BEGIN:VCALENDAR VERSION:2.0 PRODID:-//UNICOM - ECPv6.15.20//NONSGML v1.0//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:UNICOM 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:20200101T000000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20231013T100000 DTEND;TZID=Europe/Berlin:20231013T120000 DTSTAMP:20260501T125155 CREATED:20230126T103807Z LAST-MODIFIED:20230531T095700Z UID:9196-1697191200-1697198400@unicom-project.eu SUMMARY:Advanced FHIR training: How to import application form data into IT systems DESCRIPTION:REGISTER NOW FOR THIS EVENT \n\n\n\n\nAdvanced FHIR training: How to track changes on a medicinal product?\nUNICOM is happy to invite all of you to the 4th NCA FHIR training on October 13 10-12 CEST.\n\nThis webinar focus topic is: “How to track changes on a medicinal product?”\n“Provenance” in the Variation FHIR message: \n\nFree text changes\nOrganisation changes\nMedicinal Product changes (IDMP fields)\n\nFor your personal convenience\, we provide you here below with the links to the videos of the three previous FHIR related trainings. \n►Get an overview of the full product:FHIR Training: The Medicinal Product part of FHIR\n–> (recording) <– \n►Get an overview of the variation message: FHIR Training: FHIR on Variations\n–> (recording) <– \n  \n►Top 10 most wanted IDMP fields: FHIR Training: Top 10 IDMP fields through XPath\n–> (recording) <– \n\nFri\, Oct 13\, 10:00 AM – 12:00 PM (CEST)\n  URL:https://unicom-project.eu/event/advanced-fhir-training-how-to-import-application-form-data-into-it-systems/ LOCATION:Online Event – URL on Registration CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2021/05/fihr-connecthaton.png END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20230928 DTEND;VALUE=DATE:20230929 DTSTAMP:20260501T125155 CREATED:20230407T142518Z LAST-MODIFIED:20230921T090228Z UID:9249-1695859200-1695945599@unicom-project.eu SUMMARY:UNICOM day IHE Connectathon in Rennes DESCRIPTION:In the context of the IHE-Europe Connectathon WEEK 2023 | Connectathon in Rennes France and in parrallel to the French eHealth week. \nLooking across the landscape of IDMP implementation\, the UNICOM project aims to develop the following testing scenarios as part of the UNICOM Test Lab:\n• Submission of variations\nWhen a pharmaceutical company needs to apply for market authorization for a variation of an already authorized medicinal product\, how can a FHIR/IDMP-compliant exchange of information with the appropriate national competent authority (NCA) support such an application?\n• Updates to the MPD\nWhen changes to the national list of authorized medicinal products are published by the local NCA\, how can a FHIR/IDMP-compliant exchange of information facilitate the updates in the local Medicinal Product Dictionaries (MPDs)? And how are they made available to the variety of clinical systems using the MPD data?\n• Updates to the NCPeH product database\nWhen changes to the national list of authorized medicinal products are published by the local NCA\, how can a FHIR/IDMP-compliant exchange of information facilitate the updates in the product database for cross-border ePrescribing and Dispensing\, as needed by the National Contact Point for eHealth (NCPeH)\n• Including substitution in eDispensation\nHow does the local pharmacy apply substitution rules\, based on the CDA/IDMP-compliant data in a cross-border ePrescription\, and communicate the actual dispensed medication back in the CDA/IDMPcompliant dispensation record?\n• Product lookup for patient facing apps\nHow can a patient use a FHIR/IDMP-compliant multilanguage representation of over-the-counter (OTC) medication to safely substitute their common medication by the locally available brand\, checking for intolerances and interactions? \nEach team will present the highlights of their work during the in-person UNICOM Day on September 28\, 2023 in Rennes\, France. The objective is to further develop the testing strategy in conjunction with IHE Europe\, to make sure that conformance with IDMP related standards and terminologies can be systematically tested in the future\, even when the UNICOM project has finished. \nHere is the agenda of the day: \n \nWe encourage you to register without delay  for the UNICOM Day in Rennes\, France on SEPTEMBER 28 through THIS LINK  URL:https://unicom-project.eu/event/unicom-ihe-hachathon/ LOCATION:Rennes\, France CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2020/02/ihe-3.