland

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 […]

Community of Expertise: Navigating global and national identifiers using IDMP and FHIR

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 […]

UNICOM Community of Expertise: SUBSTANCE and EU-SRS

Webinar via Zoom

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 […]

5th HL7 FHIR ePI Vulcan accelerator

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 […]