| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | |
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1 | Open Data Institute (ODI) project: secondary use of health data in Europe | |||||||||||||||||||||||||
2 | Data correct at 1 July 2022 | |||||||||||||||||||||||||
3 | ||||||||||||||||||||||||||
4 | ||||||||||||||||||||||||||
5 | Indicator | ODI manifesto area | Activity title | Activity description | Activity date | Activity type | Link | |||||||||||||||||||
6 | ODI manifesto area: Infrastructure | |||||||||||||||||||||||||
7 | Burden of Disease registries | Infrastructure | EU4 Health financing | Call for proposals to monitor and strengthen the implementation of innovative approaches to prostate, lung and gastric cancer screening at EU level | 01/10/2022 - 31/12/2022 | Call for proposals | https://ec.europa.eu/assets/sante/health/funding/wp2022_en.pdf (page 23) | |||||||||||||||||||
8 | Infrastructure | One Health pathogen surveillance system | Call for proposals to support Member States’ authorities to contribute to the setting and scaling up of this animal and environmental surveillance system, including the systematic ongoing collection of data by European Food Safety Authority (EFSA). | 01/04/2022 - 30/06/2022 | Call for proposals | https://ec.europa.eu/assets/sante/health/funding/wp2022_en.pdf (page 39) | ||||||||||||||||||||
9 | Infrastructure | European Reference Network on Rare Bone Diseases 5th Anniversary online conference | EuRR-Bone annual meeting and ERN BOND meeting will have a joint meeting giving the opportunity to discuss together about the common activities already completed and to be implemented in the future. | 08/02/22 - 09/02/22 | Conference | https://ernbond.eu/2022/02/04/european-reference-network-on-rare-bone-diseases-5th-anniversary-online-conference/ | ||||||||||||||||||||
10 | Infrastructure | European Registries for Rare Endocrine Conditions (EuRRECa) 4th Annual Project Group Meeting | EuRRECa held its 4th annual meeting online on Monday 14th February 2022. This meeting provided an update on the activities of the EuRRECa project which was launched in 2018. | 14/02/2022 | Meeting | https://eurreca.net/eurreca-annual-project-group-meeting-2022/ | ||||||||||||||||||||
11 | Infrastructure | Development of an ERN CRANIO registry | ERN CRANIO is developing a registry focused on the outcome of treatment using standardised diagnosis specific outcome sets (starting with craniosynostosis and cleft lip/palate) - including patient reported outcome measures and outcomes on patients’ quality of life. | Unscheduled | Publication | https://ern-cranio.eu/for-clinicians/ern-cranio-registry-and-outcome-measurement/ | ||||||||||||||||||||
12 | Infrastructure | EpiCARE Registry Project | ERN EpiCARE registry will allow understanding of the epidemiology of rare and complex epilepsies, provide guidelines for early recognition and reduce inequality in diagnosis. It will also localise patients and facilitate their participation in therapy trials, allowing their access to optimised care. Finally, this will lead to better and more equality in patient care across Europe. | 01/05/2022 - 30/04/2024 | Publication | https://epi-care.eu/epicares-activities/registry-project/ | ||||||||||||||||||||
13 | Infrastructure | European Reference Network Neurological Diseases Registry | The ERN-RND Registry is currently being developed. The registry will undergo a phase of intense iterative pilot testing. We plan to roll-out the registry in 2022. | 01/01/2022 - 31/12/2022 | Publication | https://www.ern-rnd.eu/ern-rnd-registry/ | ||||||||||||||||||||
14 | Infrastructure | Third ERKReg (European Rare Kidney Disease Registry) User Day | This meeting will be held for those local team members who are in charge of entering patients into the ERKReg database. Information will be presented on new registry features and to encourage the exchange of user experience. | 08/06/2022 | Conference | https://www.erknet.org/patients-registry/registry-mission | ||||||||||||||||||||
15 | Infrastructure | 3rd EU Health Programme Call for project proposals under the Annual Work Programme 2019 | This is a call for grants in the area of health under the Third Programme for the Union's action in the field of health. Grant agreements will be concluded in relation to rare disease registries for the European Reference Networks | 14/05/2019 | Call for proposals | https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/pj-01-2019 | ||||||||||||||||||||
