Regulatory T cells (Tregs) are important therapeutic targets for many immunopathologies. Stimulating Tregs with interleukin-2 (IL-2), the key cytokine supporting Treg fitness, is being actively developed, but is likely to be insufficient to achieve optimal therapeutic efficacy in severe diseases. This is why many groups are developing Treg cell-based therapies, harnessing the experience accumulate during the development of CAR T cell therapies for cancer. In this emerging field, we propose to develop an innovation aimed at generating enhanced-Tregs (e.Tregs) by rendering them IL-2 self-sufficient. We have already proven that, compared to control Tregs, e.Tregs expressing a mutated IL-2 (IL-2N88R) that cannot activate Teffs (i) survive much better in IL-2 deprived environments, (ii) are more stable in phenotype and (iii) have a much better therapeutic efficacy. We will complete the preclinical development of e.Tregs and perform a first-in-man dose-escalation phase-I/II study in chronic graft-versus-host-disease (cGVHD).For this purpose, we will (i) finalize the optimal design of the lentiviral vector to be used, including addition of a suicide gene; (ii) optimize the entire process to select, gene-modify and expand Tregs under good manufacturing practices (GMP) and (iii) perform a dose-escalation phase 1/2 study in patients with cGVHD. The partners are experts in stem cell transplantation and cell therapy who have developed their own academic production of CAR T cells for leukaemia, used in more than 400 patients. They will translate their know-how to e.Tregs.We aim to validate a new therapeutic approach for the treatment of cGVHD, a condition with high mortality and morbidity and unmet clinical needs. Furthermore, we expect that our results will motivate researchers to harness the e.Treg technology in their products, notably CAR Tregs.This should have a major impact by enabling more effective therapies for high-burden diseases or disorders with unmet medical needs.

<< Background >>Over the last 20 years, genetic tests have gained importance in personalized medicine and disease prevention especially to healthy individuals who have a family history of disease or patients who may have a disease resulting from a genetic mutation (Klein, 2020). At-risk relatives of the 30 million Europeans affected by genetic conditions may be neither recognised nor managed appropriately due to the lack of knowledge about genetics and the few trained health care professionals (HCP) (McAllister et al, 2015). This contravenes the EU’s aim and the European Society of Human Genetics’s goals to create safe, efficient, patient-centered and sustainable healthcare systems (European commission Innovation Union, 2011). On the other hand, research has demonstrated that genetic testing for Neurodegenerative Disorders (ND) for asymptomatic relatives of people with neurodegenerative disorders (PwND) for specific genes and mutations can be valuable and safe in certain contexts. However, individuals’ understandings about what genetic susceptibility tests can achieve, what they cannot achieve, and the risks they pose should be more realistic after testing than beforehand (Christensen, et al, 2018). A lot of studies have shown that genetic testing increases risks for psychological harm, even among individuals who are at risk or positive for risk genes of ND, may elicit grief, distress, conflict, sadness, relief, guilt, uncertainty and ambivalence and that depends on the way that HCP disclose the genetic information (Rostamzadeh, et al, 2019). Nevertheless, when well informative and supported Genetic Counseling (GC) sessions take place, the genetic information can cause behavioral, day life changes (diet, vitamins/medications, physical activity) and enhance decision making that can work as predictive measures for the diseases. Nowadays, because of the lack of trainings on GC on ND, few HCP are prepared to address the genetic risks and to manage the psychological impact of the disclosure to relatives (Manrique de Lara et al, 2018). Given the increased incidence of ND, the availability of Direct to Consumer Testing and the development of precision medicine, an increased demand for high-quality information on ND genetics likely provided in the form of GC by well-trained health care professionals (HCP), is anticipated. All these global trends and challenges of genetic testing affect Higher Education Institutions (HEI)’s and their departments in the field of health as they aim to equip their students to become societal involved, well-educated HCPs. There is a crucial need to use the existing knowledge and experiences from a variety of disciplines in the field of genetics to build an innovative learning method and course which will include the best practice guidelines on how future HCP need to implement GC, which is the most appropriate method to introduce genetic testing to patients and people at genetic risk. The main aim and central impact of this project are to support people and society to better understand the aims of genetic testing and the usefulness of genetic counseling by involving students in an innovative learning and teaching setting. This project will provide the opportunity to take all the factors of an appropriate training course to society into account by involving the families of PwND in the development of the learning and teaching outcomes consequently improving their visibility and enhancing their level of knowledge.<< Objectives >>- Developing the “Best Genetic Counseling protocol” and specific Methodological Guidelines which will combine a huge number of similar European protocols. -Creating an innovative European Course which will be available on a Service System that can be easy integrated into HEI’s platforms.- Developing a Course that will combine online and classroom methods to prepare and learn students about the different facets of GC and how to offer GC services in the best possible way. -Students will gain new competencies and knowledge and bring new skills into practice related to communication, empathy, and support, while they make contact with families of PwND and offer GC services.