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230915T150000 DTEND;TZID=Europe/Berlin:20230915T163000 DTSTAMP:20260501T125155 CREATED:20230904T080033Z LAST-MODIFIED:20230912T121642Z UID:9409-1694790000-1694795400@unicom-project.eu SUMMARY:UNICOM Community of Expertise: Global alignment on substances based on the ISO IDMP and the SRS software DESCRIPTION:A  report on progress and challenges from the Global IDMP Working Group (GIDWG)\, about substances. \nThe presentation will give an overview of the GIDWG work on global alignment of substances\, the role of a global substance ID in the medicinal product lifecycle and the challenges faced. \nThe presentation will also demonstrate how a new resource for substances could be requested using a FHIR Task in an asynchronous process that may or may not involve human interaction and demonstrate how the resource for substances will look\, and can be used as references from other resources such as EU-SRS. \n  \nPresenters: \nOlof Lagerlund\, Magnus Wallberg (WHO-UMC) \nMagnus Wallberg [WHO-UMC} \nAnnet Rozema (or colleague) (EU-SRS team at CBG/MEB) \n  \nPanellist: \nRobert Vander Stichele (i~HD) \nMonica Harry (SNOMED International) \nNorman Schmuff (FDA) \nModerators: \nChristian Hay\, UNICOM WP1\, ISO/TC 215 WG6 Pharmacy and Medicines Business\, GS1 \nRobert Stegwee\, UNICOM WP1\, CEN TC 251 \n  \nRegistration: CLICK HERE URL:https://unicom-project.eu/event/unicom-community-of-expertise-global-alignment-on-substances-based-on-the-iso-idmp-and-the-srs-software/ LOCATION:Virtual CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2023/01/EU-SRS-Logo-full.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230626T140000 DTEND;TZID=Europe/Berlin:20230626T153000 DTSTAMP:20260501T125155 CREATED:20230330T160412Z LAST-MODIFIED:20230331T111336Z UID:9235-1687788000-1687793400@unicom-project.eu SUMMARY:Knowledge transfer webinar: SPAIN in Focus DESCRIPTION:You may already REGISTER URL:https://unicom-project.eu/event/knowledge-transfer-webinar-spain-in-focus/ LOCATION:Virtual CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2023/03/aemps.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230530T143000 DTEND;TZID=Europe/Berlin:20230530T160000 DTSTAMP:20260501T125155 CREATED:20230407T142207Z LAST-MODIFIED:20230531T094601Z UID:9242-1685457000-1685462400@unicom-project.eu SUMMARY:Putting resources developed by UNICOM to the test: Preparing the UNICOM IHE Connecthathon DESCRIPTION:This webinar is targeted at all European NCAs\, eHealth competence centers and Industry (EMR\, MPDs\, HCP and Patient facing Apps). It will present and discuss the approach porposed by IHE to test and validate IDMP data (using UNICOM resources). The result of this webinar will feed the content of the IHE hacktathon which will take pkace in Rennes (France) on September 28th. \nIHE-Europe Connectathon WEEK 2023 | Connectathon. \nWATCH THE WEBINAR\nMore info: \nUNICOM Work Packages 6 and 1 are pleased to announce an upcoming webinar 30 May 14:30-16:00 CET. This webinar will prelude the UNICOM Day\, taking place 28 September 2023\, during the IHE Europe Connectathon week in Rennes\, France.  \n Join us to find out how the IHE structured and globally proven way of testing will help you to get your systems seamlessly communicating with the ones of your partners. Together with you we will define the testing scenario’s that will actually facilitate interoperability and conformance testing with IDMP.  \n  \nTest Lab \nThe 30 May webinar will set off the UNICOM Test Lab calendar and the Test Lab scenario’s. With guidance of WP6 and WP1 you will be creating the testing scenario’s that will be piloted the next months. UNICOM Software factory in WP6 has developed several components that will get you started! \nTogether we will present and discuss the results of the test lab experience during the UNICOM Day September 28. \n Are you working at an NCA\, the Pharma Industry\, a Medicinal Product Dictionary Provider\, an eHealth agency\, an EHR vendor or a Patient app provider and involved in IDMP implementation? Then this webinar is for you! \n Of course there will be plenty of opportunity to address