16 | Infrastructure | Proposal for the European Reference Network for rare inherited and congenital digestive anomalies | ERNICA representatives put together a proposal for submission | 1/10/2019 - 30/10/2019 | Publication | https://ern-ernica.eu/media/2768/extended-issue-ernica-newsletter-april-2020.pdf | ||||||||||||||||||||
17 | Infrastructure | 2020 First Annual European Reference Network for rare inherited and congenital digestive anomalies (ERNICA) Meeting | Online meeting to kickstart discussions on implementation of the ERNICA registry, a three year project with 200 000 EUR of funding | 23/04/2020 - 24/04/2020 | Meeting | https://ern-ernica.eu/media/2768/extended-issue-ernica-newsletter-april-2020.pdf | ||||||||||||||||||||
18 | Infrastructure | 2021 Annual European Reference Network for rare inherited and congenital digestive anomalies (ERNICA) Meeting - Lille | Two-day meeting on the continuation and expansion of ERNICA and current and future ERNICA activities. Also, the chair of the ERNICA Scientific Committee presented the intention to develop an overall ERNICA research strategy 2022-2027 | 29/09/2021 - 01/10/2021 | Meeting | https://www.fimatho.fr/en/news/337-a-look-back-at-the-ernica-2021-meeting | ||||||||||||||||||||
19 | Infrastructure | European Cystic Fibrosis Society Patient Registry (ECFSPR) Annual Report 2018 | Report aims to provide a reliable and comprehensive picture of clinical outcomes in CF across Europe that will help to enhance quality of CF care in Europe, and to increase the number of countries and centres that contribute data to the ECFSPR to achieve complete European-wide coverage | 01/01/2019 - 31/03/2019 | Publication | https://www.ecfs.eu/sites/default/files/general-content-files/working-groups/ecfs-patient-registry/ECFSPR_Report_2018_v1.4.pdf | ||||||||||||||||||||
20 | Infrastructure | European Cystic Fibrosis Society Patient Registry (ECFSPR) Annual Report 2019 | Report aims to provide a reliable and comprehensive picture of clinical outcomes in CF across Europe that will help to enhance quality of CF care in Europe, and to increase the number of countries and centres that contribute data to the ECFSPR to achieve complete European-wide coverage | 01/01/2020 - 31/03/2020 | Publication | https://www.ecfs.eu/sites/default/files/general-content-files/working-groups/ecfs-patient-registry/ECFSPR_Report_2019_v1_16Feb2022.pdf | ||||||||||||||||||||
21 | Infrastructure | The Rare Disease (RD) Registry Data Warehouse | The main objective of the European Platform on Rare Disease Registration (EU RD Platform) is to cope with the enormous fragmentation of rare disease (RD) patients data contained in hundreds of registries across Europe. A registry with three elements, the ERN-Lung Registry, the ERN-Lung Population Registry, and Disease Specific Registries | 01/04/2018 - 30/11/2021 | Launch | https://webgate.ec.europa.eu/chafea_pdb/health/projects/777295/summary | ||||||||||||||||||||
22 | Infrastructure | The European Reference Network ERN-Skin Registry | ERN-Skin is going to build a central ERN-Skin registry that will receive patient information from different European sources and will push that information into the European Rare Disease Registry Infrastructure (ERDRI). | 01/05/2020 - 30/04/2023 | Launch | https://webgate.ec.europa.eu/chafea_pdb/health/projects/947690/summary | ||||||||||||||||||||
23 | Infrastructure | European Reference on Rare Adult Solid Cancer (ERN-EURACAN) registry | Health Programme funded project aimed to set-up a clinical registry for EURACAN. The project will run for 36 months. | 01/04/2020 | Launch | https://euracan.eu/wp-content/uploads/2021/02/EURACAN-Registry-leaflet.pdf | ||||||||||||||||||||
24 | Infrastructure | TRacKING Registry | Registry aiming at collecting data from adult cancer patients harboring actionable fusions, to improve their management. The registry was approved by the French Ethics Committee in December 2020. | 01/12/2020 - 31/12/2020 | Launch | https://euracan.eu/research/tracking/ https://euracan.eu/wp-content/uploads/2021/03/tracking-newsletter-feb21.pdf | ||||||||||||||||||||
25 | Infrastructure | European Registries for Rare Endocrine Conditions (EuRRECa) Project Group Meeting | Project Group Meeting for all members of the EuRRECa Expert Working Groups, Independent Advisory Board and representatives working to establish a data registry | 09/03/2020 | Meeting | https://eurreca.net/2nd-eurreca-project-group-meeting/ | ||||||||||||||||||||
