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BEGIN:DAYLIGHT
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BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20220310T100000
DTEND;TZID=Europe/Berlin:20220310T160000
DTSTAMP:20220307T100758Z
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:20220225T150000
DTEND;TZID=Europe/Berlin:20220225T163000
DTSTAMP:20220210T175757Z
CREATED:20220113T091757Z
LAST-MODIFIED:20220210T175757Z
UID:8336-1645801200-1645806600@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:20220216T160000
DTEND;TZID=Europe/Berlin:20220216T173000
DTSTAMP:20220202T094134Z
CREATED:20220202T094134Z
LAST-MODIFIED:20220202T094134Z
UID:8725-1645027200-1645032600@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:20220204T150000
DTEND;TZID=Europe/Berlin:20220204T163000
DTSTAMP:20220120T120822Z
CREATED:20220113T091635Z
LAST-MODIFIED:20220120T120822Z
UID:8334-1643986800-1643992200@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:20220125T103000
DTEND;TZID=Europe/Berlin:20220125T120000
DTSTAMP:20211215T092619Z
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:20211215T093407Z
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:20220114T150000
DTEND;TZID=Europe/Berlin:20220114T163000
DTSTAMP:20220105T164214Z
CREATED:20220105T164214Z
LAST-MODIFIED:20220105T164214Z
UID:8328-1642172400-1642177800@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:20211213T090000
DTEND;TZID=Europe/Berlin:20211213T120000
DTSTAMP:20211019T095058Z
CREATED:20211019T095058Z
LAST-MODIFIED:20211019T095058Z
UID:8148-1639386000-1639396800@unicom-project.eu
SUMMARY:Training workshop on FHIR for NCAs
DESCRIPTION:This event is open to ALL National Competent Authoritities; \nIf you have not received an invitation\, send a request to the follwoing email adress: unicom@ehtel.eu \nWP4  kindly invites you to the follow-up training based on the concept presentation we had last year.\nWe will prepare a FHIR example. We will use EMA’s LOSEC example as a basis.
URL:https://unicom-project.eu/event/training-workshop-on-fhir-for-ncas/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211203T150000
DTEND;TZID=Europe/Berlin:20211203T163000
DTSTAMP:20211104T135038Z
CREATED:20211104T135038Z
LAST-MODIFIED:20211104T135038Z
UID:8183-1638543600-1638549000@unicom-project.eu
SUMMARY:Community of Expertise: Using IDMP in Adverse Event reporting and Individual Case Safety Reports (ICSR)
DESCRIPTION:Topic: Using IDMP in Adverse Event reporting and Individual Case Safety Reports (ICSR) \nDate: 3 December between 3 – 4:30 pm CET \nPresenters: \nAnja van Haren\nBarry Hammond (UNICOM WP 1 and MedDRA)\nSarah Vaughn (MHRA) \nPanelists:\nJulie James (UNICOM WP 9 and BlueWaves)\nJane Millar ( UNICOM WP 1 and SNOMED CT)
URL:https://unicom-project.eu/event/community-of-expertise-using-idmp-in-adverse-event-reporting-and-individual-case-safety-reports-icsr/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211126T090000
DTEND;TZID=Europe/Berlin:20211126T160000
DTSTAMP:20211109T172238Z
CREATED:20211109T170806Z
LAST-MODIFIED:20211109T172238Z
UID:8191-1637917200-1637942400@unicom-project.eu
SUMMARY:UNICOM CONSORTIUM MEETING
DESCRIPTION:
URL:https://unicom-project.eu/event/unicom-consortium-meeting-2/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211125T130000
DTEND;TZID=Europe/Berlin:20211125T173000
DTSTAMP:20211109T170640Z
CREATED:20211109T170640Z
LAST-MODIFIED:20211109T170640Z
UID:8187-1637845200-1637861400@unicom-project.eu
SUMMARY:UNICOM CONSORTIUM MEETING
DESCRIPTION:
URL:https://unicom-project.eu/event/unicom-consortium-meeting/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20211116T150000
DTEND;TZID=Europe/Brussels:20211116T173000
DTSTAMP:20211025T163628Z
CREATED:20211025T163628Z
LAST-MODIFIED:20211025T163628Z
UID:8162-1637074800-1637083800@unicom-project.eu
SUMMARY:Second UNICOM Trans-Atlantic Workshop
DESCRIPTION:The UNICOM Trans-Atlantic meeting will be officially coordinated by *CTADHL\, a UNICOM partner formally tasked for trans-Atlantic outreach by UNICOM to include promotion and adoption of ISO IDMP across the medicinal product lifecycle. Although UNICOM is an EU initiative\, it strongly considers collaboration and exchange with North American stakeholders as part of its remit to actively promote a common vision for IDMP and other relevant data standards adoption on an international scale.\n\n \n\nWe have planned the following agenda :\n\n \n\n• Welcome\, introduction to CTADHL and UNICOM (Vada Perkins\, Frits Stulp and Christian Hay)\n\n \n\n• Main & Open discussion\n\n \n\no   WP1 : IDMP related standards and terminologies (TBD & Christan Hay – UNICOM)\n\n \n\no   WP2 : Implement IMDP\, substance management in Europe (Annet Rozema\, EU-SRS project manager\, CBG-MEB)\n\n \n\no   WP3 : Pan-European IDMP compliant application forms (Georg Neuwirther\, Head of IT\, Austrian medicines and medical devices agency)\n\n \n\no   WP4 : IDMP implementation at national drug agencies (TBD)\n\n \n\no   Open discussion\n\n \n\n• Closing remarks and final wrap up (TBD)\n\n \n\nWe very much welcome your participation and RSVP (registration) at the earliest convenience with meeting details provided directly from Zoom once registered.
