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Community of expertise: Cross-border ePrescription – standards, terminologies, processes

Webinar via Zoom

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 […]

Community of Expertise webinar: Substance identification using INN and ATC – governance, use, and relation to IDMP

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 […]

Community of Expertise: Substance identification using INN and ATC – governance, use, and relation to IDMP

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 […]

28th HL7 FHIR Connectathon -virtual 13-15 September 2021

Virtual

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 […]

Community of expertise: The role of Dose Forms in the generation of a global Pharmaceutical Product Identifier (PhPID)

Online Event - URL on Registration

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 […]

HL7 Europe: Listening Session

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 […]

19th International Conference on Informatics, Management, and Technology in Healthcare (ICIMTH 2021)

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 […]

Last perspectives on substance and strength in IDMP: Join us on the 29th of October!

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, […]

International Workshop Health Economics and Pharmacoeconomics (Postdam)

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, […]

Annual workshop about lessons learnt (UNICOM NCAs)

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.

Second UNICOM Trans-Atlantic Workshop

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 […]

Training workshop on FHIR for NCAs

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 […]

UNICOM Community of Expertise: Vaccine challenges – cleansing, confidentiality, and vaccine naming

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 […]

Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms

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 […]

Digital application dataset integration (DADI) webinar – common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Article 57(2) and electronic application forms (eAF)

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 […]

National Competence Centers IDMP Knowledge Transfer Workshop: Portugal in focus

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

EMA SPOR webinar: Introduction to the Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users.

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 […]

DIA EUROPE 2022 29-31 MARCH 2022 BRUSSELS & VIRTUAL

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  

National Competence Authorities: knowledge transfer on FIHR implementation.

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 […]

Third UNICOM Trans-Atlantic meeting

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, […]

Global PharmaceuticaL Regulatory Affairs Summit -Berlin

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:  

Community of expertise: Semantic specifications for eHealth services

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 […]

ePi HL7 Vulcan accelerator with UNICOM and GravitateHealth

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/

The UNICOM Innovation Action has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 875299.