BEGIN:VCALENDAR VERSION:2.0 PRODID:-//UNICOM - ECPv6.3.5//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: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 END:VTIMEZONE BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220114T150000 DTEND;TZID=Europe/Berlin:20220114T163000 DTSTAMP:20240328T110224 CREATED:20220105T164214Z LAST-MODIFIED:20220105T164214Z UID:10000114-1642172400-1642177800@unicom-project.eu SUMMARY:UNICOM Community of Expertise: Vaccine challenges - cleansing\, confidentiality\, and vaccine naming DESCRIPTION: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 an appropriate way. From an industry perspective\, we will address the challenges to conform to these and other guidelines throughout the development process and maintain confidentiality at the same time. \n  \nDate:                 Friday 14th January 2022 \nTime:                 3:00 – 4:30 pm CEST \n  \nPresenters:   \nOlof Lagerlund (UNICOM WP 1\, WHO-UMC)\nAnnet Rozema (UNICOM WP 2\, CBG-MEB)\nJean-Gonzague Fontaine (GSK Vaccines) \nPanelist:   \nRafaella Balocco (WHO)\nMalin Fladvad (UNICOM WP 1\, WHO-UMC) \n \nModerators:   \nChristian Hay (UNICOM WP 1\, GS1 and ISO TC 215/WG6)\nRobert Stegwee (UNICOM WP 1\, CEN TC 251) \n  \nYou can register with the following link: https://us02web.zoom.us/webinar/register/WN_MzHhBDRPRSOWftnAd-J02g URL:https://unicom-project.eu/event/unicom-community-of-expertise-vaccine-challenges-cleansing-confidentiality-and-vaccine-naming/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220118T103000 DTEND;TZID=Europe/Berlin:20220118T120000 DTSTAMP:20240328T110224 CREATED:20211215T091255Z LAST-MODIFIED:20211215T093407Z UID:10000187-1642501800-1642507200@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:20220125T103000 DTEND;TZID=Europe/Berlin:20220125T120000 DTSTAMP:20240328T110224 CREATED:20211215T092442Z LAST-MODIFIED:20211215T092619Z UID:10000113-1643106600-1643112000@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:20220204T150000 DTEND;TZID=Europe/Berlin:20220204T163000 DTSTAMP:20240328T110224 CREATED:20220113T091635Z LAST-MODIFIED:20220120T120822Z UID:10000115-1643986800-1643992200@unicom-project.eu SUMMARY:Community of Expertise: IDMP in clinical applications DESCRIPTION:All infos here URL:https://unicom-project.eu/event/community-of-expertise-idmp-in-clinical-applications/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220216T160000 DTEND;TZID=Europe/Berlin:20220216T173000 DTSTAMP:20240328T110224 CREATED:20220202T094134Z LAST-MODIFIED:20220202T094134Z UID:10000117-1645027200-1645032600@unicom-project.eu SUMMARY:National Competence Centers IDMP Knowledge Transfer Workshop: Portugal in focus DESCRIPTION:Workshop only upon invitation.\nIf you have not received an invitation altjough you work with or for an NCA and would like to take par: send a mail to unicom@ehtel.eu URL:https://unicom-project.eu/event/national-competence-centers-idmp-knowledge-transfer-workshop-portugal-in-focus/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220225T150000 DTEND;TZID=Europe/Berlin:20220225T163000 DTSTAMP:20240328T110224 CREATED:20220113T091757Z LAST-MODIFIED:20220210T175757Z UID:10000116-1645801200-1645806600@unicom-project.eu SUMMARY:Community of Expertise: Guidance for Medicinal Product Dictionaries DESCRIPTION: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/ URL:https://unicom-project.eu/event/community-of-expertise-guidance-for-medicinal-product-dictionaries/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220310T100000 DTEND;TZID=Europe/Berlin:20220310T160000 DTSTAMP:20240328T110224 CREATED:20220307T100758Z LAST-MODIFIED:20220307T100758Z UID:10000119-1646906400-1646928000@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:20220318T140000 DTEND;TZID=Europe/Berlin:20220318T160000 DTSTAMP:20240328T110224 CREATED:20220307T101107Z LAST-MODIFIED:20220307T102154Z UID:10000120-1647612000-1647619200@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;VALUE=DATE:20220329 DTEND;VALUE=DATE:20220401 DTSTAMP:20240328T110224 CREATED:20220307T102956Z LAST-MODIFIED:20220307T103105Z UID:10000121-1648512000-1648771199@unicom-project.eu SUMMARY:DIA EUROPE 2022 29-31 MARCH 2022 BRUSSELS & VIRTUAL DESCRIPTION:UNICOM will be present in the DIA event in the following sessions: \nWednesday\, March 30th\, 13:15 – 14:15\, Hall 100:  link to the session \nThursday\, March 31st\, 09:00 – 10:15\, Hall 100: link to the session \n  URL:https://unicom-project.eu/event/dia-europe-2022-29-31-march-2022-brussels-virtual/ CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220330T110000 DTEND;TZID=Europe/Berlin:20220330T130000 DTSTAMP:20240328T110224 CREATED:20220208T151719Z LAST-MODIFIED:20220314T155238Z UID:10000118-1648638000-1648645200@unicom-project.eu SUMMARY:National Competence Authorities: knowledge transfer on FIHR implementation. DESCRIPTION:Worshop upon invitation only.