26 | Infrastructure | European Committee Joint Research Centre meeting of European Reference Network registries | Oversight group to establish co-definition of the legal framework for the establishment of the European Reference Networks and their data registries | 01/05/2019 | Meeting | https://www.ema.europa.eu/en/documents/presentation/presentation-registries-european-reference-networks-erns-helene-le-borgne_en.pdf | ||||||||||||||||||||
27 | Infrastructure | European Registries for Rare Endocrine Conditions (EuRRECa) Annual Meeting | Project Group Meeting for all members of the EuRRECa Workpackage and Expert Working Groups, Independent Advisory Board and representatives of ESE, ESPE, Endo-ERN, DGSANTE and JRC, Held in Budapest | 11/03/2019 | Meeting | https://eurreca.net/eurreca-project-group-meeting/ | ||||||||||||||||||||
28 | Infrastructure | European Reference Network registries: Official launch | Oversight group to progress a European network of data registries for rare diseases | 17/04/2018 | Launch | https://eurreca.net/past-events/ | ||||||||||||||||||||
29 | Infrastructure | European Registries for Rare Endocrine Conditions (EuRRECa) Project Group Meeting | Project Group Meeting for further progress reporting on development of a data registry for Rare Endocrine Conditions (EuRRECa) | 12/04/2021 | Meeting | https://eurreca.net/eurreca-annual-project-group-meeting-12th-april-2021/ | ||||||||||||||||||||
30 | Infrastructure | EuRRECa/EuRR-Bone platforms DROP-IN sessions | Drop-in sessions on by Zoom to learn more about e-REC (e-Reporting of Rare Conditions) and the Core Registry | 2nd Friday & 4th Wednesday of every month from start of 2022 to end of 2025 | Meeting | https://eurr-bone.com/news/ | ||||||||||||||||||||
31 | Infrastructure | European Network of Cancer Registries: Call for papers | A Research Topic on Data Quality and Harmonization Among European Population-Based Cancer Registries is open for manuscript submission. | 05/07/2022 | Call for proposals | https://www.encr.eu/news/research-topic-data-quality-and-harmonization-call-papers | ||||||||||||||||||||
32 | Infrastructure | European Network of Cancer Registries: Draft recommendation | The ENCR working group on basis of diagnosis has completed its work and proposes a new set of recommendations that are now in the consultation phase to the registries. | 20/05/2022 | Consultation | https://www.encr.eu/news/draft-recommendation-basis-diagnosis-consultation-registries | ||||||||||||||||||||
33 | Infrastructure | European Network of Cancer Registries: elearning modules | The European Network of Cancer Registries and the Joint Research Centre of the European Commission, in collaboration with eCancer, have developed six online modules for e-learning for cancer registrars. | Unscheduled | Launch | https://www.encr.eu/news/encr-e-learning-modules-cancer-coding | ||||||||||||||||||||
34 | Infrastructure | European Network of Cancer Registries: call for data | The JRC and the ENCR Steering Committee are organising a new data call to the European cancer registries, in order to update the cancer data available in the European Cancer Information System (ECIS). | 01/03/2022 - 31/01/2023 | Call for proposals | https://encr.eu/call-for-data | ||||||||||||||||||||
35 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 19/04/2021 | Meeting | https://www.encr.eu/news/76th-encr-steering-committee-meeting-minutes | ||||||||||||||||||||
36 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 11/02/2021 | Meeting | https://www.encr.eu/news/75th-encr-steering-committee-meeting-minutes | ||||||||||||||||||||
37 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 11/11/2020 | Meeting | https://www.encr.eu/news/74th-encr-steering-committee-meeting-minutes | ||||||||||||||||||||
38 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 10/06/2020 | Meeting | https://www.encr.eu/news/73rd-encr-steering-committee-meeting-minutes | ||||||||||||||||||||
39 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 04/03/2020 | Meeting | https://www.encr.eu/news/72nd-encr-steering-committee-meeting-minutes | ||||||||||||||||||||
40 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 17/01/2019 | Meeting | https://www.encr.eu/news/69th-encr-steering-committee-meeting-minutes | ||||||||||||||||||||
41 | Infrastructure | European Network of Cancer Registries: Steering Committee | Regular meeting to ensure development of European-wide cancer registries to im prove data collection and sharing. | 04/02/2018 | Launch | https://www.encr.eu/news/european-cancer-information-system-ecis-web-application-released | ||||||||||||||||||||
