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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 (EN)	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 (FR)	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
2022	Working Paper on IDMP education and certification programs	This 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 modules	PDF File
2023	IDMP σε κάψουλα (GRà	Το IDMP σε μια κάψουλα, βοηθά στην προώθηση της καλύτερης κατανόησης σχετικά με το πώς «λειτουργούν» τα πρότυπα IDMP σε όλα τα στάδια του κύκλου ζωής ενός φαρμακευτικού προϊόντος. Από το αρχικό στάδιο Ανάπτυξης και Παραγωγής έως το τελικό στάδιο Αξιοποίησης και Αξιολόγησης Αποτελεσμάτων, οι έννοιες και η θεωρία των προτύπων IDMP εξηγούνται ως μέρος δύο ιστοριών: το SweetDreams, ένα φαρμακευτικό προϊόν και η Ίνγκριντ,.	PDF File
2023	IDMP en una pildora (SP)	Este documento es uno de los entregables de UNICOM. Ofrece una visión simplificada de cómo IDMP podría mejorar la seguridad en el ámbito de los medicamentos.Esta visión no implica la aprobación de UNICOM ni de ninguna de sus partes interesadas. Se ha redactado con carácter informativo y, por tanto, no tiene carácter normativo.IDMP en una cápsula, ayuda a promover una mayor comprensión sobre cómo podrían “funcionar” las normas IDMP a lo largo de las etapas del ciclo de vida de un medicamento.	PDF File
2023	IDMP in una capsule (IT)	Questo documento fornisce una visione semplificata su come gli standard ISO IDMP potrebbero supportare processi più sicuri nel settore dei farmaci. Questa visione non implica l’approvazione di UNICOM o di uno dei suoi stakeholder. È statascritta a scopo informativo e non ha quindi carattere normativo. “IDMP in a capsule” aiuta a promuovere una maggiore comprensione di come gli standard IDMP potrebbero “funzionare” durante le fasi del ciclo di vita di un medicinale. In ogni fase – da quella iniziale dello sviluppo e della produzione a quella finale Introduzione al documento	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	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
2022	Working 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 uses	This 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 resolution	PDF File
2022	FHIR TRAINING (EMA DADI FHIR variation forms)	The slides introduce the Variation FHIR Message Conceptual Model, Mapping of Fields DADI UI to FHIR Message and explain how to extract information out of a FHIR message	PDF File
2022	Working Document: Implementation Guidance for Identification of Medicinal Products (IDMP) in Medicinal Product Dictionaries	This 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.	PDF File
2022	Demonstrator: scenario-testing for HL7 FHIR conecthatons	This set of slides describes the senario testing of Helen who is a 38 year old business lawyer. She lives in the UK and travels often to other European countries for work. She has Diabetes type 1 which she controls with medication (Humalog Mix50 daily). One PDF includes the notes while the other one also shows the notes.	PDF File PDF File
2023	IDMP & FHIR for NCAs	The slides were explained during a specific webinar targeted at all European NCAs organised on March 10. It aims at bringing both business and IT people of recent strategic development related to IDMP implementation and iuse of the FHIR Standards	PDF File
2023	FHIR training for NCAs: How to track changes on a medicinal product?”	The slides were explained during a specific webinar targeted at all European NCAs organised on October 13 2023. It builds on the information provided in the previous 3 FHIR webinars with a focus on How to track changes on a medicinal product?” “Provenance” in the Variation FHIR message:	PDF File
2023	IDMP & ATC	Presentation of Prof Dr Robert VANDER STICHELE on IDMP for the the WHO Collaborating Centre for Drug Statistics Methodology on October 3 2023.	PDF File
2024	Summary of clinical workshop in Brussels	Three illustrative use cases were explored in-depth during this meeting: e-prescription, adverse events reporting and drugs shortag	PDF File
2024	Working Paper: Application of IDMP in Drug Labelling and Drug Information, in Clinical Decision Support and in Quality Assurance of Clinical Data	Tjhis document explores what IDMP can mean for quality of care in pharmacotherapy, and how it can be integrated in clinical decision support systems	PDF File
2024	Working Paper: IDMP-ICSR Clinical Connectivity	This document explores the use of ADR reporting features in clinical system software, with emphasis on identifying reusable initiatives and characterising their use of medication description for suspect and concomitant medication	PDF File
2024	Working Paper: Results of UNICOM Personalised Medicine Pilot	This document reports the results of the “Personalized Medicine Pilot” that was performed at FOUND	PDF File