\nIf you wish to attend\, please send a request to unicom@ehtel.eu \nThe workshop objectives are the following ones:\n– Participants will be able to understand and read FHIR messages describing medicinal products; We will be using draft FHIR-messages provided by EMA/DADI\n– Seceral National Competent Authorities will also prepare examples which will be shared and discussed during the workshop\n– Open questions will be collected and answered or used as material for a follow-up workshop URL:https://unicom-project.eu/event/national-competence-authorities-knowledge-transfer-on-fihr-implementation/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220404T150000 DTEND;TZID=Europe/Berlin:20220404T170000 DTSTAMP:20240328T110224 CREATED:20220323T171054Z LAST-MODIFIED:20220323T171054Z UID:10000188-1649084400-1649091600@unicom-project.eu SUMMARY:Third UNICOM Trans-Atlantic meeting DESCRIPTION: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. \n  \n\nWelcome\, introduction to CTADHL and UNICOM (Vada Perkins\, Frits Stulp and Christian Hay)\nMain & Open discussion\n\nIntroduction:\n\nUS (Elaine Johanson\, Director\, Health Informatics Staff\, FDA)\nEurope (TBC\, EMA)\nWHO-UMC (Dr Herve Le Louët\, Executive Director UMC (Shanthi Pal\, Medicines Safety\, Safety & Vigilance\, WHO))\n\n\nUS IDMP Activities and International IDMP Engagement: \n\nUS FDA and Global IDMP Activities (Ron Fitzmartin & Ta-Jen Chen\, FDA) \nEMA FDA Collaboration Framework (Panagiotis Telonis\, EMA)\nOverview of the Global IDMP WG Pilots (Malin Fladvad\, WHO-UMC) \n\n\nInternational IDMP Initiatives: \n\nIntroduction ISO Systematic Review (Christian Hay\, Executive board member CTADHL\, Sr Consultant Healthcare GS1)\nISO IDMP Logical Model & Ontologies (Sheila Elz\, Master Data Manager Bayer Pharmaceutical)\nISO IDMP Activity update (Vada Perkins\, President CTADHL\, Executive Director Bayer Pharmaceuticals)\n\n\nNCA Perspective UNICOM (TBC\, BfArM)\nOpen discussion\n\n\nClosing remarks and final wrap up (TBC\, FDA)\n\n  URL:https://unicom-project.eu/event/third-unicom-trans-atlantic-meeting/ END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20220406 DTEND;VALUE=DATE:20220407 DTSTAMP:20240328T110224 CREATED:20220330T084829Z LAST-MODIFIED:20220330T084829Z UID:10000189-1649203200-1649289599@unicom-project.eu SUMMARY:Global PharmaceuticaL Regulatory Affairs Summit -Berlin DESCRIPTION:IDMP implementation will be the central topic on April 6 but many other sessions will also have IDMP in the background. \nUNICOM will be represented in two sessions at 10.45 and 15.45 on April 6. \nAll infos and agenda: \n  URL:https://unicom-project.eu/event/global-pharmaceutical-regulatory-affairs-summit-berlin/ CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220422T150000 DTEND;TZID=Europe/Berlin:20220422T163000 DTSTAMP:20240328T110224 CREATED:20220405T071631Z LAST-MODIFIED:20220414T161717Z UID:10000190-1650639600-1650645000@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:20220503T130000 DTEND;TZID=Europe/Berlin:20220503T140000 DTSTAMP:20240328T110224 CREATED:20220429T064424Z LAST-MODIFIED:20220429T064424Z UID:10000191-1651582800-1651586400@unicom-project.eu SUMMARY:ePi HL7 Vulcan accelerator with UNICOM and GravitateHealth DESCRIPTION: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. \nMore info: https://unicom-project.eu/join-the-unicom-and-gravitatehealth-for-the-next-epi-hl7-vulcan-accelerator-on-may-3-13-14-cest/ URL:https://unicom-project.eu/event/epi-hl7-vulcan-accelerator-with-unicom-and-gravitatehealth/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220516T100000 DTEND;TZID=Europe/Berlin:20220516T120000 DTSTAMP:20240328T110224 CREATED:20220510T101227Z LAST-MODIFIED:20220510T101746Z UID:10000192-1652695200-1652702400@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;VALUE=DATE:20220527 DTEND;VALUE=DATE:20220531 DTSTAMP:20240328T110224 