42 | Biobank and genomic data centralisation | Infrastructure | The Beyond 1 Million Genomes (B1MG) Project Kick-off | All the project board mobilised. Review and agree plan for the year ahead | 04/06/2020 | Launch | https://elixir-europe.org/news/elixir-launches-new-eu-project-b1mg | |||||||||||||||||||
43 | Infrastructure | The Beyond 1 Million Genomes (B1MG) Secure Cross-Border Technical infrastructure: March | Synthetic human datasets for safe cross-border testing | 01/03/2021 - 31/03/2021 | Launch | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
44 | Infrastructure | The Beyond 1 Million Genomes (B1MG) Stakeholder Meeting | Aims to strengthen the alignment amongst stakeholders and the 1+MIllion Genomes Initiative (1+MG) efforts | 17/11/2021 - 18/11/2021 | Meeting | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
45 | Infrastructure | The Beyond 1 Million Genomes (B1MG) Secure Cross-Border Technical infrastructure meeting: June | Meeting and workshop to define the security on federated data access processes | 01/06/2021 - 30/06/2021 | Meeting | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
46 | Infrastructure | The Beyond 1 Million Genomes (B1MG) Secure Cross-Border Technical infrastructure meeting: September | Meeting and workshop to define the synchronicity between regulation and technology | 01/09/2021 - 30/09/2021 | Meeting | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
47 | Infrastructure | The Beyond 1 Million Genomes (B1MG) European Commission review meeting | Meeting to review project progress and preparation for the B1MG summit and the mid-term review | 01/12/2021 - 30/12/2021 | Meeting | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
48 | Infrastructure | The Beyond 1 Million Genomes (B1MG) Secure Cross-Border Technical infrastructure meeting: March | Meeting to identify the barriers for existing cross-border data discovery and access solutions | 01/03/2021 - 31/03/2021 | Meeting | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
49 | Infrastructure | The Beyond 1 Million Genomes (B1MG) project: data governance | Publication of an iterative document on available best practices in sharing and linking phenotypic and genetic data | 01/05/2022 - 31/05/2022 | Meeting | https://b1mg-project.eu/news-events/ | ||||||||||||||||||||
50 | Infrastructure | The Beyond 1 Million Genomes (B1MG) project: publication | Report on the maturity level of national healthcare systems | 01/05/2022 - 31/05/2022 | Publication | https://b1mg-project.eu/work-packages/wp5 | ||||||||||||||||||||
51 | Infrastructure | The Beyond 1 Million Genomes (B1MG) project: tooling | Roadmap and guidance tool describes overall strategy and main steps for the adoption of genomic data in healthcare systems | 01/05/2023 - 31/05/2023 | Publication | https://b1mg-project.eu/work-packages/wp5 | ||||||||||||||||||||
52 | Infrastructure | The Beyond 1 Million Genomes (B1MG) project: policy briefs | Final policy briefs deliverable due | 01/03/2023 - 31/03/2023 | Publication | https://b1mg-project.eu/work-packages/wp6 | ||||||||||||||||||||
53 | Infrastructure | The Beyond 1 Million Genomes (B1MG): financing | Final report on design and funding routes to sustainability building on the work done by 1+MG and other initiatives | 01/03/2023 - 31/03/2023 | Publication | https://b1mg-project.eu/work-packages/wp6 | ||||||||||||||||||||
54 | Patient health records | Infrastructure | The EU Data Act | The Feb 2022 Data Act Proposal includes new regulations for patient health records (primary and secondary use) | 01/01/2022 - 01/01/2023 | Consultation | https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13045-Data-Act-amended-rules-on-the-legal-protection-of-databases_en | |||||||||||||||||||
55 | First European Health Data Space (EHDS) Consultation | Public consultation focused on the access to and use of health data for healthcare provision, research and innovation, policy-making and regulatory decision | 03/05/2021 - 26/07/2021 | Consultation | https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-A-European-Health-Data-Space/public-consultation_en | |||||||||||||||||||||
56 | Second European Health Data Space (EHDS) Consultation | Proposal for a new governing framework for health data in Europe | 04/05/2022 - 06/07/2022 | Consultation | https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12663-Digital-health-data-and-services-the-European-health-data-space_en | |||||||||||||||||||||
