Pharmacogenomics is the study of genetic variability affecting an individual’s response to a drug. Its use allows personalized medicine and reduction in ‘trial and error’ prescribing leading to more efficacious, safer and cost-effective drug therapy. The U-PGx consortium will investigate a pre-emptive genotyping approach (that is: multiple pharmacogenomic variants are collected prospectively and embedded into the patients’ electronic record) of a panel of important pharmacogenomic variants as a new model of personalised medicine. To meet this goal we combine existing pharmacogenomics guidelines and novel health IT solutions. Implementation will be conducted at a large scale in seven existing European health care environments and accounts for the diversity in health system organisations and settings. Feasibility, health outcome and cost-effectiveness will be investigated. We will formulate European strategies for improving clinical implementation of pharmacogenomics based on the findings of this project.

Lack of specific relevant know-how in regulatory science delays the development of new treatment strategies or limits the chances that promising innovations will reach patients. STARS aims to improve the direct regulatory impact of results obtained in medical research. Seventeen European countries are represented in the consortium through their national competent authorities, alongside academic and industry representatives, and associations with relevant experience. The work plan includes the development of a Comprehensive Inventory of existing support activities based on a detailed analysis of the currently established programmes. This analysis is also the basis for development of a Common Strategy to strengthen regulatory sciences and two curricula, the Core Curriculum specifying essential knowledge for the professional training of clinical scientists and the Comprehensive Curriculum defining relevant knowledge for specific post-graduate programmes. Three pilot projects aim (i) to transfer an identified bes

Haematological malignancies (HM), also known as blood cancers, are a heterogeneous and complex group of multicausal diseases that can’t be easily diagnosed nor treated. Nowadays most treatments are extremely complex, and advances in patient diagnosis and therapies slow due to the low number of patients per centre. Thus, there is a need to harmonise, store, and analyse the current HM information to speed-up and support the decision-making process for patients’ access to new therapies. HARMONY PLUS takes advantage of the capabilities of the HARMONY Big Data platform to match this unmet needs by expanding its scope to incorporate myeloproliferative neoplasms, including chronic myeloid leukemia, polycythaemia vera, essential thrombocythaemia, and myelofibrosis; and lymphoproliferative disorders, including Hodgkin’s lymphoma, Waldenström macroglobulinemia and all the other rare HMs not covered by HARMONY Project. In parallel, HARMONY PLUS will continue to refine and define the Core Outcome Sets (COS), especially for these new HMs to ensure the use by researchers of useful common outcomes relevant to all stakeholders. As previously accomplished in HARMONY, HARMONY PLUS is committed to pursue the maximum ethical and legal requirements, particularly to ensure patient’s right to privacy. Data-driven research within Europe will be enhanced by converting the current HARMONY platform into an Integrated Services Platform to serve as a valuable tool to support clinical trial design and use of available data as a control arm. This platform, combined with a HaemoDatabank repository with information about HMs patient biological samples across Europe, will facilitate a more efficient research and clinical trial design, and consequently will promote collaborations with recognised databases outside Europe. From the regulatory point of view, HARMONY PLUS will be a valuable technology tool during the evaluation of new treatments and drugs by also considering the patients’ needs.

X-eHealth’s project stands herein for a project of strategic relevance for tomorrow’s European eHealth Union. Assembling at the time of this proposal submission a shared commitment of 47 health actors, the underlying idea of this project is to develop the basis for a workable, interoperable, secure and cross border Electronic Health Record exchange Format in order to lay the foundation for the advance of eHealth sector while using the 3 pillars put forward by the EC as reference. Aimed at promoting a faster and sustainable EU digital transformation, this Cooperative and Support Action is made up of 8 Work Package in which 4 exclusively focus on technical-functional activities (WP4 to WP7). From Generic Aspects to System Architecture and Integration, passing by Functional and Technical Specifications, X-eHealth objective is to move towards a uniform interoperable data-sharing format framework. In addition, to enhance EU’s public health state of play, WP1 and WP8 are responsible for implementation studies, practicality and continuity of eHealth interoperability development. On this basis and building upon the already in place Patient Summary, X-eHealth purpose is to develop the foundations for a common framework for medical imaging, discharge letters, laboratory results and rare diseases to flow both alongside citizens care pathway and across health entities between EU Member States and Neighbour Countries. Focus on cross-border services, this consortium aims to advance an interoperable Common European Health Data Space for citizens and health providers engagement in accordance with privacy and cybersecurity regulations. To achieve this end, X-eHealth gathers 36 consortium partners plus 5 collaborative partners and 6 eHealth skilled experts, eager to develop the abovementioned 4 domains, and distinguished by policy and political actors mixed with national competent authorities to indeed concretely plan, implement and maintain national eHealth infrastructures.