URL:https://unicom-project.eu/event/second-unicom-trans-atlantic-workshop/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211104T090000
DTEND;TZID=Europe/Berlin:20211104T120000
DTSTAMP:20211019T094419Z
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;VALUE=DATE:20211030
DTEND;VALUE=DATE:20211101
DTSTAMP:20211028T133841Z
CREATED:20211028T133633Z
LAST-MODIFIED:20211028T133841Z
UID:8179-1635552000-1635724799@unicom-project.eu
SUMMARY:International Workshop Health Economics and Pharmacoeconomics (Postdam)
DESCRIPTION:Scenarium in cooperation with Fundisa – African Academy of Medicine Development\, supported by GHA-German Health Alliance as well as other prominent partners are organising the first edition of an international workshop on\nHealth Economics and Pharmacoeconomics: Opportunities for German-African Cooperation\nOctober 30-31\, 2021\nhybrid event \nThe workshop will take place simultaniously at University of Potsdam\, Germany and African Pride Irene Country Lodge\, South Africa. There is a limited attendance on-site but the event can also be followed online.\nTechnology assessment (HTA) plays an increasing role in decision-making in product development\, licencing\, pricing and reimbursement. This international workshop emphasises upcoming trends in HTA in light of health systems strengthening towards universal health coverage. It provides a forum for cooperation between German and African partners and for networking between experts from industry (medicines\, medical devices and diagnostics)\, academia\, funders/payers\, health technology assessment agencies\, government officials\, consumers (patient organisations)\, young scientists and students.\nThe workshop’s panels tackle some of the most relevat issues in the field of health economics and health systems strengthening with a particular focus on the role of HTA:\n• Health technology assessment (HTA) in health systems strengthening\n• Trends and methods in health economics\n• Capacity building: Cross-country collaboration\n• Global collaboration in health economics – an African perspective \nThe participation is free of charge but a registration is mandatory. For further enquiries please contact Anri Jooste (info@fundisa-academy.com)
URL:https://unicom-project.eu/event/international-workshop-health-economics-and-pharmacoeconomics-postdam/
CATEGORIES:External events not directly related to UNICOM
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211029T150000
DTEND;TZID=Europe/Berlin:20211029T163000
DTSTAMP:20211020T150719Z
CREATED:20211018T080221Z
LAST-MODIFIED:20211020T150719Z
UID:8144-1635519600-1635525000@unicom-project.eu
SUMMARY:Last perspectives on substance and strength in IDMP: Join us on the 29th of October!