57 | Medicine/pharmaceutical registers | Infrastructure | European Medicines Agency’s (EMA) new emergency task force (ETF) for crisis preparedness meeting | Task force becomes fully operational in mid April | 01/04/2022 - 30/06/2022 | Meeting | https://www.ema.europa.eu/en/news/ema-management-board-highlights-march-2022-meeting | |||||||||||||||||||
58 | Patient reported outcomes data | Infrastructure | Publication guiding the building of patient preference study design | Guidance on methodology on recent developments (e.g., IMI PREFER) of appropriate methods for patient preference study design, conduct, analysis, and presentation for regulatory purposes, ensuring high quality methodology and independence | 01/04/2022 - 01/01/2025 | Publication | https://www.imi.europa.eu/projects-results/project-factsheets/prefer | |||||||||||||||||||
59 | Infrastructure | European Medicine Agency (EMA) publication providing strategic reflection on current roadmap | Discussion of progress towards implementing patient reported outcomes across Europe. | 01/04/2022 - 01/01/2025 | Publication | https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf | ||||||||||||||||||||
60 | Open science/open clinical data | Infrastructure | European Open Science Cloud (EOSC-Life) publishes FAIR data and service catalogue | Project will publish ‘FAIR’ data and a catalogue of services provided for the management, storage and reuse of data in the European Open Science Cloud (EOSC) | 01/04/2022 - 30/06/2022 | Publication | https://www.eoscsecretariat.eu/press-office/science-business-eu-science-cloud-project-get-%E2%82%AC950m-investment | |||||||||||||||||||
61 | Infrastructure | Gaia-X Health Data Space Event | Gaia-X's data spaces integrate existing data initiatives in a federated structure and invite new initiatives to join the federation, to progress medicine, reduce costs and improve health for all | 04/04/2022 | Conference | https://www.gaia-x.eu/news/events/enable-future-health-federated-citizen-centric-and-insight-driven | ||||||||||||||||||||
62 | Infrastructure | A New European Innovation Agenda | This initiative builds on strong foundations to address the scale-up financing gap; need for regulation to enable innovation in rapidly evolving fields | 01/04/2022 - 31/05/2022 | Consultation | https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13437-A-New-European-Innovation-Agenda_en | ||||||||||||||||||||
63 | Insurance claims data | Infrastructure | European Social Security Pass pilot project publication | European Social Security Pass is being piloted and will deliver its first results during the first half of 2022 | 01/01/2022 - 30/06/2022 | Publication | https://ec.europa.eu/social/main.jsp?catId=1544&langId=en | |||||||||||||||||||
64 | Personal and health technologies data | Infrastructure | EUnetHTA Joint Scientific Consultations (JSC) | Health technology assessments (HTAs) and consultations | 01/06/2022 - 31/08/2022 | Consultation | https://www.eunethta.eu/eunethta-21-launches-2nd-open-call-for-jsc-in-june-2022/ | |||||||||||||||||||
65 | Joint Clinical Assessment (JCA) Publication | Publication of health technology and clinical assessments (HTAs and JCAs) | 01/07/2020 - 31/07/2020 | Publication | https://www.eunethta.eu/national-implementation/national-uptake-and-case-studies/ | |||||||||||||||||||||
66 | Infrastructure | Creation of MyHealth@EU platform | Facilitating the provision of better cross-border healthcare, continuity of care and ensuring access to safe and high-quality healthcare; and supporting citizens’ security and trust. | 01/04/2022 - 30/06/2022 | Call for proposals | https://ec.europa.eu/assets/sante/health/funding/wp2022_en.pdf (page 32) | ||||||||||||||||||||
67 | Real World Data (RWD) infrastructure | Infrastructure | European Medicines Agency’s (EMA) catalogue: real world data sources and analyses | Launch of EMA's first Real World Data public catalogue featuring an agreement on Real World Metadata for regulatory purposes | 01/02/2022 - 28/02/2022 | Publication | https://www.ema.europa.eu/en/documents/work-programme/workplan-2021-2023-hma/ema-joint-big-data-steering-group_en.pdf | |||||||||||||||||||
68 | Infrastructure | The Beyond 1 Million Genomes (B1MG) project: data access | Secure data access demonstrator coordinated across existing initiatives projects for cross-border data access | 01/05/2022 - 31/05/2022 | Launch | https://b1mg-project.eu/work-packages/wp4 | ||||||||||||||||||||
69 | Infrastructure | Creation of a new and decentralised EU-infrastructure | Infrastructure for secondary use of health data (HealthData@EU) that will connect health data access bodies will be set up in all Member States | Unscheduled | Launch | https://ec.europa.eu/health/system/files/2022-05/com_2022-196_en.pdf (page 10) | ||||||||||||||||||||
