UNICOM - general information
| Year | Title | Description | Download |
|---|---|---|---|
| 2020 | UNICOM Fact Sheet | Short introduction to UNICOM Action lines, objectives | PDF File |
| 2020 | BADI Bulgarian Drug Regulatory Affairs e-Congress (June 2020) | The slides present the objectives pursued by UNICOM to a EU regulatory authority and Bulgarian key stakeholders not directly active within the UNICOM consortium. | PDF File |
| 2020 | HL7 FHIR / Unicom Joint Meeting (May 2020) | Karl Stroetmann presents the objectives purused by UNICOM and its implementation challenges including the synergies to be found with SDOs such as HL7/FIHR. | PDF File |
| 2020 | Commentary published in the review Vaccine | Commentary published in the open source journal Vaccine on December 2 2020. It details the urgent actions needed to ensure we can track and trace the global use of COVID-19 vaccines. | PDF File |
IDMP and related standardisation(s)
| Year | Title | Description | Download |
|---|---|---|---|
| 2020 | Working Document: Gap Analysis of Existing and Need for New Standards and Profiles | Work package 1 focuses on IDMP-related standards and terminologies; its first deliverable is concerned with gaps in existing standards and profiles, and the arising need for adapted and new ones. | PDF File |
| 2020 | Medicinal Product, Marketing Authorization, Pharmaceutical Product and Package Medicinal Product: Briefing Note by Jean Gonzague Fontaine (GSK) | The slides provide an overview of the relations between • MPID• PhPID• MA• PCID (and then, DCID) and explain the possible hierarchy between these IDs. | PDF File |
| 2020 | IDMP related standards and terminologies applied to pharmacovigilance: Presentation Individual Case Safety Report. Briefing note by Anja van Haren | The slides briefly describe the expected benefits of IDMP implementation for the pharmacoviguilance domain. | PDF File |
| 2021 | Working Document: Requirements for a new ISO logical model [platform independent] | The document raises requirements for the development of a new IDMP logical model, to serve as a reference to implementers and developers of specific data models. It presents what is meant by a “logical model”, provides several references which document logical models and their conceptual, standardised framework. | PDF File |
| 2021 | The UNICOM Project Pilot Product List: Presentation to the HL7 BR&R Workgroup (26/01:2021) | The slides show how the products pilot list which will be tested by UNICOM are the pivotal element which will help make IDMP truly operational. | PDF File |
European Substance Registration System
| Year | Title | Description | Download |
|---|---|---|---|
| 2020 | Working Document: Endorsed Implementation Plan for Substance Management | This deliverable presents the Implementation Plan for Substance Management, i.e. the roadmap for the EU Substance Reference System (EU-SRS) implementation. | Soon available |
| 2020 | WP2-Cleaned Substances Report | The EU SRS excel file is a searchable database for stakeholders interested in using this information | xlsx File |
| 2020 | WP2-Data cleansing Manual | The Data Cleansing Manual Substance Validation Group (SVG) has developed this “Guidance on EU Substance Data Cleansing” as part of the EU-SRS project. This is an External version- living document. | PDF File |
