www.eurordis.org               EPIRARE:Building Consensus and Synergies for theEU Registration of Rare Disease Patients   ...
The EPIRARE project    General Objectives:    To build consensus and synergies to address the regulatory,     ethical and ...
The EPIRARE project    A 30-month project    Coordinated by the    Istituto Superiore di Sanità (ISS) (Italian Ministry of...
The EPIRARE project    Organisation of the work:           WP1- Coordination of the project           WP2 - Dissemination ...
The EPIRARE project                             WP1- Coordination of the                                     project      ...
The EPIRARE projectWP8 – Current needs of EU registration on RD and platform           facilities serving registration nee...
The EPIRARE project                           WP4 - Legal basis       • This WP will assess the current transposition of t...
The EPIRARE projectWP6 - Common data set and disease specific data collection        • This WP defines a common data set w...
The EPIRARE projectWP7 - Data quality, validation and data sources integrationThis WP assesses:a) the internal and externa...
The EPIRARE projectWP5 - Policy Scenarios on the scope aims, governance and       sustainability of registration of RD pat...
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Workshop 3 - "Presentation of the Epi-Rare project"

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Workshop 3 - Registries
"Presentation of the Epi-Rare project"
Yann le Cam, EURORDIS

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Workshop 3 - "Presentation of the Epi-Rare project"

  1. 1. www.eurordis.org EPIRARE:Building Consensus and Synergies for theEU Registration of Rare Disease Patients Yann LE CAM Chief Executive Officer EURORDIS
  2. 2. The EPIRARE project General Objectives: To build consensus and synergies to address the regulatory, ethical and technical issues associated with the registration of rare disease patients in Europe. To explore the feasibility of registration of minimum data set common to all rare disease To elaborate possible policy scenarios for EU policy on rare disease patients registries To prepare the feasibility of a future EU registry platform (legal basis, governance framework, option for sustainability, …).2 The EPIRARE Project
  3. 3. The EPIRARE project A 30-month project Coordinated by the Istituto Superiore di Sanità (ISS) (Italian Ministry of Health) + 2 private organisations 10 Associated Partners: 8 public institutions Total budget of 1.1M€ (60% of which from the European Commission)3 The EPIRARE Project
  4. 4. The EPIRARE project Organisation of the work: WP1- Coordination of the project WP2 - Dissemination of the project WP3 - Evaluation of the project WP4 - Legal basis WP5 - Policy Scenarios on the scope aims, governance and sustainability of registration of RD patients WP6 - Common data set and disease specific data collection WP7 - Data quality, validation and data sources integration WP8 – Current needs of EU registration on RD and platform facilities serving registration need4 The EPIRARE Project
  5. 5. The EPIRARE project WP1- Coordination of the project WP8 – Current needs of EU registration on RD and platform facilities serving registration need WP6 - Common data set and WP4 - Legal basis disease specific WP7 - Data quality, data collection validation and data sources integration WP5 - Policy Scenarios on the scope aims, governance and sustainability of WP2 - registration of RD patients WP3 - Dissemination of Evaluation of the project the project5 The EPIRARE Project
  6. 6. The EPIRARE projectWP8 – Current needs of EU registration on RD and platform facilities serving registration needA survey to be conducted through existing registries, in order to collect information on existing registration initiatives within the interests not only of academicians and private companies, but also of the patients. Addressed aspects: scope and aims, legal base for collection of data, measures for data protection, organisational and financial support, number of patients registered, unmet needs, data collected, means of collection and quality of data and data sources.A survey, conducted by EURORDIS, will also address experience and expectations of patients organizations regarding patient registries run by academic groups, industry or public administrations.The information collected will be used to identify the services necessary to improve the quality, promote and facilitate the use of the registry platform and to report appropriately to the public and other stakeholders. 6 The EPIRARE Project
  7. 7. The EPIRARE project WP4 - Legal basis • This WP will assess the current transposition of the Data Protection Directive and in particular the transposition of Art. 8 of the Directive, • will consult EUCERD Member and other national policy makers and • will set out the elements (e.g.: scope of data collection, the nature of data to be collected, the data sources to be used) to generate a policy option (best practice model) which can be assured and implemented by national policy makers / institutions.7 The EPIRARE Project
  8. 8. The EPIRARE projectWP6 - Common data set and disease specific data collection • This WP defines a common data set with correlated Standard Operating Procedures, which is independent of the registered rare disease, and of other disease- specific modules, in order to provide information consistent with the agreed scope of the registers which is useful for public health actions and for other aims.8 The EPIRARE Project
  9. 9. The EPIRARE projectWP7 - Data quality, validation and data sources integrationThis WP assesses:a) the internal and external validity of existing data as well as the use of primary or secondary data sources and completeness of follow-up.b) the need for performing an external quality control scheme to monitor compliance of platform registration activities to inclusion criteriac) the need for the transnational pooling of collections on RD patients, in order to attain sufficient statistical power for clinical and public health investigationsc) the necessary data source integration and completeness of reporting to get reliable results with respect to different aims and data analysis and ways to assess it.d) the opportunities offered by the collaboration of patients and POs in increasing the completeness of case registration.9 The EPIRARE Project
  10. 10. The EPIRARE projectWP5 - Policy Scenarios on the scope aims, governance and sustainability of registration of RD patients • This WP addresses the scope, aims, governance and ownership of RD patient registration and develop possible policy scenarios. • Consensus will be build toward an agreed “common data set” for all RD registries and databases • Different options ensuring the long-term sustainability of the RD registers without affecting the independence and scientific value of the registration activities and products will also be assessed. • This work will be conducted by EURORDIS – ISS and all project partners - in close relation with the EUCERD, and it will support a specific workshops on “registries and data bases”.10 The EPIRARE Project
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