BEGIN:VCALENDAR VERSION:2.0 PRODID:-//UNICOM - ECPv6.15.20//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-ORIGINAL-URL:https://unicom-project.eu X-WR-CALDESC:Events for UNICOM REFRESH-INTERVAL;VALUE=DURATION:PT1H X-Robots-Tag:noindex X-PUBLISHED-TTL:PT1H BEGIN:VTIMEZONE TZID:Europe/Berlin BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20200329T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20201025T010000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20210328T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20211031T010000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20220327T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20221030T010000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20230326T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20231029T010000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20240331T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20241027T010000 END:STANDARD END:VTIMEZONE BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD TZOFFSETFROM:+0000 TZOFFSETTO:+0000 TZNAME:UTC DTSTART:20190101T000000 END:STANDARD END:VTIMEZONE BEGIN:VTIMEZONE TZID:Europe/Paris BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20200329T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20201025T010000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20210328T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20211031T010000 END:STANDARD BEGIN:DAYLIGHT TZOFFSETFROM:+0100 TZOFFSETTO:+0200 TZNAME:CEST DTSTART:20220327T010000 END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:+0200 TZOFFSETTO:+0100 TZNAME:CET DTSTART:20221030T010000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;VALUE=DATE:20230124 DTEND;VALUE=DATE:20230125 DTSTAMP:20260501T141111 CREATED:20230105T111637Z LAST-MODIFIED:20230105T111654Z UID:9151-1674518400-1674604799@unicom-project.eu SUMMARY:Celebration day: Transfer of substance dataset to EMA and go-live of EU-SRS DESCRIPTION:  URL:https://unicom-project.eu/event/celebration-day-transfer-of-substance-dataset-to-ema-and-go-live-of-eu-srs/ LOCATION:AMSTERDAM CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230110T130000 DTEND;TZID=Europe/Berlin:20230110T140000 DTSTAMP:20260501T141111 CREATED:20230110T104906Z LAST-MODIFIED:20230110T104906Z UID:9156-1673355600-1673359200@unicom-project.eu SUMMARY:5th HL7 FHIR ePI Vulcan accelerator DESCRIPTION:Take part today at 13.00 in the 5TH  ePI Vulcan accelerator discussion with a joint input of both UNICOM – Up-scaling the global univocal identification of medicines and Gravitate Health\n-> All the detailed information about the track can be found here: https://lnkd.in/eD8x3TQu \nThis is the 5th  event in the series of companion events to Vulcan ePI Project HL7 FHIR Connectathon tracks that will take place in Nevada on 14-15 January\, 2023. \nThe vision of the Gravitate Health ePI /Vulcan accelerator ePI/ eLabeling project is to define a common structure for medicinal product information that improves the patient experience and supports interoperability across the international healthcare clinical and regulatory environment. URL:https://unicom-project.eu/event/5th-hl7-fhir-epi-vulcan-accelerator/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20221104T150000 DTEND;TZID=Europe/Berlin:20221104T163000 DTSTAMP:20260501T141111 CREATED:20221024T141028Z LAST-MODIFIED:20221024T141028Z UID:9051-1667574000-1667579400@unicom-project.eu SUMMARY:UNICOM Community of Expertise: SUBSTANCE and EU-SRS DESCRIPTION:The 4th of November a Community of Expertise will be held for which you have been invited. \nThe presenters will be Annet Rozema\, Mirjam Keulen & Marcel Hoefnagel from CBG\, The Netherlands\, UNICOM WP 2. \nSubstances have been the topic of the UNICOM Community of Expertise before and this is not a surprise as substances form one of the three pillars of medicinal product identification. Much progress has been achieved in the last twelve months \nUNICOM WP2 is tasked with setting up the EU Substance Registration System EU-SRS. \nThe EU-SRS team would like