Resources Demo Page

UNICOM – general information

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2020UNICOM Fact SheetShort introduction to UNICOM Action lines, objectivesPDF File
2020BADI 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
2020HL7 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
2020Commentary published in the review VaccineCommentary 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.
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2021UNICOM 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
2021IDMP 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.
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2021IDMP dans une capsuleIDMP 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
2022Working Paper on IDMP education and certification programsThis paper identifies five levels of required knowledge and describes applicable roles, possible means of education, instruction and certification. It also lists a number of prerequisites and recommendations which should be taken into consideration whilst developing the content and implementing educational modulesPDF File

IDMP and related standardisation(s)

YearTitleDescriptionDownload
2020Working Document: Gap Analysis of Existing and Need for New Standards and ProfilesWork 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
2020Medicinal 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.
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2020IDMP 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
2021Working Document: Requirements for a new ISO logical model
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
2021The 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
2021Working Paper:IDMP Coding Principles and Guidance for ICSRsThe 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 analysisPDF File
2021Digital Application Dataset Integration (DADI) Project Question and Answers Version 2This document is for information only and is based on insights available at the time of its release. It will be updated regularly.PDF File
2022Working Document: an analysis of the IDMP medicinal product identification data provided by NCAs (and SPOR) compared to that needed in MPD for clinical care and for secondary usesThis working paper describes MPD requirements, using the standards for MPD and how MPD are currently modeled and populated with high quality data to meet their business needs. It then describes what will likely be provided by the NCAs through IDMP, and then examines the gaps, uncertainties, challenges and possible mismatches between the requirements and the likely provision. Finally, it offers some insights into the issues and some recommendations for resolutionPDF File
2022Working Document: Implementation Guidance for Identification of Medicinal Products (IDMP) in Medicinal Product DictionariesThis document provides implementation and mapping guidelines for use of Identification of Medicinal Product (IDMP) data within Medicinal Product Dictionaries (MPD). It includes different scenarios of implementation depending on the structure of the MPD. It gives an overview on the controlled vocabularies/terminology from Substances, Products, Organisations and Referentials (SPOR) from the European Medicines Agency (EMA).
It will help MPD providers to use IDMP data for prescribing and for dispensing, nationally and for cross-border care.
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IDMP-adapted submission forms and national implementations