your questions. We encourage all those interested in testing their implementation of IDMP-identifiers and attributes to attend this webinar on the 30th of May at 14h30.” \nFootnote: the two-day event ‘IHE-Europe Experience Days’ will take place 26 and 27 September. You might want to take the opportunity to get updated on all relevant European and Global developments in interoperability in Healthcare! Just have a look at the programme and registration details here. URL:https://unicom-project.eu/event/putting-resources-developed-by-unicom-to-the-test-preparing-the-unicom-ihe-hechtaton/ LOCATION:Rennes\, France CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230530T100000 DTEND;TZID=Europe/Berlin:20230530T113000 DTSTAMP:20260501T125155 CREATED:20230508T093917Z LAST-MODIFIED:20230508T095017Z UID:9294-1685440800-1685446200@unicom-project.eu SUMMARY:EMA Product Management Service (PMS) progress webinar DESCRIPTION:Public webinar intended for business\, developers and technical audiences working for industry and national competent authorities that are interested in learning more about the Product Management Service (PMS) development progress and related activities. \nPMS aims to deliver comprehensive and consolidated human medicinal product data (Centrally Authorised Products (CAPs) and Non-CAPs) from different sources. \nThe webinar will be an occasion for the audience to meet the PMS product owners\, ask questions and learn more about the deliverables achieved to support web-based electronic Application Forms (eAFs) as well as the planned PMS activities driving the implementation of ISO standards for the identification of medicinal products (IDMP) in the EU/EEA. URL:https://unicom-project.eu/event/ema-product-management-service-pms-progress-webinar/ LOCATION:Virtual 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:20230524T120000 DTEND;TZID=Europe/Berlin:20230524T133000 DTSTAMP:20260501T125155 CREATED:20230330T155955Z LAST-MODIFIED:20230330T172720Z UID:9233-1684929600-1684935000@unicom-project.eu SUMMARY:Knowledge transfer Webinar: Norway (NOMA) in focus DESCRIPTION:Central thema: Administrable products :  Based on relationship between manufactured and administrable dose form\, – NoMA’s solution to meet needs in clinical practice. \nREGISTER URL:https://unicom-project.eu/event/knowledge-transfer-webinar-norway-noma-in-focus/ LOCATION:Virtual CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2020/03/NoMA_logo-scaled.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230421T150000 DTEND;TZID=Europe/Berlin:20230421T163000 DTSTAMP:20260501T125155 CREATED:20230324T180216Z LAST-MODIFIED:20230324T180326Z UID:9220-1682089200-1682094600@unicom-project.eu SUMMARY:Community of Expertise: IDMP data : from source to final use DESCRIPTION:Description:\nReferring to the landscape of medicinal product data – from “research and development” to “utilisation and outcome assessments”- the vision is that the essential IDMP identifiers remain used and unchanged along that life cycle. \nThis Community of Expertise (CoE) will provide opportunity :\nfor industry to present their perspective and needs\, with large international companies\, with SME facing IT investments to implement IDMP\, and with advisers supporting IDMP implementation in companies and organisations;\nfor Medicinal Product Dictionaries suppliers\, with their the hub function between pharmaceutical companies\, National Competent Authorities\, on one hand\, and for their customers in the clinical space on the other hand;\nand for the consumption of these data with Pharmacovigilance. \nPresenters:\nQuentin Darrasse\, Roche Pharma\nAndreas Franken\, BAH\nStefan Peev\, NNIT\nFrederic Doc\, Vidal\nBoukje Raemaekers\, WHO-UMC \nPanellist:\nMalin Fladvad\, WHO-UMC \nModerators:\nChristian Hay\, UNICOM WP1\, ISO/TC 215 WG6 Pharmacy and Medicines Business\, GS1\nRobert Stegwee\, UNICOM WP1\, CEN TC 251 \nRegister here URL:https://unicom-project.eu/event/community-of-expertise-idmp-data-from-source-to-final-use/ LOCATION:Webinar via Zoom CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2022/07/picture-WP1-e1657728267149.jpg END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20230417 DTEND;VALUE=DATE:20230421 DTSTAMP:20260501T125155 CREATED:20230329T134208Z LAST-MODIFIED:20230329T134208Z