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BEGIN:VEVENT
DTSTART;TZID=Europe/Berlin:20220726T110000
DTEND;TZID=Europe/Berlin:20220726T120000
DTSTAMP:20220719T140135Z
CREATED:20220719T133217Z
LAST-MODIFIED:20220719T140135Z
UID:8980-1658833200-1658836800@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:20220626
DTEND;VALUE=DATE:20220701
DTSTAMP:20220531T130722Z
CREATED:20220531T125105Z
LAST-MODIFIED:20220531T130722Z
UID:8866-1656201600-1656633599@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:20220621T110000
DTEND;TZID=Europe/Berlin:20220621T110000
DTSTAMP:20220531T130637Z
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;VALUE=DATE:20220527
DTEND;VALUE=DATE:20220531
DTSTAMP:20220307T104120Z
CREATED:20220307T103436Z
LAST-MODIFIED:20220307T104120Z
UID:8762-1653609600-1653955199@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:20220516T100000
DTEND;TZID=Europe/Berlin:20220516T120000
DTSTAMP:20220510T101746Z
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:20220503T130000
DTEND;TZID=Europe/Berlin:20220503T140000
DTSTAMP:20220429T064424Z
CREATED:20220429T064424Z
LAST-MODIFIED:20220429T064424Z
UID:8842-1651582800-1651586400@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:20220422T150000
DTEND;TZID=Europe/Berlin:20220422T163000
DTSTAMP:20220414T161717Z
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;VALUE=DATE:20220406
DTEND;VALUE=DATE:20220407
DTSTAMP:20220330T084829Z
CREATED:20220330T084829Z
LAST-MODIFIED:20220330T084829Z
UID:8795-1649203200-1649289599@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:20220404T150000
DTEND;TZID=Europe/Berlin:20220404T170000
DTSTAMP:20220323T171054Z
CREATED:20220323T171054Z
LAST-MODIFIED:20220323T171054Z
UID:8772-1649084400-1649091600@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;TZID=Europe/Berlin:20220330T110000
DTEND;TZID=Europe/Berlin:20220330T130000
DTSTAMP:20220314T155238Z
CREATED:20220208T151719Z
LAST-MODIFIED:20220314T155238Z
UID:8727-1648638000-1648645200@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;VALUE=DATE:20220329
DTEND;VALUE=DATE:20220401
DTSTAMP:20220307T103105Z
CREATED:20220307T102956Z
LAST-MODIFIED:20220307T103105Z
UID:8760-1648512000-1648771199@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:20220318T140000
DTEND;TZID=Europe/Berlin:20220318T160000
DTSTAMP:20220307T102154Z
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: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
END:VCALENDAR