70 | Infrastructure | Pilot of EU-infrastructure for secondary use of health data | All EU Member States will be required to participate in the EU-infrastructure for secondary use (HealthData@EU) to facilitate cross-border studies. This infrastructure will be piloted in a EU4Health project starting in 2022 | 25/01/2022 | Launch | https://ec.europa.eu/health/system/files/2022-05/com_2022-196_en.pdf (page 11) | ||||||||||||||||||||
71 | Infrastructure | Publication of RWD public catalogue | Expected launch of public real world data catalogue by European Medicines Agency as part of DARWIN and TEHDAS initiatives | 01/08/2022 - 31/08/2022 | Launch | https://www.ema.europa.eu/en/documents/work-programme/workplan-2021-2023-hma/ema-joint-big-data-steering-group_en.pdf | ||||||||||||||||||||
72 | Infrastructure | Developing and using DARWIN EU | Expected initiatives to include: launch publicly-available DARWIN EU website; work with established data permit authorities; test business process to access and analyse healthcare data; and run pilot studies to support more EMA committees. | Unscheduled: 2023 | Launch | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
73 | Infrastructure | DARWIN EU full operation mode | Expected to include: conduct studies and answer questions to support EMA scientific committees and national competent authorities; and ARWIN EU fully operational with involvement of data partners and medicine regulators. | Unscheduled: 2024 | Launch | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
74 | Infrastructure | Leverage the EU Health Data Space | Increase geographical coverage, scope and regulatory uses of healthcare data in DARWIN EU | Unscheduled: 2025 | Launch | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
75 | Infrastructure | The Beyond 1 Million Genomes (B1MG) Stakeholder Portal launches | The Stakeholder Coordination Portal launches so stakeholders can exchange ideas and connect to other leaders in the project. This involves experts from relevant groups working together to improve the project outcomes. | 24/11/2020 | Launch | https://ecrin.org/news/b1mg-launches-stakeholder-portal | ||||||||||||||||||||
76 | Real World Evidence (RWE) infrastructure | Infrastructure | RWE guidance publication for integration pilots | Publication of registries guidance - Roadmap for RWE guidance agreed | 20/01/2022 | Publication | https://www.ema.europa.eu/en/documents/other/hma-ema-joint-big-data-taskforce-phase-ii-report-evolving-data-driven-regulation_en.pdf | |||||||||||||||||||
77 | Infrastructure | Heads of Medicine Agency (HMA) and European Medicines Agency’s (EMA) Joint Big Data Steering Group (BDSG) Workplan | This workplan includes a brief description of each topic and deliverables. The plan was based on the BDSG mandate and is structured in line with the key recommendations of the Big Data Task Force | 27/07/2020 | Publication | https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/Big_Data/2020_09_HMA-EMA_Big_Data_SG_Workplan.pdf | ||||||||||||||||||||
78 | Infrastructure | Heads of Medicine Agency (HMA) and European Medicines Agency’s (EMA) Joint Big Data Steering Group (BDSG) 2021 report | Report provides a summary of the key activities and achievements of the BDSG in 2020. Documents significant progress in the transformation to more data-driven regulation in line with the Network Strategy to 2025 | 12/03/2021 | Publication | https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/Big_Data/2021_03_HMA-EMA_Big_Data_Steering_Group_2020_report.pdf | ||||||||||||||||||||
79 | Infrastructure | Heads of Medicine Agency (HMA) and European Medicines Agency’s (EMA) Joint Big Data Steering Group (BDSG) 2020 report | Report provides a summary of the key activities and achievements of the BDSG in 2021. Significant progress in the transformation to data-driven regulation continued in 2021, in line with the Network Strategy to 2025 and BDSG workplan | 20/02/2020 | Publication | https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/Big_Data/2022_04_HMA-EMA_Big_Data_Steering_Group_2021_report.pdf | ||||||||||||||||||||
80 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Launched | The European Medicines Agency (EMA) established a coordination centre to provide evidence on the use, safety and effectiveness of medicines.This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU). | 04/06/2021 | Launch | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