DESCRIPTION:The world is teaming up to provide clarity on the identification of substances and the representation of strength. This Community of Expertise will present different recent perspectives on these activities\, with speakers reprensenting the views and work of regulatory\, industry and standards stakeholders. \n\n\n\nSpeakers: \n\n\n\n\nIsabel Chicharo\, EMA: Implementing substance cleansing results in SMS \n\n\n\n\n\nPetra Kristic\, Senior Manager Regulatory Compliance & Regulatory Information Management\, Merck Healthcare KGaA: Concentration strength versus Presentation strength \n\n\n\n\n\nJeff Martin\, SMPA: Data Patterns for IDMP-based Medicinal Product Information\n\n\n\n\nPanelists:  \n\n\n\nAnnet Rozema (CBG-MED\, UNICOM WP2)\, \n\n\n\nMalin Fladvad (WHO-UMC\, UNICOM WP1) \n\n\n\nJean Gonzague (Product and Substance (inc. IDMP) Master Data Lead\, GSK vaccine) \n\n\n\n\nRegister: https://us02web.zoom.us/webinar/register/WN_GbbJgcMIT8Wroxg1tWYBaw
URL:https://unicom-project.eu/event/last-perspectives-on-substance-and-strength-in-idmp-join-us-on-the-29th-of-october/
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20211016
DTEND;VALUE=DATE:20211018
DTSTAMP:20210930T090642Z
CREATED:20210806T084250Z
LAST-MODIFIED:20210930T090642Z
UID:8007-1634342400-1634515199@unicom-project.eu
SUMMARY:19th International Conference on Informatics\, Management\, and Technology in Healthcare (ICIMTH 2021)
DESCRIPTION:This year the 19th International Conference on Informatics\, Management\, and Technology in Healthcare (ICIMTH 2021) is announced as an eConference (no physical presence is required) due to the COVID-19 pandemic. The Conference (www.icimth.com) will be held for this year on: 16-17 October\, 2021. The modification of the traditional Conference to a Virtual event is due to force majeure of the COVID-19 pandemic. If the current situation improves to allow partial live presence\, then we will inform the participants\, accordingly. \nOn Sunday 17th of October\, UNICOM will be presenting a tutorial based on IDMP in a capsule  \nCheck the agenda on the ICTMH to know about the precise timing
URL:https://unicom-project.eu/event/19th-international-conference-on-informatics-management-and-technology-in-healthcare-icimth-2021/
CATEGORIES:External events not directly related to UNICOM
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211014T160000
DTEND;TZID=Europe/Berlin:20211014T190000
DTSTAMP:20211012T084403Z
CREATED:20211012T084403Z
LAST-MODIFIED:20211012T084403Z
UID:8127-1634227200-1634238000@unicom-project.eu
SUMMARY:HL7 Europe: Listening Session
DESCRIPTION:Dear members of the UNICOM Consortium. \nYou are cordially invited to the HL7 Europe Listening Session. \nThe purpose of this session is to inform the HL7 International community of specific developments in European countries and Europe as a region. \nShort topical introductions will be provided by the Board Chair of HL7 International and some of HL7 Europe’s key people\, but it is YOUR contribution that we are looking for. \nAgenda\n\nWelcome – Charles Jaffe\, CEO\, HL7 International\nRe-envisioning Overview – Walter Suarez\, HL7 International Board Chair\nHL7 Hospital on FHIR – Henrique Martins\nHL7 in European Health Systems – Christof Gessner\nLeveraging Accelerators in Europe – Catherine Chronaki\nHL7 Europe Technical Coordination Team – Giorgio Cangioli\nOpen Discussion – Robert Stegwee\, Moderator\n\nThis is one in a series of regional listening sessions that HL7 International is organizing. Participation is free of charge\, but we do request you to register for the event.\n\n\n\n\n\n\n\n  \n\n\n\n\n\n\n\nRegister Now\n\n\n\n\n\n\n\n 
URL:https://unicom-project.eu/event/hl7-europe-listening-session/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20211001T150000
DTEND;TZID=Europe/Berlin:20211001T163000
DTSTAMP:20211217T094230Z
CREATED:20210917T071544Z
LAST-MODIFIED:20211217T094230Z
UID:8073-1633100400-1633105800@unicom-project.eu
SUMMARY:Community of expertise: The role of Dose Forms in the generation of a global Pharmaceutical Product Identifier (PhPID)
DESCRIPTION:Defining characteristics for dose forms\, which meet global needs\, is a challenge addressed by EDQM and several stakeholders. \nThis webinar will present the views regarding the “global” aspect of dose form definition: in the regulatory space\, in the clinical space\, in the domain of adverse event monitoring and what efforts EDQM is deploying to meet these requirements\, to be captured in the revision of the relevant ISO standard and the EDQM Standard Terms. \nDate:                  Friday 1st October 2021 \nTime:                  3:00 – 4:30 pm CEST \nPresenters:         Christopher Jarvis (UNICOM WP 1\, EDQM) \n                                Malin Fladvad (UNICOM WP 1\, WHO-UMC) \n                                TJ Chen (US FDA) \n                                Joseph Roumier (I~HD) \n  \nPanelist:            Robert Vander Stichele (UNICOM WP 1\, i~HD) \n                             Ron Fitzmartin (US FDA)) \n  \nModerators:     Christian Hay (UNICOM WP 1\, GS1 and ISO TC 215/WG6) \n                               Robert Stegwee (UNICOM WP 1\, CEN TC 251) \n  \nYou can register with the following link: https://us02web.zoom.us/webinar/register/WN_2mpp6dcXRo-z6CNxg1latA