CREATED:20220307T103436Z LAST-MODIFIED:20220307T104120Z UID:10000122-1653609600-1653955199@unicom-project.eu SUMMARY:MIE 2022 in Nice: “Challenges of trustable AI and added-value on health” DESCRIPTION:An UNICOM abstact has been accepted. \nUNICOM is thus proud that it will be part of the official programme with a full oral presentation. \nLin to the event: https://mie2022.org/ URL:https://unicom-project.eu/event/mie-2022-in-nice-challenges-of-trustable-ai-and-added-value-on-health/ CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220621T110000 DTEND;TZID=Europe/Berlin:20220621T110000 DTSTAMP:20240328T110224 CREATED:20220531T125658Z LAST-MODIFIED:20220531T130637Z UID:10000195-1655809200-1655809200@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;VALUE=DATE:20220626 DTEND;VALUE=DATE:20220701 DTSTAMP:20240328T110224 CREATED:20220531T125105Z LAST-MODIFIED:20220531T130722Z UID:10000194-1656201600-1656633599@unicom-project.eu SUMMARY:Fourteenth International Conference on eHealth\, Telemedicine\, and Social Medicine: eTELEMED 2022 DESCRIPTION:The Croatian Medicinal products and medical devices Agency (HALMED) will be presenting its roadmap to IDMP implemenation at this event. \nSee: https://www.iaria.org/conferences2022/eTELEMED22.html URL:https://unicom-project.eu/event/fourteenth-international-conference-on-ehealth-telemedicine-and-social-medicine-etelemed-2022/ CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220726T110000 DTEND;TZID=Europe/Berlin:20220726T120000 DTSTAMP:20240328T110224 CREATED:20220719T133217Z LAST-MODIFIED:20220719T140135Z UID:10000199-1658833200-1658836800@unicom-project.eu SUMMARY:1st eAF (DADI) EMA training and Q&A webinar DESCRIPTION:The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration.\nThe guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems\, such as Management Services for Substances\, Products\, Organisation and Referentials (SPOR). \nFor any issues or technical support with EMA’s IT systems\, please raise a ticket with the EMA Service Desk portal. \nInvitation to register to the DADI eAF training and Q&A webinars \nThe Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms\, making the future form-filling and submission-handling process more efficient.\nThe variations form for Human medicinal products will be the first form to be released by DADI in October 2022. To effectively support stakeholders ahead of the go-live date\, EMA is pleased to announce two new public eAF training and Q&A webinars. \n\n1st eAF training and Q&A webinar: 26 July 2022\, 11:00-12:30 Central European Time (CET) – Registration link\n2nd eAF training and Q&A webinar: 2 September 2022\, 11:00-12:30 Central European Time (CET) – Registration link\n\nThese events are training webinars for industry and national competent authorities’ stakeholders wishing to learn more about access management aspects related to the new eAF dedicated portal and the procedure to fill in a web-based eAF at go-live.\nDuring the sessions\, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal\, how to fill in the web-based eAF\, select products and export the forms.\nKindly note recordings from both training sessions will be made available after each event.\nPlease share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu. \n07-07-2022 URL:https://unicom-project.eu/event/1st-eaf-dadi-ema-training-and-qa-webinar/ END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20220824 DTEND;VALUE=DATE:20220829 DTSTAMP:20240328T110224 CREATED:20220531T130412Z LAST-MODIFIED:20220830T165643Z UID:10000196-1661299200-1661731199@unicom-project.eu SUMMARY:ICPE 2022: 38th International Conference for PharmacoEpidemiology DESCRIPTION:Advancing Pharmacoepidemiology and Real-World Evidence for the Global Community \nUNICOM WP8 leader Robert Vanderstichele will be presnting a poster on the the theme: \nWill the implementation of  ISO/CEN Standards for global Identification of Medicinal Products (IDMP) make any difference for pharmaco-epidemiology ? \nVander Stichele RH\, Sturkenboom MCJM\, Duran C\, Nicolas L\, Kalra D\, Fladvad M. URL:https://unicom-project.eu/event/icpe-2022-38th-international-conference-for-pharmacoepidemiology/ CATEGORIES:External events not directly related to UNICOM ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2022/05/PosterUNICOM_ICPE_2022_Copenhagen_RVS-1.png END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220826T150000 DTEND;TZID=Europe/Berlin:20220826T163000 DTSTAMP:20240328T110224 CREATED:20220510T101657Z LAST-MODIFIED:20220621T085516Z UID:10000193-1661526000-1661531400@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:20220902T100000 DTEND;TZID=Europe/Berlin:20220902T233000 DTSTAMP:20240328T110224 CREATED:20220719T133533Z LAST-MODIFIED:20220719T133533Z UID:10000200-1662112800-1662161400@unicom-project.eu SUMMARY:2nd eAF (DADI) EMA training and Q&A webinar DESCRIPTION:The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration.\nThe guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems\, such as Management Services for Substances\, Products\, Organisation and Referentials (SPOR). \nFor any issues or technical support with EMA’s IT systems\, please raise a ticket with the EMA Service Desk portal.\n \nInvitation to register to the DADI eAF training and Q&A webinars \nThe Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms\, making the future form-filling and submission-handling process more efficient.\nThe variations form for Human medicinal products will be the first form to be released by DADI in October 2022. To effectively support stakeholders ahead of the go-live date\, EMA is pleased to announce two new public eAF training and Q&A webinars. \n\n2nd eAF training and Q&A webinar: 2 September 2022\, 11:00-12:30 Central European Time (CET) – Registration link\n\nThese events are training webinars for industry and national competent authorities’ stakeholders wishing to learn more about access management aspects related to the new eAF dedicated portal and the procedure to fill in a web-based eAF at go-live.\nDuring the sessions\, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal\, how to fill in the web-based eAF\, select products and export the forms.\nKindly note recordings from both training sessions will be made available after each event.\nPlease share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu. \n07-07-2022 URL:https://unicom-project.eu/event/2nd-eaf-dadi-ema-training-and-qa-webinar/ END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20220914T090000 DTEND;TZID=Europe/Berlin:20220914T150000 DTSTAMP:20240328T110224 CREATED:20220705T155235Z LAST-MODIFIED:20220705T161132Z UID:10000198-1663146000-1663167600@unicom-project.eu SUMMARY:UNICOM Day at the IHE Europe Connectathon DESCRIPTION:The purpose is to familiarize the UNICOM partners and impacted stakeholders with the well-established and robust IHE testing and certification process\, including the tooling available to support these processes.\nThe session will have a special focus on the interactions between Regulation and Authorization authorities – industry (representing Development and Production) and medicinal product dictionary providers (representing Dissemination and Information). \nIHE Pharmacy is already a well-established domain for the latter two stages in the IDMP landscape: testing for Prescription and Dispensation\, as well as for Utilization and Outcome Assessment has been in place for many years. Numerous vendors have\, for instance\, successfully tested their product’s implementation of the IHE profiles for Pharmacy Prescription (17 vendors) and Pharmacy Dispense (16) and these tests are also used for nationwide implementation in Austria (Medication List operational for several years) and Switzerland\, among others. \nPreliminary programme: URL:https://unicom-project.eu/event/unicom-day-at-the-ihe-europe-connectathon/ LOCATION:montreux\, Switzerland END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20220918 DTEND;VALUE=DATE:20220923 DTSTAMP:20240328T110224 CREATED:20220628T073946Z LAST-MODIFIED:20220830T165246Z UID:10000197-1663459200-1663891199@unicom-project.eu SUMMARY:80TH FIP WORLD CONGRESS OF PHARMACY AND PHARMACEUTICAL SCIENCES in Sevilla (Spain) DESCRIPTION:The International Pharmaceutical Federation (FIP) is the global body representing pharmacy and pharmaceutical sciences. Through our 147 national organisations\, academic institutional members and individual members\, we represent over four million pharmacists and pharmaceutical scientists around the world. \nCongress Theme: Pharmacy united in the recovery of health care \nAt this critical time\, when the challenges presented by the COVID-19 pandemic are still current and on the minds of healthcare professionals\, we