to share with you how the different substance types which are handled in EU-SRS; which fields are captured\, and howthe records are  structured. Therefore\, we provide a deep dive into the working of EU-SRS\, with a focus on explaining how Chemicals\, Polymers\, Proteins and Vaccines are handled in EU-SRS. We will show real examples of European substances records and explain some of the key choices made in how to build these records in EU-SRS. This will provide good insight in the capabilities of EU-SRS for use by the European regulatory network\, after go-live of the system. \n  \nModeration will be done by:  \nChristian Hay (UNICOM WP 1\, ISO/TC 215 WG6) \nRobert Stegwee (UNICOM WP 1\, CEN/TC 251) \n  \nRegistering for the event can be done by following the link: \nhttps://us02web.zoom.us/webinar/register/WN_FrC98CkUS_ynxEhx2BFgew \n  URL:https://unicom-project.eu/event/unicom-community-of-expertise-substance-and-eu-srs/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220826T150000 DTEND;TZID=Europe/Berlin:20220826T163000 DTSTAMP:20260501T141111 CREATED:20220510T101657Z LAST-MODIFIED:20220621T085516Z UID:8852-1661526000-1661531400@unicom-project.eu SUMMARY:Community of Expertise: Navigating global and national identifiers using IDMP and FHIR DESCRIPTION:The next UNICOM Community of Expertise is scheduled on Friday 26 August 2022: \nIn collaboration with the Gravitate Health project and the Vulcan Accelerator ePI project\, UNICOM has contributed to a track at the May HL7 FHIR Connectathon. The scenario being developed was on a travelling lady needing treatment to a recurring condition\, for which she knows which medication is effective in her home country. In addition to finding an equivalent medicinal product available locally (the UNICOM demonstrator case) she also wants to access the pertinent electronic product information (ePI) in her own language (the Gravitate Health case). This requires careful and safe navigation across the respective national identifiers of the medicinal products involved\, using the global linkage between them. This session highlights the choices and discussions taking place on the FHIR resources to be used and the services to be developed for these purposes. \nPresenters: Esther Peelen (UNICOM WP 1\, Nictiz)\n Craig Anderson (Gravitate Health\, Vulcan\, Pfizer)\n Leonora Grandia (UNICOM WPs 8 and 9\, Z-Index)\n Giorgio Cangioli (UNICOM WP 1\, HL7 Europe) \nPanelists: Jens Villadsen (Gravitate Health\, HL7 Europe\, Trifork)\n Hugh Glover (UNICOM FHIR IDMP Server\, Vulcan\, Blue Wave Informatics)\n Rik Smithies (EMA FHIR Consultant\, Vulcan\, NProgram)\n José Costa Teixeira (UNICOM WPs 1 and 6\, IHE Pharmacy) \nModerators: Christian Hay (UNICOM WP 1\, ISO/TC 215 WG6)\n Robert Stegwee (UNICOM WP 1\, CEN/TC 251) \nYou can register with the following link: https://us02web.zoom.us/webinar/register/WN_eIcAxPw4QmOYEwbugv5ObA URL:https://unicom-project.eu/event/community-of-expertise-unicom-demonstrator-idmp-to-support-patient-empowerment/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220621T110000 DTEND;TZID=Europe/Berlin:20220621T110000 DTSTAMP:20260501T141111 CREATED:20220531T125658Z LAST-MODIFIED:20220531T130637Z UID:8869-1655809200-1655809200@unicom-project.eu SUMMARY:National Competent Centers knowledge exchange webinar: Focus on Ireland DESCRIPTION:Those webinars are meant to facilitate an early and detailed cross-fertlisation between European National Competent Authorities. \nIreland (HPRA) will be presnting its current sttaus on its road toward IDMP implementation. \nAll staff of all European agencies are warmly welcome to attend. \nIf you have not received an invitation but would like to attend\, please send a mail to unicom@ehtel.eu \nif you are not part of a NCA but have specific interest in participating\, explain it shortly in a mail to unicom@ehtel.eu URL:https://unicom-project.eu/event/national-competent-centers-knowledge-exchange-webinar-focus-on-ireland/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220516T100000 DTEND;TZID=Europe/Berlin:20220516T120000 