81 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: June 2021 | The Advisory Board provides strategic advice and recommendations to the DARWIN EU project team on the establishment of the DARWIN EU capability and its use of the European Health Data Space. | 28/06/2021 | Meeting | https://www.ema.europa.eu/en/events/darwin-eu-advisory-board-meeting-28-june-2021 | ||||||||||||||||||||
82 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: September 2021 | The Advisory Board provided updates and discussed the European Commission's legislative and policy initiatives | 20/09/2021 | Meeting | https://www.ema.europa.eu/en/events/darwin-eu-advisory-board-meeting-20-september-2021 | ||||||||||||||||||||
83 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: November 2021 | The Advisory Board provided updates and discussed a benefits analysis, and the European Commission's initiatives and legal proposals | 12/11/2021 | Meeting | https://www.ema.europa.eu/en/events/darwin-eu-advisory-board-meeting-12-november-2021 | ||||||||||||||||||||
84 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: February | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | 16/02/2022 | Meeting | https://www.ema.europa.eu/en/events/darwin-eu-advisory-board-meeting-16-february-2022 | ||||||||||||||||||||
85 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: quarterly meetings: April | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | 20/04/2022 | Meeting | https://www.ema.europa.eu/en/events/darwin-eu-advisory-board-meeting-16-february-2022 | ||||||||||||||||||||
86 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: June | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2022 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
87 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: September | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2022 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
88 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: February | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2022 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
89 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: quarterly meetings: April | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2022 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
90 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: June | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2022 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
91 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: September | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2022 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
92 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: February | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2023 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
93 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: quarterly meetings: April | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2023 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
94 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: June | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2023 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
95 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: September | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2023 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
96 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: February | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2024 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
97 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: quarterly meetings: April | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2024 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
98 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: June | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2024 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
99 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: September | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2024 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu | ||||||||||||||||||||
100 | Infrastructure | Data Analysis and Real World Interrogation Network (DARWIN EU) Advisory Board meeting: February | The Advisory Board provided updates and discussed the communication strategy and use cases for DARWIN EU. Held quarterly. | Unscheduled: 2025 | Meeting | https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu |