In February 2020, the European Commission unveiled its data strategy, culminating in the creation of an infrastructure and governance for the free flow of personal data under the control of individuals. Following this announcement, Digital New Deal has published Personal Data Sharing: Governance as a Game Changer. Governance is needed to enable the switch from […]
As one of the highlights of Germany’s Presidency of the Council of the EU, the High-Level Conference “Digital Health 2020 – EU on the Move” aims at advancing discussions in the area of digital health. Federal Minister of Health of Germany, Jens Spahn, will open the conference bringing together representatives from all parties involved in […]
The UNICOM monthly, interactive Community of Expertise webinar sessions address issues related to the identification of medicinal products (IDMP) in regulatory and clinical contexts. On Thursday November, 12th UNICOM holds the fourth CoE webinar addressing: How substances/products have been selected for piloting, and How this is moving to support use of IDMP data across multiple domains […]
The UNICOM monthly, interactive Community of Expertise webinar sessions address issues related to the identification of medicinal products (IDMP) in regulatory and clinical contexts. On Friday, 4 December, UNICOM holds the fifth CoE webinar addressing how IDMP is supporting COVID-19 immunization: A number of new vaccines will arrive on the market with the purpose to […]
How digitalisation can support the regulatory business process Britt Vermeij, Vice-Chair of the Regulatory and Scientific Affairs Committee Medicines for Europe, TEVA - A coherent data strategy as foundation to respond to public health needs Remco Munnik, Chair of the Telematics WG Medicines for Europe, Iperion - Open dialogue between industry and regulators: How digitalisation […]
UNICOM – Pharmaceutical Dose Forms The presenters will share their perspective on how the pharmaceutical dose forms have been developed and are currently used in different situations. They will give insight in the current revision of the ISO standard, which intends to provide easier means to define world wide unique pharmaceutical dose forms.
The objectives of this Workshop are to present in some detail the history, and particularly the present organisational structure, data flows and technical details of the ePrecription/eDispensation and Patient Summary healthcare services as provided in the context of the CEF eHDSI and to give a preliminary glimpse of the new requirements resulting from IDMP implementation […]
The objectives of this Workshop are to present in some detail the history, and particularly the present organisational structure, data flows and technical details of the ePrecription/eDispensation and Patient Summary healthcare services as provided in the context of the CEF eHDSI and to give a preliminary glimpse of the new requirements resulting from IDMP implementation […]
The UNICOM project has compiled and published a set of requirements for a new IDMP logical model, which shall be technology independent. Currently, the IDMP data model is described by partial logical models across the different standards making up the IDMP set of standards and by HL7 v3 based specifications in some of the technical specifications. The ISO group of experts will take these requirements as input for the development of a new ISO IDMP logical model. Our discussion of the requirements will also be made available to the ISO experts, as they join the conversation.
Joint Initiative Council Open Forum - Morning Session Transcending national boundaries and organizations, the Joint Initiative Council’s standards development organizations work collaboratively to provide global, coordinated—not competitive—standards that address real-world healthcare issues. In its recently released white paper, the JIC explores the desired future of a digital health ecosystem where high-quality data is available to […]
Transcending national boundaries and organizations, the Joint Initiative Council’s standards development organizations work collaboratively to provide global, coordinated—not competitive—standards that address real-world healthcare issues. In its recently released white paper, the JIC explores the desired future of a digital health ecosystem where high-quality data is available to the right people, at the right place and […]
The current status of UNICOM work and expected results is presented by C.Hay (WP1) at the meeting of the International pharmaceutical regulators programme (http://www.iprp.global/home)
Preliminary Program Welcome – Agenda State of play with Vaccination Standards in Europe: an overview Christof Gessner, HL7 Europe Board of Directors, HL7 Germany What is the state of play of implementations across Europe? Role of HL7 Standards? Role of Affiliates? collaborations – decision-making practices – vendor engagement? Vaccination Standardization Efforts across Europe (deep dive, […]
UNICOM – EMA Implementation Guide v2.0 The course of IDMP implementation in Europe is strongly influenced by European Medicines Agency's (EMA) guidance. On Monday 22 February, EMA released version 2.0 of its Implementation guide (EU IG v2.0). This is a very important milestone for UNICOM and our communities, which will be presented and discussed at our […]
Understand the issues at stake and make your voice heard by attending the first UNICOM event targeted at national and European healthcare professionals and patients' organisations Download PDF Register NOW
The importance of medicinal product dictionaries (MPDs) is highlighted by two concrete examples. MPDs bring together the information on medicinal products from NCA and a variety of sources. Making sure that the identification of the medicinal product across these sources can be done automatically and without error, makes the implementation of IDMP such a crucial […]
UNICOM – Representation of clinical information related to medication using SNOMED CT and other standards This webinar will illustrate the use of SNOMED CT and other standards for the representation and use of clinical information in a select number of scenarios across the UNICOM landscape of IDMP implementation. The MHRA will demonstrate the use of SNOMED CT coded data in an actual electronic health […]
Initial roundtable discussion of groups involved in Adverse Events hosted by the FHIR Clinical Research Accelerator "Vulcan". Representatives from UNICOM T8.4 will "sit at the (round)table".