DTSTAMP:20260501T141111 CREATED:20220510T101227Z LAST-MODIFIED:20220510T101746Z UID:8850-1652695200-1652702400@unicom-project.eu SUMMARY:DADI-PMS Webinar: Variations Form for Human Medicinal Products - What will happen at Go-Live DESCRIPTION:REGISTER URL:https://unicom-project.eu/event/dadi-pms-webinar-variations-form-for-human-medicinal-products-what-will-happen-at-go-live/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220422T150000 DTEND;TZID=Europe/Berlin:20220422T163000 DTSTAMP:20260501T141111 CREATED:20220405T071631Z LAST-MODIFIED:20220414T161717Z UID:8799-1650639600-1650645000@unicom-project.eu SUMMARY:Community of expertise: Semantic specifications for eHealth services DESCRIPTION:Semantic specifications for eHealth services \nThis 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 for changes proposed to the eHealth Digital Service Infrastructure. This webinar will dive deeper into: \nThe goal and requirements of semantic specifications (Anderson Carmo and José Costa Teixeira)\nThe use and importance of semantic specifications for Medicinal Product Dictionaries (Robert vander Stichele)\, Myhealth@EU (Frederic Bulckaen) and how it will initiate change proposals for eHDSI (Mathias Ghys). \nThe presentation of this selection of requirements will be commented by other stakeholders such as from industry\, national competent authorities and medicinal product dictionaries (MPD)\, which play a critical role in the medicinal product life cycle as described in diverse UNICOM WP1 deliveries. \n  \nSpeakers:                            \nAnderson Carmo (SPMS\, WP5)\nJosé Costa Teixeira (IHE\, WP1\, WP5)\nRobert vander Stichele (WP1\, WP9)\nFrederic Bulckaen (EC)\nMathias Ghys (EC) \n  \nPanelists:                            \nJean-Gonzague Fontaine (GSK vaccines)\nMarcello Melgara (ARIA\, WP 5\, WP 6 and WP7) \n  \nModeration:                     \nChristian Hay (GS1\, ISO TC 215/WG6 and UNICOM WP1) \nRobert Stegwee (CEN TC 251 and UNICOM WP1) \n  \nRegistration:                     You can register via the following link: Webinar Registration – Zoom URL:https://unicom-project.eu/event/community-of-expertise-semantic-specifications-for-ehealth-services/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220318T140000 DTEND;TZID=Europe/Berlin:20220318T160000 DTSTAMP:20260501T141111 CREATED:20220307T101107Z LAST-MODIFIED:20220307T102154Z UID:8758-1647612000-1647619200@unicom-project.eu SUMMARY:EMA SPOR Webinar: Webinar on requesting access to and using EMA's substance\, product\, organisation and referential (SPOR) application programming interface (API) DESCRIPTION:Date: 18/03/2022 \nLocation: Online\, 14:00 – 16:00 Amsterdam time (CEST) \n\nHow to request access to SPOR API\nWhere to find SPOR help and support\nSPOR API resources and concepts\nSPOR API demo\nSPOR API tips for better use/querying\n\nRegistration URL:https://unicom-project.eu/event/ema-spor-webinar-webinar-on-requesting-access-to-and-using-emas-substance-product-organisation-and-referential-spor-application-programming-interface-api/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220310T100000 DTEND;TZID=Europe/Berlin:20220310T160000 DTSTAMP:20260501T141111 CREATED:20220307T100758Z LAST-MODIFIED:20220307T100758Z UID:8756-1646906400-1646928000@unicom-project.eu SUMMARY:EMA SPOR webinar: Introduction to the Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users. DESCRIPTION:This webinar is an introduction to the Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users. \nThe morning session\, from 10:00 to 11:30\, is dedicated to RMS: \n\nIntroduction to RMS\nRMS processes: Data Stewardship (CRs\, deltas ) and Service Desk\nRMS Statistics: CRs & SLAs\, Service Desk & SLAs\, Customer satisfaction survey\nChange Request process – Main issues with CRs and tips\nRMS in Projects/Systems – what projects in 2022 and how it affects users\nCurrent and future RMS Activities\nQ&A Session\n\nFrom 11.30-12.00 the session focuses on the Improvements on the EMA Account Management system \n\nReduction of steps to register new