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Cross-border aspects

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Presentations | Documents

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2020Polypharmacy from a clinical perspective UNICOM partner Prof. Dr. R. Vander Stichele, Clinical pharmacologist at Ghent University, Belgium/ Senior Research Coordinator at I~HD, explains Polypharmacy concepts from a clinical perspective in the Horizon 2020 project C3-Cloud Webinar on 28 August 2020PDF File
2020White Paper written by nine SDOs, including CDISC, CEN, DICOM, GS1, HL7, IHE, ISO, LOINC and SNOMED International forming the Joint Initiative Council.Highlights from the JIC white paper include four standards-based initiatives that offer practical solutions to real-world problems. These initiatives include the International Patient Summary (IPS), the Identification of Medicinal Products (IDMP), COVID-19 and Genomics. The Joint Initiative Council’s SDOs work collaboratively to provide global, coordinated—not competitive—standards that address real-world healthcare issues.
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2020Presentation of UNICOM at SNOMED virtual expo-October 2020 – by Robert Stegmee and Jane MillarThe presentation describes the global problems tackled by UNICOM focusing more specifically on the relationship between IDMP and related terminologies. It explores also the role of SNOMED CT in this and informs about the ressources available to engage with the project.PDF File
2020Initial Gap Analysis on Standards Development -Presentation at HL7 International Work Group Biomedical Research & Regulation (BR&R) September 2020Those 4 slides briefly summarize the identified gaps in WP1 for the HL7 WG audiencePDF File
2020Keynote lecture by Prof. K. A. Stroetmann “Global patient safety through semantic interoperability – the univocal identification of medicinal productsPresentation made at a virtual evnet organized by the Tallinn Health Care College (THCC), Estonia in October 2020 on the theme: “Public Health & Healthcare in the Move — Opportunities and Challenges in Research, Practice and PolicyPDF File
2020Commentary written by some UNICOM participants published in the review VaccineCommentary published in the open source journal Vaccine on December 5 2020. The authors detail the actions needed to ensure we can track and trace the global use of COVID-19 vaccines.
PDF File
2020Pharmaceutical Strategy for Europe (Communication from the EU Commission)the Commission proposes a new pharmaceutical strategy for Europe. It is a patient-centred strategy that aims to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness. PDF File
2021EHTEL factsheet: Towards a European Data Space for MedicinesThis factsheet explains why the concept of European Health Data Spaces is particularly relevant for medicinal products with a focus on pharmacovigilance. It also analyses what has already been done by Member States in this field, with Belgium as an example, and considers the necessary next steps.
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2021Ensuring COVID-19 Vaccine Traceability – Article published in the volume 21 of the review healthmanagement.org by several UNICOM WP leaders.After the article published in Vaccine highlighted the need for global monitoring of vaccine use, HealthManagement.org has asked the authors about the challenges of implementing such system in practice and possible measures to minimise the accompanying risks.PDF File
2021UNICOM curent status – Presentation for the International Pharmaceutical Regulators Programme (IPRP) on the 24th of FebruaryThis slides set presnet to a wide community of regulators on all continents the objectives, opportunities of exchange and expected results o UNICOM. It inists in particular on the standards gap analysis, the logical model and the Products Pilot List.PDF File
2021Use of EDQM to produce PhPID – Presentation at WG6 Pharmacy ISO/CEN on June 2 2021Results of an analysis of the terminology of dose forms of
the European Directorate for Quality in Medicines (EDQM) Standardized Terms for Dose Form to determine the (administrable) dose form for the production of the Pharmaceutical Product Identification (PHPID)
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2021IDMP in Europe What does it mean for you?I Presentation at the IHE Europe Experience Sessions on June 15.WP1 provides a global overview of the high level processes at stake while focusing on the most prominent 5 clincial impacts.PDF File
2021Update on UNICOM progresses: 2nd eHMSEG Communities Meeting
on May 27
The presentation provides an update (as of May 2021) on the work and results achioeved by the UNICOM WPs for the eHMSEG communityPDF File
2021Second transatlantic meeting: First UNICOM resultsOn the 16th of November 2021, the CITADHL board organized the second trans-Atlantic workshop to introduce selected UNICOM work packages to US stakeholders. PDF File
2022Presentation of UNICOM to the Gravitate Health ConsortiumUNICOM has a priviledged relationship with the IMI project Gravitate Health which involves among others a large number of Pharma companies.PDF File
2022Scientific article published in APPLIED SCIENCE: How Granular Can a Dose Form Be Described? ConsideringEDQM Standard Terms for a Global TerminologyThe aim of the article is (1) to analyse the features of the EDQM terminology, (2) to formulate proposals for minor changes and (3) to create a small ontology of dose forms, based on characteristics of EDQM, and suitable for alignment with other dose form terminologiesPDF File
2022Medicinal Product Data Standardisation – Prerequisite for Efficient Data Exchange Between Stakeholders and Impact on the (Inter)National Health Systems: Experience from CroatiaThe National Medicinal ¨Products Agency of Croatia explains in details its migration journey to IDMPPDF File
2022EMA eAF Portal (DADI) guide to registration.The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).PDF File
2022Scientific article published in International Journal of Medical Informatics
Volume 165, September 2022, 104826
Analyis of alignment of two standard terminologies for dosage form: RxNorm from the National Library of Medicine for the United States and EDQM from the European Directorate for the Quality in Medicines and Healthcare for Europe PDF File
2022UNICOM presentation during the IHE connecthaton in Montreux (14 Sept 2022)Those slides present the current status of the project and the link with IHE testing enviironmentPDF File
2022Relevance of EU-SRS to global IDMP implementation and the UNICOM clinical Pilots (F2F meeting of the expert Group of the EU-SRS (Sept))Those slides explain how an automated extraction of variables that are crucial for legacy conversion in the agencies ca be performed ( and avoid time-consuming pharmaco-archeology activities). PDF File

OpenMedicine

OpenMedicine was a Horizon 2020 funded PHC, Grant agreement No.643796. UNICOM builds on the gaps recognized in OpenMedicine. Some relevant deliverables are listed below for reference as background material.
YearTitleDescriptionDownload
2016D1.3 Initial openMedicine infostructureThis deliverable’s goal is to present a multi standards framework that underpins solutions to identified issues in epSOS: the EU crossborder health data exchange specifications and its pilot results. In particular the identification of medicinal products and the attention to factors related to multiple contexts are addressed creating an infostructure, based on a multi standards framework.PDF File
2016D2.3 Final identifying and descriptive attributesThis deliverable’s goal is to present the final list of identifying and descriptive attributes of medicinal products. It also gives implementation recommendations based on the materials developed in other openMedicine deliverables. D2.3 has provided relevant input to D3.2, which will extend the attribute lists to special products.PDF File
2016D3.2 Identification and description of special productsThis report extends the solution towards supporting the identification and the description of such “special” products. Furthermore, it also presents the definition of alternative and complementary use cases where the unambiguous identification of such medicinal or/and pharmaceutical products is needed.PDF File
2016D4.1 Other descriptive needs, product administration and alternative treatmentsThis document presents clusters as a tool for grouping products with the same preselected attributes. It explores the concepts behind cluster formation and useful attributes which can help in a cross-border setting for such purpose.PDF File
2016D5.2 Meeting the substitution challenge: Member State regulations and core cross-border issues – results and recommendationsThis report reviews the initial openMedicine definitions of substitution and selection of a medicinal product at the point of dispensation in a community/retail pharmacy. the revised analytical framework concerning substitution and selection issues.PDF File
2016D6.3 Recommendations and Implementation RoadmapThis document presents some of the conclusions of the openMedicine project. Two high level and ten action-oriented recommendations are formulated. All of them, except one, address issues related to the univocal identification of a medicine when dispensing in a cross-border context an electronic prescription or when displaying a Patient Summary abroad. One recommendation addresses the issue of “substitution” in the EU.PDF File