URL:https://unicom-project.eu/event/community-of-expertise-the-role-of-dose-forms-in-the-generation-of-a-global-pharmaceutical-product-identifier-phpid/
LOCATION:Online Event – URL on Registration
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20210913
DTEND;VALUE=DATE:20210916
DTSTAMP:20210830T144019Z
CREATED:20210830T144019Z
LAST-MODIFIED:20210830T144019Z
UID:8045-1631491200-1631750399@unicom-project.eu
SUMMARY:28th HL7 FHIR Connectathon -virtual 13-15 September 2021
DESCRIPTION:A medicine’s ePI ( Electronic Product Information) is regulated\, scientifically validated information to assist healthcare professionals in prescribing and dispensing\, and informs patients and consumers about their medicine and its safe use. Thus\, trusted access and understanding of up-to-date product information on medicines when and where it is needed is extremely important. In Europe\, the EMA in collaboration with Heads of Medicines Agencies in member states and the European Commission\, has developed key principles through stakeholder consultations to guide the development and use of ePI in the EU. \nThe vision of the Vulcan HL7 accelerator is to connect clinical research and healthcare bringing together stakeholders across the translational and clinical research community in order to bridge existing gaps\, strategically connecting industry collaboratives\, maximize collective resources\, and deliver integrated tools and resources. \nThe HL7® Structured Product Labelling standard (SPL) used by FDA to present medicinal product information is well known.. The European Medicine’s Agency (EMA) has  Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) formats for electronic product information (ePI). \nEarlier this summer\, EMA released the first version of the Draft ePI Application Program Interface (API) specification in HL7® FHIR® that was open for consultation until the end of July. During the month of July 2021\, a series of webinars and hands on workshops helped stakeholders get acquainted with the standard using an experimental FHIR server hosted by EMA. \nThe upcoming HL7® FHIR® connectathon will explore more specific consumer centered use cases that make use of the specification in the context of the larger eHealth ecosystem. These use cases are linked the Gravitate Health project. \nThe Gravitate Health project (www.gravitatehealth.eu)\, under the Innovative Medicines Initiative\, explores how to use the ePI standard in conjunction with the HL7® FHIR® International Patient Summary (IPS) and other services such as those under myHealth@EU or EMA’s own SPOR implementation of ISO IDMP\, to increase access\, understanding\, adherence\, and safe use of medicines. UNICOM provides a major contribution to the prcatical implementation of the ISO-IDMP standard. \n https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-eu-common-standard-electronic-product-information-human-medicines-epi_en.pdf \n https://www.hl7.org/vulcan/ \n  \nIf you are interested in joining the FHIR Connecthon ePI track do not hesitate to contact us. We are looking for app developers\, electronic health record vendors\, business developers\, software engineers interested in developing ideas and solutions! \nHere are some resources to look at: \n\nConnectathon track\n\nhttps://confluence.hl7.org/pages/viewpage.action?pageId=120095544&src=contextnavpagetreemode \n\nVulcan accelerator will have a track on patient leaflets\n\nhttps://www.hl7.org/vulcan/ \nhttps://confluence.hl7.org/display/VA/Vulcan+Accelerator+Home
URL:https://unicom-project.eu/event/28th-hl7-fhir-connectathon-virtual-13-15-september-2021/
LOCATION:Virtual
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20210827T150000
DTEND;TZID=UTC:20210827T163000
DTSTAMP:20210806T084431Z
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=Europe/Helsinki:20210827T150000
DTEND;TZID=Europe/Helsinki:20210827T163000
DTSTAMP:20210713T115742Z
CREATED:20210709T074628Z
LAST-MODIFIED:20210713T115742Z
UID:7595-1630076400-1630081800@unicom-project.eu
SUMMARY:Community of Expertise webinar: Substance identification using INN and ATC – governance\, use\, and relation to IDMP