-Supporting families of PwND by offering them a GC innovative approach which will combine knowledge enhancement and more person-centered process with the establishment of genetic knowledge, decision making and psychological support.- Enhancing genetic literacy and understanding of the general public as well as behavioral and day life changes (diet, vitamins, physical activity) that can work as predictive measures for ND. -Contributing on the goals of an effective and safe GC approach by combing a common, safe and efficient protocol with the new knowledge and skills of young health care professionals (students)-Enhancing interconnected care/medicine and establishing a multidisciplinary approach by the contribution of a critical mass of experts and health care professionals.-Setting the framework for the establishment of training and knowledge exchange.-Enhancing scientific and clinical careers in neurodegenerative GC in the future. -Translating genetics into improved health outcomes and benefits for families.-Trialing and implementation of a new model of GC in Europe.-Adapting the new GC intervention as a routine care service in European institutions and establishing the foundations for the integration of GC services across Europe.-Asking for the introduction of new policies and regulations supporting the introduction of GC Courses in HEIs and other institutions and the GC services where this is not present.-Empowering of families and young health professionals (students) to be actively involved participants of the genetically oriented society.-Enhancing and promoting the use of Telegenetics as part of remote GC services<< Implementation >>Project activities will follow a well-structured path and will be subsequent and interconnected, divided work packages (WP) and tasks with responsible partners who will lead the work and divide responsibilities among the partners. In each WP different tasks are described to facilitate the reaching of the outcomes. Leaders of each WP will monitor the progress within the WP and will be responsible for the timely delivery and quality assurance of PR The following WPs and activities have been defined: WP1 Management and Implementation –Leader: AUThWP2 Development of GC Methodology (PR1) –Leader: UHEIExperts in the field of GC (P.I.N.Dis and FFCRB) will share their existing GC protocols and partnership will create the final European Guidelines. A needs analysis, involving a large variety of participants from care and patient organizations (families of PwND), diagnostic institutions and genetic laboratories (HCPs) will be contacted in order to define their needs and the specifications of the protocol. The Transnational Implementation Guidelines including ¨Best GC Protocol” will be the final result of this WP.WP3 Development and design of the GECONEU course and material (PR2) – Leader: VUBBased on the specifications from WP2 and also a Cross-country comparison of the courses in partnerships universities, the GECONEU course and material will be developed and designed. Feedback from end-users from the Needs analysis study will be used for the creation of this WP. The PR will be the course material that will be used for the pilot (PR4).WP4 Design, Development and Testing of a Service System (PR3) – Leader: AUThBased on the specifications from WP2, the service system which will be included in the e-learning platform will be developed and designed. It will make it possible to combine online digital media with traditional classroom methods. With the service system and the e-learning platform, students not only have control over time, place, path, and pace, but it also allows for a combination of classroom practices with computing mediated activities regarding content and delivery. The PR of this WP will be the software of the learning platform that can be used for the pilot. WP5 Pilot (PR4) –Leader: IEUIt contains the tasks related to piloting the new and innovative course in 4 HEI’s and local care facilities. A group of students will take part in the course and perform the pilot. It will support the sustainability and replicability of the material and service system of the learning platform. A Learning Teaching Training Activity will be organised before the Pilot in order to train teachers in the GECONEU Course. WP6 Evaluation and monitoring of the project objectives and impact – Leader: FCRBThis WP monitors the progress of the project to meet the objectives on a continuous basis. Standardized measures, such as questionnaires, will be used to evaluate the acceptability of the course and the blended learning platform. This WP will be a comprehensive report that is the basis for further development in the project.WP7 Dissemination –Leader:P.I.N.DisThis WP concerns the ongoing dissemination of the project and the PRs at the local, national and EU level. Partners will continuously disseminate the ongoing and PRs at their local level and within their organizations. 5 Multiplier Events will be organised (one in each country) to spread the PR.<< Results >>The project is divided into different WPs with different PRs. These PRs lead to the following main 4 outcomes: ¨Best GC Protocol” in Europe (PR1)Experts in the field of GC will share their existing GC protocols and partnership will create the final European Guidelines. A needs analysis, involving a large variety of participants from care and patient organizations (families of PwND), diagnostic institutions and genetic laboratories (HCPs) will be contacted in order to define their needs and the specifications of the protocol. The Methodological Guide will be the final result.An innovative creative course (PR2 and PR4)The project will develop an innovative interactive course that can be part of the curriculum of HEI’s in Europe. This will be done by involving care organizations, families, HCPs in the field of neurology, genetics and psychology in a co-design process, bringing theory and practice together, and taking the workplace as a starting