The meeting will update US key decision makers on the objectives and current achievements of UNCIOM and will open the way to to wider and more focused discussions on alignement possibilities. The EU UNICOM Trans-Atlantic Stakeholders Webinar will be officially coordinated by *CTADHL, a UNICOM partner formally tasked for trans-Atlantic outreach by UNICOM to include […]
Register here: https://connectathon.ihe-europe.net/connectathon/ihe-europe-experience
IDMP in Europe - what does it mean for you? Presentation by Robert Stegwee Free registration at: https://connectathon.ihe-europe.net/experience-sessions-tuesday-15-june
UNICOM – Cross-border ePrescription - standards, terminologies, processes You will learn what UNICOM is expected to contribute in order to make this service truly operational and reliable: The implementation of IDMP across Europe provides important opportunities for the improvement of cross-border services, such as ePrescription. UNICOM is tasked with elaborating these opportunities into change proposals […]
What is the relation between INN, ATC and substance identification according to IDMP? For the identification of substances, IDMP relies on data available in the Global Substance Registration System (GSRS). Its European counterpart EU-SRS is being implemented, supported by UNICOM WP 2, where an important data cleansing work is in progress. This webinar will cover the […]
The presentations will focus on the background, purpose, and governance of each of these identification and classification systems as well as their linkage. The discussion will also address how their use outside the originally defined scope may have consequences and limitations for the correct use of medicinal products across the countries. Presenters: Dr Rafaella Balocco […]
A medicine’s ePI ( Electronic Product Information) is regulated, scientifically validated information to assist healthcare professionals in prescribing and dispensing, and informs patients and consumers about their medicine and its safe use. Thus, trusted access and understanding of up-to-date product information on medicines when and where it is needed is extremely important. In Europe, the […]
Defining characteristics for dose forms, which meet global needs, is a challenge addressed by EDQM and several stakeholders. This webinar will present the views regarding the “global” aspect of dose form definition: in the regulatory space, in the clinical space, in the domain of adverse event monitoring and what efforts EDQM is deploying to meet […]
Dear members of the UNICOM Consortium. You are cordially invited to the HL7 Europe Listening Session. The purpose of this session is to inform the HL7 International community of specific developments in European countries and Europe as a region. Short topical introductions will be provided by the Board Chair of HL7 International and some of HL7 […]
This year the 19th International Conference on Informatics, Management, and Technology in Healthcare (ICIMTH 2021) is announced as an eConference (no physical presence is required) due to the COVID-19 pandemic. The Conference (www.icimth.com) will be held for this year on: 16-17 October, 2021. The modification of the traditional Conference to a Virtual event is due to […]
The world is teaming up to provide clarity on the identification of substances and the representation of strength. This Community of Expertise will present different recent perspectives on these activities, with speakers reprensenting the views and work of regulatory, industry and standards stakeholders. Speakers: Isabel Chicharo, EMA: Implementing substance cleansing results in SMS Petra Kristic, […]
Scenarium in cooperation with Fundisa - African Academy of Medicine Development, supported by GHA-German Health Alliance as well as other prominent partners are organising the first edition of an international workshop on Health Economics and Pharmacoeconomics: Opportunities for German-African Cooperation October 30-31, 2021 hybrid event The workshop will take place simultaniously at University of Potsdam, […]
This is a closed event. We already had presentation from a number of partners and this time we kindly invite: - BfARM (DE) - ARMPS (BE) - INFARMED (PT) to present lessons learnt from their view. We also invite ALL partners to share experiencies during the discussion.
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 […]
Date: 18/03/2022 Location: Online, 14:00 - 16:00 Amsterdam time (CEST) How to request access to SPOR API Where to find SPOR help and support SPOR API resources and concepts SPOR API demo SPOR API tips for better use/querying Registration
UNICOM will be present in the DIA event in the following sessions: Wednesday, March 30th, 13:15 - 14:15, Hall 100: link to the session Thursday, March 31st, 09:00 - 10:15, Hall 100: link to the session
Worshop upon invitation only. If you wish to attend, please send a request to The workshop objectives are the following ones: - Participants will be able to understand and read FHIR messages describing medicinal products; We will be using draft FHIR-messages provided by EMA/DADI - Seceral National Competent Authorities will also prepare examples which […]
During this third trans-Atlantic meeting we will have a focus on the adoption of the IDMP data model and related IDMP activities in the US. Additionally other global IDMP activities will be addressed. Welcome, introduction to CTADHL and UNICOM (Vada Perkins, Frits Stulp and Christian Hay) Main & Open discussion Introduction: US (Elaine Johanson, […]
IDMP implementation will be the central topic on April 6 but many other sessions will also have IDMP in the background. UNICOM will be represented in two sessions at 10.45 and 15.45 on April 6. All infos and agenda:
Semantic specifications for eHealth services This webinar will present a selection of requirements identified by UNICOM WP 5, detailed in its draft deliverable D5.4, "Semantic Specifications". Their purpose is to support semantic interoperability to be considered in local, national or regional specifications for electronic prescription, electronic dispensation and patient summaries. The requirements are a source […]
During the next HL7 VULCAN Accelerator, the focus will be on the FHIR specification set up by the European Medicines Agency on Electronic Product Information and more partcularly FHIR standard for Patient Information Leaflets of Medicines. More info: https://unicom-project.eu/join-the-unicom-and-gravitatehealth-for-the-next-epi-hl7-vulcan-accelerator-on-may-3-13-14-cest/
An UNICOM abstact has been accepted. UNICOM is thus proud that it will be part of the official programme with a full oral presentation. Lin to the event: https://mie2022.org/
Those webinars are meant to facilitate an early and detailed cross-fertlisation between European National Competent Authorities. Ireland (HPRA) will be presnting its current sttaus on its road toward IDMP implementation. All staff of all European agencies are warmly welcome to attend. If you have not received an invitation but would like to attend, please send […]
The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.