must take the opportunity to create more comprehensive plans to better manage health crises that may be on the horizon. Several features of the pandemic may serve as useful springboards to develop better plans for future emergencies and accelerate change in our healthcare systems. It is our responsibility to review our shared experiences and search for solutions to advance the well-being of global communities. In creating “the new normal”\, pharmacy\, united together\, can contribute to the recovery of our healthcare systems by building on our developments and innovations during the past two years. \nTwo UNICOM related abstracts have been accepted for this conference. URL:https://unicom-project.eu/event/80th-fip-world-congress-of-pharmacy-and-pharmaceutical-sciences/ LOCATION:SEVILLA\, Spain END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20221104T150000 DTEND;TZID=Europe/Berlin:20221104T163000 DTSTAMP:20240328T110224 CREATED:20221024T141028Z LAST-MODIFIED:20221024T141028Z UID:10000204-1667574000-1667579400@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;VALUE=DATE:20221106 DTEND;VALUE=DATE:20221108 DTSTAMP:20240328T110224 CREATED:20220914T110347Z LAST-MODIFIED:20220914T110902Z UID:10000201-1667692800-1667865599@unicom-project.eu SUMMARY:Global Connections for Sustainable Telehealth - California -USA DESCRIPTION:Organized by ISfTeH \nA one-of-a-kind meeting to discuss successful business models\, opportunities in emerging markets\, the challenges\, and solutions for cybersecurity and international regulatory navigation.* \nThe International Society for Telemedicine and eHealth (ISfTeH) is a federation of 45 national professional associations in the Telemedicine and eHealth space globally. The society also has institutional\, corporate\, and individual members in another 35 plus countries worldwide. As a global partner in digital health with a footprint in over 110 countries and territories\, the mission of the ISfTeH since its inception 25 years ago has been to “facilitate the international dissemination of knowledge and experience in Telemedicine and eHealth and provide access to recognized experts in the field worldwide.” URL:https://unicom-project.eu/event/global-connections-for-sustainable-telehealth-california-usa/ CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20221107 DTEND;VALUE=DATE:20221111 DTSTAMP:20240328T110224 CREATED:20221010T144410Z LAST-MODIFIED:20221010T152633Z UID:10000202-1667779200-1668124799@unicom-project.eu SUMMARY:pHealth conference DESCRIPTION:The 2022 edition of pHealth will emphasize the interrelated aspects of pHealth\, i.e. advanced digital health ecosystems. In that context\, mobile technologies\, micro-nano-bio smart systems\, bio-data management and analytics\, machine learning\, artificial intelligence and robotics for personalized health\, the Health Internet of Things (HIoT)\, systems medicine\, public health and virtual care. \nUNICOM WP1 intends to be present with a poster. URL:https://unicom-project.eu/event/phealth-conference/ LOCATION:Oslo\, Norway CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20221207T150000 DTEND;TZID=Europe/Berlin:20221207T170000 DTSTAMP:20240328T110224 CREATED:20221213T093949Z LAST-MODIFIED:20221213T094245Z UID:10000205-1670425200-1670432400@unicom-project.eu SUMMARY:4th Transtlantic Virtual meeting - GIDWG Working Group DESCRIPTION:The UNICOM trans-Atlantic meetings are 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. URL:https://unicom-project.eu/event/4th-transtlantic-virtual-meeting-gwgig/ ATTACH;FMTTYPE=image/png:https://unicom-project.eu/wp-content/uploads/2022/12/TRANSTLANTIC-schema.png END:VEVENT BEGIN:VEVENT DTSTART;VALUE=DATE:20221212 DTEND;VALUE=DATE:20221213 DTSTAMP:20240328T110224 CREATED:20221010T152950Z LAST-MODIFIED:20221010T153014Z UID:10000203-1670803200-1670889599@unicom-project.eu SUMMARY:Health care policy conference (Greece) DESCRIPTION: URL:https://unicom-project.eu/event/health-care-policy-conference-greece/ LOCATION:Athens\, ROYAL OLYMPIC\, Greece CATEGORIES:External events not directly related to UNICOM END:VEVENT BEGIN:VEVENT DTSTART;TZID=Europe/Berlin:20230110T130000 DTEND;TZID=Europe/Berlin:20230110T140000 DTSTAMP:20240328T110224 CREATED:20230110T104906Z LAST-MODIFIED:20230110T104906Z UID:10000208-1673355600-1673359200@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 END:VCALENDAR