IDMP-adapted submission forms and national implementations

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Cross-border aspects

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Presentations | Documents

Year	Title	Description	Download
2020	Polypharmacy 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 2020	PDF File
2020	White 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.	PDF File
2020	Presentation of UNICOM at SNOMED virtual expo-October 2020 – by Robert Stegmee and Jane Millar	The 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
2020	Initial Gap Analysis on Standards Development -Presentation at HL7 International Work Group Biomedical Research & Regulation (BR&R) September 2020	Those 4 slides briefly summarize the identified gaps in WP1 for the HL7 WG audience	PDF File
2020	Keynote lecture by Prof. K. A. Stroetmann “Global patient safety through semantic interoperability – the univocal identification of medicinal products	Presentation 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 Policy	PDF File
2020	Commentary written by some UNICOM participants published in the review Vaccine	Commentary 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
2020	Pharmaceutical 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
2021	EHTEL factsheet: Towards a European Data Space for Medicines	This 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.	PDF File
2021	Ensuring 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
2021	UNICOM curent status – Presentation for the International Pharmaceutical Regulators Programme (IPRP) on the 24th of February	This 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
2021	Use of EDQM to produce PhPID – Presentation at WG6 Pharmacy ISO/CEN on June 2 2021	Results 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)	PDF File
2021	IDMP 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
2021	Update 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 community	PDF File
2021	Second transatlantic meeting: First UNICOM results	On 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
2022	Presentation of UNICOM to the Gravitate Health Consortium	UNICOM has a priviledged relationship with the IMI project Gravitate Health which involves among others a large number of Pharma companies.	PDF File
2022	Scientific article published in APPLIED SCIENCE: How Granular Can a Dose Form Be Described? ConsideringEDQM Standard Terms for a Global Terminology	The 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 terminologies	PDF File
2022	Medicinal Product Data Standardisation – Prerequisite for Efficient Data Exchange Between Stakeholders and Impact on the (Inter)National Health Systems: Experience from Croatia	The National Medicinal ¨Products Agency of Croatia explains in details its migration journey to IDMP	PDF File
2022	EMA 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
2022	Scientific 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
2022	UNICOM 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 enviironment	PDF File
2022	Relevance 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
2022	HPRA presentation on June 26 FAMHP presentation on March 29th on its IDMP implementation journey	The slides provide insightS into the strategy chosen by IRELAND to refactor its IT sytem to make it IDMP compliant	PDF File
2022	UNICOM Presentation at EDQM September 27, 2022, Standard Terms Working Party, EDQM, Strasbourg	Those slides provide a complete analysis of EDQM as a global terminology for dose forms ,propose a few improvements and introduce a proposal for an ontology of dose form	PDF File
2022	MPA (Sweden) update of its IDMP implementation approach	The slides focus on Strategy, project management and development of IT-systems, alignment and use of RMS, alignment and use of OMS and MPA stepwise approach adaptation of IDMP	PDF File
2022	UNICOM presentation for EFPIA PVEG WG	Those slides explain the relevance of the implementation of the IDMP standard for pharmacovigilance and were created to inform the EFPIA WG on phramacovigilance	PDF File
2023	UNICOM presentation in Paris for the HL7 Vulcan Accelerator days.	Those slides focus more specifically on describing how IDMP and FHIR are the main ingerdients of the UNCOM wedding cake.	PDF File
2023	HALMED presentation on March 29th on its IDMP implementation journey	The slides provide a clear insight into the strategy chosen by HALMED to refactor its IT sytem to make it IDMP compliant	PDF File
2023	FAMHP presentation on March 29th on its IDMP implementation journey	The slides provide an overview of the IDMP GAP analysis perfomed in Belgium and explains how MPs data are integrated in a unique source used by end-users.	PDF File
2023	NoMA presentation on MaY 26th on update of SAFEST project, solutions for dose forms and PhPID generation	The slides provide an update of the SAFEST project which makes availlable IDMP MPs data to clinical practice, focus on solutions for dose forms representation in clinical practice and adresses the PhPHID generation in collaboration with WHO-UMC	PDF File
2023	UNICOM day during the IHE Connectathon in Rennes in september 2023	The slides provide a comprehensive overview of the 5 UNICOM use cases selected: their current status- the connexion with other profiles – and the prospects.	PDF File
2023	Presentation on user-facing apps during UNICOM day IHE Connectathon in Rennes in September 2023	The slides provide an overview of the user-facing apps	PDF File
2023	FIMEA presentation pn October 20 on its IDMP implementation journey.	The slides provide an updated presentation on tne progress made to date by FIMEA to adapt its DB to make it IDMP compliant	PDF File
2023	BfArM (Germany) presnetation on December 6 on its IDMP implementatioin journey	The slides provide an updated presentation on tne progress made to date by BfArM to adapt its DB to make it IDMP compliant	PDF File
2024	I-HD presented on April 18 for a conglomerate of universities, tech and business schools, eager to build innovative implementations.	The slides focus on IDMP implementation implications for electronic health records, prescribing, medical education, rational drug therapy	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.

Year	Title	Description	Download
2016	D1.3 Initial openMedicine infostructure	This 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
2016	D2.3 Final identifying and descriptive attributes	This 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
2016	D3.2 Identification and description of special products	This 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
2016	D4.1 Other descriptive needs, product administration and alternative treatments	This 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
2016	D5.2 Meeting the substitution challenge: Member State regulations and core cross-border issues – results and recommendations	This 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
2016	D6.3 Recommendations and Implementation Roadmap	This 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