users: Form simplification and new roles as birth rights\nImproved security features: captchas and Token\n\nThe afternoon session\, from 14:00 to 16:00\, focuses on OMS: \n\nOMS Introduction & Key principles\nOMS processes: Data Stewardship (CRs\, deltas) and Service Desk\nOMS Statistics: CRs & SLAs\, ETL Service Desk & SLAs\, Customer satisfaction survey\nData Quality management\nChange Request process – Main issues with CRs and tips\nService Desk\nOMS in Projects/Systems – what projects in 2022 and how it affects users\nCurrent and future OMS Activities\nQ&A Session\n\nRegistration\n  URL:https://unicom-project.eu/event/ema-spor-webinar-introduction-to-the-organisation-management-service-oms-and-referentials-management-service-rms-services-and-activities-for-industry-users/ CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2021/02/logo-ema.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220125T103000 DTEND;TZID=Europe/Berlin:20220125T120000 DTSTAMP:20260501T141111 CREATED:20211215T092442Z LAST-MODIFIED:20211215T092619Z UID:8265-1643106600-1643112000@unicom-project.eu SUMMARY: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) DESCRIPTION: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. \nDespite the focus on human medicines\, all stakeholders interested in the technical aspects of the FHIR message are welcome. \nTopics addressed in this webinar include the: \n\nFHIR data standard and its use in electronic application\nconceptual model of the FHIR message for human medicines’ variations forms\nPMS data model and how it links to DADI\n\nMore INFO \nAGENDA \nREGISTER for this event URL:https://unicom-project.eu/event/digital-application-dataset-integration-dadi-webinar-common-factors-in-the-fast-healthcare-interoperability-resources-fhir-data-standard-for-article-572-and-electronic-application-forms-eaf/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220118T103000 DTEND;TZID=Europe/Berlin:20220118T120000 DTSTAMP:20260501T141111 CREATED:20211215T091255Z LAST-MODIFIED:20211215T093407Z UID:8263-1642501800-1642507200@unicom-project.eu SUMMARY:Introducing DADI: webinar on the digital application dataset integration (DADI) network project to replace electronic application forms DESCRIPTION: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. \nThis first public webinar is for stakeholders from the human & veterinary medicines industry and national competent authorities wishing to learn more about the following: \n\nDADI roadmap & objectives for CAPS & NAPS\nDADI’s connection to EMA’s Regulatory Business Optimisation\nMain changes introduced by DADI and impacts for the pharmaceutical industry\n\nMore info: Under this link \nREGISTER FOR THIS EVENT URL:https://unicom-project.eu/event/introducing-dadi-webinar-on-the-digital-application-dataset-integration-dadi-network-project-to-replace-electronic-application-forms/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20211104T090000 DTEND;TZID=Europe/Berlin:20211104T120000 DTSTAMP:20260501T141111 CREATED:20211019T094419Z LAST-MODIFIED:20211019T094419Z UID:8146-1636016400-1636027200@unicom-project.eu SUMMARY:Annual workshop about lessons learnt (UNICOM NCAs) DESCRIPTION:This is a closed event.\nWe already had presentation from a number of partners and this time we kindly invite:\n– BfARM (DE)\n– ARMPS (BE)\n– INFARMED (PT)\nto present lessons learnt from their view. \nWe also invite ALL partners to share experiencies during the discussion. URL:https://unicom-project.eu/event/annual-workshop-about-lessons-learnt-unicom-ncas/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210827T150000 DTEND;TZID=UTC:20210827T163000 DTSTAMP:20260501T141111 CREATED:20210709T075301Z LAST-MODIFIED:20210806T084431Z UID:7598-1630076400-1630081800@unicom-project.eu SUMMARY:Community of Expertise: Substance identification using INN and ATC – governance\, use\, and relation to IDMP DESCRIPTION: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. \nPresenters: \nDr Rafaella Balocco (WHO\, Geneva ) \nChristian Lie Berg (UNICOM WP 1\, WHO-DSM\, Oslo ) \nPanelists: \nAntonio Romeo (WHO) \nRobert Vander Stichele (UNICOM WP 1\, i~HD) \nOlof Lagerlund (UNICOM WP 1\, WHO-UMC) \nModerators: \nChristian Hay (UNICOM WP 1\, GS1 and ISO TC 215/WG6) \nRobert Stegwee (UNICOM WP 1\, CEN TC 251) \n\nREGISTER URL:https://unicom-project.eu/event/community-of-exepertise-substance-identification-using-inn-and-atc-governance-use-and-relation-to-idmp/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210629T150000 DTEND;TZID=UTC:20210629T163000 DTSTAMP:20260501T141111 CREATED:20210609T091937Z LAST-MODIFIED:20210625T111353Z UID:7434-1624978800-1624984200@unicom-project.eu SUMMARY:Community of expertise: Cross-border ePrescription - standards\, terminologies\, processes DESCRIPTION:UNICOM – Cross-border ePrescription – standards\, terminologies\, processes\n\n\n\nYou 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 for the MyHealth@EU services as provided by the eHealth Digital Service Infrastructure (eHDSI). In this Community of Expertise we will present on the current standards\, terminologies and processes for cross-border services and our progress in developing change proposals to make optimal use of the IDMP implementation. We also provide a platform for discussion on the way forward.\n\n \n\nParticipation is open to everybody but preliminary registration is requested.\n\n \n\nTime: 3:00 – 4:30 pm CEST\n\n \n\nPresenters:  \n\n \n\nAnderson Carmo (UNICOM- SMPS Portugal)\n\n \n\nAlexander Berler (UNICOM – GNOMON Greece)\n\n \n\nMarcello Melgara (UNICOM – REGLOM Italy)\n\n \n\nPanelists:\n\n \n\nChristoph Gessner (eHDSI Member State Expert Group)\n\n \n\nJosé Costa Teixeira (UNICOM WP 1 and IHE Pharmacy)\n\n \n\nModerators:  \n\n \n\nEsther Peelen (UNICOM WP1- NICTIZ) \n\n \n\nRobert Stegwee (UNICOM WP1- CEN TC 251) \n\n\n\nRegistration is open: https://us02web.zoom.us/webinar/register/WN_4fmL4BHWQJCZ0U0r-I5Ihg​ URL:https://unicom-project.eu/event/community-of-expertise-cross-border-eprescription-standards-terminologies-processes/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210615T150000 DTEND;TZID=UTC:20210615T153000 DTSTAMP:20260501T141111 CREATED:20210609T091533Z LAST-MODIFIED:20210609T091533Z UID:7432-1623769200-1623771000@unicom-project.eu SUMMARY:UNICOM presentation at IHE-Europe Experience DESCRIPTION:IDMP  in Europe – what does it mean for you? \nPresentation by Robert Stegwee \nFree registration at: https://connectathon.ihe-europe.net/experience-sessions-tuesday-15-june​ URL:https://unicom-project.eu/event/unicom-presentation-at-ihe-europe-experience/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210608T150000 DTEND;TZID=UTC:20210608T170000 DTSTAMP:20260501T141111 CREATED:20210603T082957Z LAST-MODIFIED:20210603T082958Z UID:7422-1623164400-1623171600@unicom-project.eu SUMMARY:First UNICOM transatlantic meeting DESCRIPTION:​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. \nThe 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 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 actively promote a common vision for IDMP and other relevant data standards adoption on an international scale. \nWe have planned the following agenda: \n\nWelcome\, introduction to CTADHL and UNICOM (Vada Perkins\, Frits Stulp and Christian Hay)\nOpening remarks (US FDA speaker-TBD)\nUS FDA perspective: current activities (Ron Fitzmartin – TJ Chen-US Food and Drug Administration)\nEMA perspective: SPOR (Isabel Chicharo – European Medicines Agency)\nThe global perspective (Malin Fladvad – WHO-Uppsala Monitoring Centre)\nImpact on international standards (Mike Glickman\, Christian Hay – ISO)\nClosing remarks (Stan van Belkum – Central Committee on Research Involving Human Subjects)​ URL:https://unicom-project.eu/event/first-unicom-transatlantic-meeting/ LOCATION:Virtual CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210602T160000 DTEND;TZID=UTC:20210602T170000 DTSTAMP:20260501T141111 CREATED:20210602T140451Z LAST-MODIFIED:20210603T083702Z UID:7378-1622649600-1622653200@unicom-project.eu SUMMARY:IDMP: Webinar about Pharmaceutical Products for UNICOM partners