UID:9227-1681689600-1682035199@unicom-project.eu SUMMARY:EMA WEBINAR WEEK DESCRIPTION:►You can register for the relevant Webinar by selecting the link below: \n\nSPOR and XEVMPD Data Governance – 17 April\, 10:00-12:00 CET – https://ema-europa.webex.com/weblink/register/r9ca0c1044ed05282d0fe236251c99a9c\nService Desk for SPOR and XEVMPD – 17 April\, 14:00-16:00 CET – https://ema-europa.webex.com/weblink/register/r1552802c0646096c101b5e62b25dfa5d\nReferentials Management Service (RMS) – 18 April\, 10:00-12:00 CET – https://ema-europa.webex.com/weblink/register/r46516995ff51d5f4383d95f05cac8e38\nOrganisation Management Service (OMS) – 18 April\, 14:00-16:00 – https://ema-europa.webex.com/weblink/register/r834ea26426a57529292e0dcffc96cb5a\nSubstance Management Service (SMS) – 19 April\, 10:00-12:00 CET – https://ema-europa.webex.com/weblink/register/ra85e8fd6945484df2ff2df4f3117a19e\nProduct Management Service (XEVMPD) – 19 April\, 14:00-16:00 CET – https://ema-europa.webex.com/weblink/register/r84045da9fedf6fdec5fd69c8d24a2c3a\nSubstance\, product\, organisation and referential (SPOR) application programming interface (API) – SPOR API – 20 April\, 10:00-12:00 CET – https://ema-europa.webex.com/weblink/register/r00e936a4aeb9d8e1ed61fac53c879858\nEMA Account Management – 20 April\, 14:00-16:00 CET – https://ema-europa.webex.com/weblink/register/r393a359debcd8d2cd14a974465c369e8 URL:https://unicom-project.eu/event/ema-webinar-week/ LOCATION:Virtual CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230413T143000 DTEND;TZID=Europe/Berlin:20230413T160000 DTSTAMP:20260501T125155 CREATED:20230324T181527Z LAST-MODIFIED:20230330T160529Z UID:9223-1681396200-1681401600@unicom-project.eu SUMMARY:NCA KNOWLEDGE TRANSFER: BELGIUM IN FOCUS DESCRIPTION:Agenda : \n\n25’ Results of the FAMHP IDMP gap analysis:\n\n1. EMA : deviations (more\, less\, different) versus ISO IDMP documents (of 2012 and 2017\, whichever is more recent)\n2. FAMHP MPM/DTS : differences with the EMA data model\n3. FAMHP approach to narrow the gaps\n\n\n10’ QUESTIONS\n15’ SAM / ePrescription : dataflow from BE NCA (and other datasources) to mandatory BE ePrescription (on SAM)\n10’ QUESTIONS\n what are the gaps in your NCA datamodel + what is your (intended) approach towards narrowing them ? URL:https://unicom-project.eu/event/nca-knowledge-transfer-belgium-in-focus/ LOCATION:Virtual CATEGORIES:External events related to UNICOM ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2020/02/famhp-1.jpg END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230329T133000 DTEND;TZID=Europe/Berlin:20230329T150000 DTSTAMP:20260501T125155 CREATED:20230126T103239Z LAST-MODIFIED:20230324T181638Z UID:9194-1680096600-1680102000@unicom-project.eu SUMMARY:NCA Knowledge Transfer Webinar: Croatia implementation progress DESCRIPTION:REGISTER NOW FOR THIS EVENT URL:https://unicom-project.eu/event/nca-knowledge-transfer-webinar-croatia-implementation-progress-and-demo/ LOCATION:Online Event – URL on Registration CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230310T100000 DTEND;TZID=Europe/Berlin:20230310T120000 DTSTAMP:20260501T125155 CREATED:20230126T101626Z LAST-MODIFIED:20230126T101626Z UID:9192-1678442400-1678449600@unicom-project.eu SUMMARY:Basic Training IDMP & FHIR for NCAs staff DESCRIPTION:UNICOM is happy to announce a new series of IDMP implementation related training and knowledge transfer webinars in 2023. \nConsidering the recent progress with EMA eAF we believe that it is important that all European NCAs acquire without delay a better understanding of the FHIR standard and its relevance in relationship to a wide IDMP implementation and that more people are informed and trained about this with the NCAs. \nFeel thus free to transfer this invitation to any person in your Agency who could possibly be impacted. \nYou need to REGISTER to have access to the webinar URL:https://unicom-project.eu/event/basic-training-idmp-fhir-for-ncas-staff/ LOCATION:Online Event – URL on Registration CATEGORIES:External events related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20230124 DTEND;VALUE=DATE:20230125 DTSTAMP:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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:20260501T125155 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 END:VCALENDAR