The UNICOM Trans-Atlantic meeting will be officially coordinated by *CTADHL, a UNICOM partner formally tasked for trans-Atlantic outreach by UNICOM to include promotion and adoption of ISO IDMP across the medicinal product lifecycle. Although UNICOM is an EU initiative, it strongly considers collaboration and exchange with North American stakeholders as part of its remit to […]
Topic: Using IDMP in Adverse Event reporting and Individual Case Safety Reports (ICSR) Date: 3 December between 3 – 4:30 pm CET Presenters: Anja van Haren Barry Hammond (UNICOM WP 1 and MedDRA) Sarah Vaughn (MHRA) Panelists: Julie James (UNICOM WP 9 and BlueWaves) Jane Millar ( UNICOM WP 1 and SNOMED CT)
This event is open to ALL National Competent Authoritities; If you have not received an invitation, send a request to the follwoing email adress: WP4 kindly invites you to the follow-up training based on the concept presentation we had last year. We will prepare a FHIR example. We will use EMA's LOSEC example as […]
The need for global identification of vaccines has been recognized in the Global Vaccines Initiative, addressing the global surveillance of vaccine effectiveness and risks. This has particular consequences for the European Substance Registration System, the focus of UNICOM WP 2, which will need to make sure that cleansing and building of substances is done in […]
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 […]
All infos here
Workshop only upon invitation. If you have not received an invitation altjough you work with or for an NCA and would like to take par: send a mail to
All info available here: https://unicom-project.eu/discover-what-can-idmp-do-to-improve-the-quality-of-drugs-dictionaries-and-support-best-etl-practices-during-our-community-of-expertise-on-february-25-at-15-00-cet/
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 […]