and NCAs DESCRIPTION: URL:https://unicom-project.eu/event/idmp-webinar-about-parmaceutical-products-for-unicom/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210528T150000 DTEND;TZID=UTC:20210528T163000 DTSTAMP:20260501T141111 CREATED:20210518T101413Z LAST-MODIFIED:20210519T094859Z UID:7313-1622214000-1622219400@unicom-project.eu SUMMARY:UNICOM Community of Expertise: Representation of clinical information related to medication using SNOMED CT and other standards DESCRIPTION:UNICOM – Representation of clinical information related to medication using SNOMED CT and other standards\nThis 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 record system to populate an individual case safety report (ICSR) in case of an adverse reaction to medication. MedDRA and EDQM Standard Terms are the terminologies of choice for the ICSR. The objective of the webinar is to identify and better understand the need for coordination across standards with respect to the representation of clinical information. This includes the use of mappings between different terminologies and value sets as required in different domains and the efforts needed to maintain such mappings. \nPresenters: \nJane Millar (SNOMED International\, WP 1) \nIan Green (SNOMED International) \nSarah El Amin ​(MHRA)​ \nPanelist: \nToni Morrison (SNOMED International)\nBarry Hammond (MedDRA\, WP 1)\nChris Jarvis (EDQM\, WP 1)\nKate Bateman (MHRA) \nModerators: \nChristian Hay (GS1 and ISO TC 215/WG6\, WP 1)\nRobert Stegwee (CEN TC 251 – WP 1) \n  \nYou can already register with the following link: https://us02web.zoom.us/webinar/register/WN_qymogaTSSq6tPIGKu9clcA \n  URL:https://unicom-project.eu/event/unicom-community-of-expertise-representation-of-clinical-information-related-to-medication-using-snomed-ct-and-other-standards/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210504T160000 DTEND;TZID=UTC:20210504T170000 DTSTAMP:20260501T141111 CREATED:20210603T043002Z LAST-MODIFIED:20210603T043122Z UID:7391-1620144000-1620147600@unicom-project.eu SUMMARY:Essential information about IDMP and UNICOM​ Status of IDMP implementation at NCAs​ Special topic- Ingredients DESCRIPTION: URL:https://unicom-project.eu/event/essential-information-about-idmp-and-unicom%e2%80%8b-status-of-idmp-implementation-at-ncas%e2%80%8b-special-topic-ingredients/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210429T160000 DTEND;TZID=UTC:20210429T170000 DTSTAMP:20260501T141111 CREATED:20210603T043335Z LAST-MODIFIED:20210603T043349Z UID:7395-1619712000-1619715600@unicom-project.eu SUMMARY:IDMP: Webinar about Manufactured Items and Packages for UNICOM partners and NCAs DESCRIPTION: URL:https://unicom-project.eu/event/idmp-webinar-about-manufactured-items-and-packages-for-unicom-partners-and-ncas/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210429T150000 DTEND;TZID=UTC:20210429T163000 DTSTAMP:20260501T141111 CREATED:20210413T060944Z LAST-MODIFIED:20210419T141545Z UID:7119-1619708400-1619713800@unicom-project.eu SUMMARY:UNICOM Community of Expertise: Medicinal Product Dictionaries\, Medicinal Product Dictionaries\, ATC\, Melclass DESCRIPTION: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 task. In addition to the IDMP standards\, and as an example of supplementary sources of data\, we will also highlight the possible use of the Melclass database on the classification of medicines and their supply conditions (maintained by EDQM)\, as well as the ATC (and DDD) classification as maintained by the WHO-CC for Drugs Statistics Methodology. Join the discussion on how these different sources of data come together in a medicinal product dictionary! ​ \nPresenters: \nLeonora Grandia (Z-Index)\nUrsula Tschorn (Pharmazie.com)\nFrançois-Xavier Lery (EDQM)\nChristian Lie Berg (FHI)\nMarkus Pongratz (AGES) – Melclass Expert \nPanelists: \nModerators: \nChristian Hay (GS1 and ISO TC 215/WG6 – WP 1)\nRobert Stegwee (CEN TC 251 – WP 1)\n \nLink to Zoom Conference: \nlink: https://us02web.zoom.us/webinar/register/WN_9NTL4DyaQBCgruwV_NAdRg