DESCRIPTION:What is the relation between INN\, ATC and substance identification according to IDMP? For the identification of substances\, IDMP relies on data available in the Global Substance Registration System (GSRS). Its European counterpart EU-SRS is being implemented\, supported by UNICOM WP 2\, where an important data cleansing work is in progress. \nThis webinar will cover the different ways in which substances are identified and classified in the pharmaceutical domain.\nInternational Nonproprietary Names (INN) facilitate the identification of substances such as active pharmaceutical ingredients.\nEach INN is a unique name that is globally recognized and placed and maintained by the World Health Organization in the public domain.\nThe ATC Classification (Anatomical Therapeutic Chemical) provides a hierarchical classification of drugs with therapeutic\, pharmacological\nand chemical groups. The ATC/DDD methodology is the WHO recommended standard for international drug utilization monitoring and\nresearch and is maintained by the WHO Collaborating Centre for Drug Statistics Methodology\, in Oslo. It links to INN at the most \ndetailed level\, whenever possible. Currently\, ATC is also used extensively in prescribing and dispensing systems\, including cross-border\nePrescribing. In the domain of IDMP\, substances are defined and identified according EN ISO 11238; implementation in Europe is progressing\nunder the leadership of EMA. \nWhat is the relation between INN\, ATC and substance identification according to IDMP? For the identification of substances\, IDMP relies on\ndata available in the Global Substance Registration System (GSRS). Its European counterpart EU-SRS is being implemented\, supported by\nUNICOM WP 2\, where an important data cleansing work is in progress. \nThe presentations will focus on the background\, purpose\, and governance of each of these identification and classification systems as well\nas their linkage. The discussion will also address how their use outside the originally defined scope may have consequences and limitations\nfor the correct use of medicinal products across the countries. \nDate: Friday 27 August 2021 \nTime: 3:00 – 4:30 pm CEST \nPresenters:\nDr Rafaella Balocco (WHO\, Geneva )\nChristian Lie Berg (UNICOM WP 1\, WHO-DSM\, Oslo ) \nPanelist:\nAntonio Romeo (WHO)\nRobert Vander Stichele (UNICOM WP 1\, i~HD)\nOlof Lagerlund (UNICOM WP 1\, WHO-UMC) \n​Moderators:\nChristian Hay (UNICOM WP 1\, GS1 and ISO TC 215/WG6)\nRobert Stegwee (UNICOM WP 1\, CEN TC 251) \nYou can register with the following link: https://us02web.zoom.us/webinar/register/WN_Pre8ne2HTguXWjtZzpS3hw
URL:https://unicom-project.eu/event/community-of-expertise-webinar-substance-identification-using-inn-and-atc-governance-use-and-relation-to-idmp/
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20210629T150000
DTEND;TZID=UTC:20210629T163000
DTSTAMP:20210625T111353Z
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:20210609T091533Z
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:20210615T090000
DTEND;TZID=UTC:20210617T230000
DTSTAMP:20210603T042800Z
CREATED:20210603T042755Z
LAST-MODIFIED:20210603T042800Z
UID:7389-1623747600-1623970800@unicom-project.eu
SUMMARY:IHE Connectathon Experience Week
DESCRIPTION:Register here: \nhttps://connectathon.ihe-europe.net/connectathon/ihe-europe-experience
URL:https://unicom-project.eu/event/ihe-connectathon-experience-week/
CATEGORIES:Other
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20210608T150000
DTEND;TZID=UTC:20210608T170000
DTSTAMP:20210603T082958Z
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:20210603T083702Z
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:20210601T160000
DTEND;TZID=UTC:20210601T170000
DTSTAMP:20210519T151345Z
CREATED:20210519T151345Z
LAST-MODIFIED:20210519T151345Z
UID:7327-1622563200-1622566800@unicom-project.eu
SUMMARY:Vulcan Adverse Events Roundtable
DESCRIPTION:Initial roundtable discussion of groups involved in Adverse Events hosted by the FHIR Clinical Research Accelerator “Vulcan”. \nRepresentatives from UNICOM T8.4 will “sit at the (round)table”.
URL:https://unicom-project.eu/event/vulcan-adverse-events-roundtable/
CATEGORIES:Other
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20210528T150000
DTEND;TZID=UTC:20210528T163000
DTSTAMP:20210519T094859Z
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;VALUE=DATE:20210522
DTEND;VALUE=DATE:20210530
DTSTAMP:20210108T162337Z
CREATED:20210108T162337Z
LAST-MODIFIED:20210108T162337Z
UID:6540-1621641600-1622332799@unicom-project.eu
SUMMARY:HL7 WGM
DESCRIPTION:
URL:https://unicom-project.eu/event/hl7-wgm/
LOCATION:New Orleans\, LA\, United States
CATEGORIES:External events not directly related to UNICOM
ATTACH;FMTTYPE=image/jpeg:https://unicom-project.eu/wp-content/uploads/2020/02/hl7.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20210504T160000
DTEND;TZID=UTC:20210504T170000
DTSTAMP:20210603T043122Z
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
END:VCALENDAR