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 |
| 2021 | UNICOM Citizen Survey Results (Feb-March 2021) | Summary of results from a survey of public opinion performed on what is important regarding patient care and empowerment when travelling outside one's home country, specifically related to medicine The associated task is ‘Define Patient Use Cases in Cross Border Settings’ | PDF File |
| 2021 | IDMP in a capsule | IDMP in a capsule helps promote greater understanding about how IDMP standards “work” throughout the life-cycle stages of a medicinal product. In each stage - from the initial stage of Development and Production through the final stage of Utilisation and Outcome Assessment - IDMP standards’ concepts and theory are explained as part of two stories: SweetDreams, a medicinal product, and Ingrid, its user. | PDF File |
| 2021 | IDMP dans une capsule | IDMP dans une capsule permet de mieux comprendre comment les normes IDMP “fonctionnent” tout au long des étapes du cycle de vie d’un médicament. À chaque étape - de l’étape initiale du développement et de la mise sur le marché du médicament à l’étape finale de l’utilisation et l’évaluation des impacts - les concepts et la théorie des normes IDMP sont expliqués dans le cadre de deux histoires : SweetDreams, un médicament, et Ingrid, son utilisatrice. | 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 |
| 2021 | Working Paper:IDMP Coding Principles and Guidance for ICSRs | The working paper provides recommendations for practical IDMP implementation aspects (e.g.,PhPID generation) and for handling drug information in general (e.g.,grouping concepts, use of name parts), aimed at improvingICSR data management and pharmacovigilance analysis | PDF File |
| 2021 | Digital Application Dataset Integration (DADI) Project Question and Answers Version 2 | This document is for information only and is based on insights available at the time of its release. It will be updated regularly. | 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 |
| 2021 | WP2-Data cleansing Manual v1.1 | 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 - UPDATED version 1.1 | PDF File |