URL:https://unicom-project.eu/event/unicom-community-of-expertise-medicinal-product-dictionary/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210421T100000 DTEND;TZID=UTC:20210421T233000 DTSTAMP:20260501T141111 CREATED:20210326T073326Z LAST-MODIFIED:20210401T133433Z UID:6714-1618999200-1619047800@unicom-project.eu SUMMARY:UNICOM eHealth STAKEHOLDERS Outreach Webinar DESCRIPTION: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 \nDownload PDF \nRegister NOW URL:https://unicom-project.eu/event/unicom-ehealth-stakeholders-outreach-webinar/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210325T160000 DTEND;TZID=UTC:20210325T170000 DTSTAMP:20260501T141111 CREATED:20210603T043204Z LAST-MODIFIED:20210603T043204Z UID:7393-1616688000-1616691600@unicom-project.eu SUMMARY:Best practice workshop on IDMP/Ingredient​ DESCRIPTION: URL:https://unicom-project.eu/event/best-practice-workshop-on-idmp-ingredient%e2%80%8b/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20210224T140000 DTEND;TZID=UTC:20210224T151000 DTSTAMP:20260501T141111 CREATED:20210302T170310Z LAST-MODIFIED:20210302T170837Z UID:6677-1614175200-1614179400@unicom-project.eu SUMMARY:International pharmaceutical regulators programme DESCRIPTION:​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) ​ URL:https://unicom-project.eu/event/international-pharmaceutical-regulators-programme/ CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Paris:20210223T170000 DTEND;TZID=Europe/Paris:20210223T183000 DTSTAMP:20260501T141111 CREATED:20210210T175055Z LAST-MODIFIED:20210210T175523Z UID:6618-1614099600-1614105000@unicom-project.eu SUMMARY:Joint Initiative Council Open Forum DESCRIPTION: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 at the right time for high-quality decisions and care. \nAfternoon Session – Enabling the digital transformation of healthcare \nAEDT 3am-4:30am | PST 8am-09:30am | EST 11am-12:30pm | CET 5pm-6:30pm \n\nIntroduction – Mike Nussbaum\, past chair\, IHE International\nCOVID-19 case – Speaker to be confirmed\nInternational Patient Summary (IPS) – Robert Hausman\, HL7 International and Steve Kay\, CEN TC 251\nIdentification of Medicinal Products (IDMP) – Speaker to be confirmed\nGenomics – Bron Kisler\, ISO TC 215\, SC 1​ URL:https://unicom-project.eu/event/joint-initiative-council-open-forum/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2020/11/Make-Things-Happen-Board-1200.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Paris:20210223T070000 DTEND;TZID=Europe/Paris:20210223T083000 DTSTAMP:20260501T141111 CREATED:20210211T061616Z LAST-MODIFIED:20210211T074200Z UID:6620-1614063600-1614069000@unicom-project.eu SUMMARY:JIC Open Forum Global Webinar DESCRIPTION:Joint Initiative Council Open Forum – Morning Session \nTranscending 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 at the right time for high-quality decisions and care. \nMorning Session – Enabling the digital transformation of healthcare \nAEDT 5pm-6:30pm |PST 10pm-11:30pm | EST 1am-2:30am | CET 7am-8:30am \n\nIntroduction – Ulrike Kreysa\, Chair JIC\, GS1 Global Office\, Belgium\nCOVID-19 case – Jane Millar\, SNOMED International\, UK\nInternational Patient Summary (IPS) – Robert Stegwee\, CEN TC 251 and Catherine Chronaki\, HL7 Europe\nIdentification of Medicinal Products (IDMP) – Christian Hay\, Sr consultant Healthcare\, GS1 Global Office\, and ISO TC 215\, Switzerland\nGenomics – Speaker to be confirmed​ URL:https://unicom-project.eu/event/jic-open-forum-global-webinar/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Paris:20210219T150000 DTEND;TZID=Europe/Paris:20210219T163000 DTSTAMP:20260501T141111 CREATED:20210205T092255Z LAST-MODIFIED:20210216T091615Z UID:6583-1613746800-1613752200@unicom-project.eu SUMMARY:UNICOM Community of Expertise - IDMP Logical Model DESCRIPTION:UNICOM – IDMP Logical Model\nThe 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.​ \nRegister here: https://us02web.zoom.us/webinar/register/WN_ND_oxTJnQJmAa6vBFjMnJQ URL:https://unicom-project.eu/event/unicom-community-of-expertise-idmp-logical-model/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2021/02/logical-model.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Paris:20210122T150000 DTEND;TZID=Europe/Paris:20210122T163000 DTSTAMP:20260501T141111 CREATED:20210108T161316Z LAST-MODIFIED:20210108T161932Z UID:6537-1611327600-1611333000@unicom-project.eu SUMMARY:UNICOM Community of Expertise - Pharmaceutical Dose Forms DESCRIPTION:​UNICOM – Pharmaceutical Dose Forms \nThe 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. URL:https://unicom-project.eu/event/unicom-community-of-expertise-pharmaceutical-dose-forms/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2021/01/pexels-pixabay-159211-scaled.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Paris:20210121T140000 DTEND;TZID=Europe/Paris:20210121T153000 DTSTAMP:20260501T141111 CREATED:20210118T094242Z LAST-MODIFIED:20210118T103559Z UID:6557-1611237600-1611243000@unicom-project.eu SUMMARY:20th Regulatory Affairs and Pharmacovigilance webinar DESCRIPTION:How digitalisation can support the regulatory business process\n​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 \nRemco Munnik\, Chair of the Telematics WG Medicines for Europe\, Iperion – Open dialogue between industry and regulators: How digitalisation can support the regulatory objectives in the pharmaceutical strategy and what are the concrete steps to move forward? \nPanel Speakers: \n\nHilmar Hamann\, Head of Information Management Division\, EMA\nHarald von Aschen\, Chair of the IT Directors Executive Committee\, BfArM (DE)\nJoris Kampmeijer\, Chief Information Officer\, MEB (NL)\nPeter Bachmann\, Head International Liaison Office and Conferences\, BfArM (DE)\nGeorg Neuwirther\, Head of IT\, AGES (AT)\n\nMore information and registration on https://www.medicinesforeurope.com/events/racphv2021/ URL:https://unicom-project.eu/event/20th-regulatory-affairs-and-pharmacovigilance-webinar/ LOCATION:Virtual CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2021/01/medicinesforeurope_logo.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=UTC:20201204T150000 DTEND;TZID=UTC:20201204T163000 DTSTAMP:20260501T141111 CREATED:20201125T095753Z LAST-MODIFIED:20210108T154058Z UID:6466-1607094000-1607099400@unicom-project.eu SUMMARY:Upcoming UNICOM Community of Expertise Webinar: IDMP supporting COVID-19 immunization DESCRIPTION:The UNICOM monthly\, interactive Community of Expertise webinar  sessions address issues related to the identification of  medicinal products (IDMP)  in regulatory and clinical contexts.  \nOn Friday\, 4 December\, UNICOM holds the fifth CoE webinar addressing how IDMP is supporting COVID-19 immunization: \n\nA number of new vaccines will arrive on the market with the purpose to immunize a large number of people against COVID-19 virus.\nPurpose for this webinar is to explore how much IDMP supports the near-future immunizations – from marketing authorisation\, labelling\, preparedness for adverse event processing and validation\, to pharmaco-economic analysis.\n\nPresenters: \n\nMirjam Sturkenboom (VACC4EU)\nAnja van Haren (CBG\, WP3)\nMalin Fladvad (WHO-UMC\, WP1)\n\nPanellist: Robert Vander Stichele (University Gent\, I~HD\, WP8) \nModerator: Christian Hay and Robert Stegwee  (WP1) \nZOOM-link: Please register (obligatory) for this webinar at  https://us02web.zoom.us/webinar/register/WN_wI9lN_v7QRmsYISptipVow \n(first come\, first served: If number of attendees exceeds 100\, you will receive a link to follow the webinar in streaming mode on Youtube; that link will only be sent to registered participants).  \nPrevious webinars are now available on the UNICOM YouTube channel:  \n\nIDMP\, Falsified Medicines Directive and Parallel Trade. \nUNICOM – The PhPID (Unique identification for Pharmaceuticals products) \nUNICOM – Gap Analysis about existing and new standards and profiles  URL:https://unicom-project.eu/event/unicom-community-of-expertise-webinar-idmp-supporting-covid-19-immunization/ LOCATION:Online Event – URL on Registration CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2020/11/COVID.png END:VEVENT END:VCALENDAR