point for new course material in education. Service System for Universities' e-learning platforms (PR3)The training material of the course will be offered through a Backend-as-a-Service (SaaS), which will be able to integrate into any e-learning platforms, increasing the sustainability and impact of the results of the project, while promoting the competencies of students and giving them the possibility to exchange results internationally. Guideline hand book (PR4)Finally, the result will be a guideline handbook, that helps HEI’s across Europe to implement the training, the service system and the teaching material, supporting the impact, replicability and sustainability of GECONEU outcomes. This handbook will be set up based on extensive testing of the learning material and service system in pilots and experiences of 4 different faculties in 4 countries. The handbook will facilitate the implementation in HEIs throughout Europe. Based on these main objectives GECONEU aims to tackle the following impacts outcomes: - Students will become aware of GC related issues and problems. Their concept of the way to counsel will change through this learning method and they will be motivated to work in GC field. The social engagement of HEI’s is increased and students gain civic competences. - When students become HCP they will be able to apply the course content in their work. This method is beneficial for the job satisfaction of HCPs who practice GC. - Families’ fear, anxiety, distress and depression during the disclosure of genetic testing results and after will be decreased through the person-centered approach and the enhancement of health literacy. - Raising the awareness and knowledge of the public about genetic testing and its benefits and risks. Enhance decision-making in the field of health and genetics and increase public health literacy.- Young HCPs and families of PwND will be brought together in this GC approach, increasing the understanding of psychological needs and improving the communication conditions between families, caregivers and the medical supervisor. In this way, the social engagement of students and the link with the real world in clinical practice will be increased. - Evidence regarding the potential benefit and harms of genetic testing and counseling to inform medical practice and health policy.- Creation of EU networks, harmonization of training practices according to good practices shared. Partners and associated partners are about to establish communication channels for exchanging and developing existing successful for the students innovative methods and educational material.- Telegenetics services in the new service system will increase the accessibility of GC services and tackle the lack of GC services in Europe.- Provide information to design appropriate health programs that will reduce the ever-increasing burden of inherited diseases and improve the effectiveness of the national healthcare system.

<< Background >>Clinical reasoning is the ongoing process in which a nurse/midwife quickly and accurately assesses a care situation by collecting cues, making the right observations, process the information and come to an understanding of a patient problem, plan and implement interventions, taking the right actions with the right goal in mind, evaluating outcomes and reflecting on and learning from this process (Levett-Jones et al., 2010).Nurses/midwifes play a critically important role in patient care, they are at the forefront of monitoring patients for clinical deterioration, understanding care processes and performing countless other tasks to ensure patients receiving high-quality care. Having adequate clinical reasoning skills is important since nurses/midwifes with effective clinical reasoning skills have a positive impact on patient outcomes. Conversely, those with poor clinical reasoning skills often fail to detect impending patient deterioration resulting in a “failure-to-rescue” (Aiken, Clarke, Cheung, Sloane & Silber, 2003). Errors in clinical judgment, in assessing a care situation and taking decisions make up to 60% of adverse clinical events. Nurses/midwifes vigilance at the bedside is essential since they are the only caregiver who provide 24hr care. Furthermore clinical reasoning increases providing person-centered care which enhances healthcare quality and safety (Rossiter et al., 2020). We aim to gain insight in nursing/midwife students and registered nurses/midwifes understanding of clinical reasoning across various EU countries. We will describe the various teaching models for nursing/midwife students across EU countries and exchange good practices.University colleges are committed to the education of nurses/midwifes who are being adequately prepared to work in complex and challenging clinical environments (Levett-Jones et al., 2010). Nursing/midwifery education increasingly invests in teaching students effective clinical reasoning skills. The importance of teaching clinical reasoning are multidimensional but include the difficulties beginning nurses encounter when differentiating between a clinical problem that needs immediate attention and one that is less acute (del Bueno, 1994); and a tendency to make errors in time sensitive situations where there is a large amount of complex data to process (O‟Neill, 1994). In spite of this effort, US and Australian research demonstrated poor appropriate clinical reasoning and critical thinking skills in newly graduated nurses (del Bueno, 2005; del Bueno, 1994; O'Neill, 1994). We do not have data on the level of clinical reasoning of newly graduated students in the EU. Furthermore there is limited knowledge on used teaching strategies within the EU, therefore there is a need for understanding the interpretation of clinical reasoning among students and registered nurses/midwifes in the EU, teaching models and good practices on teaching clinical reasoning in nursing/midwifes education in other EU university colleges. There are frameworks and tools available that can enhance and support clinical reasoning (e.g. the Levett-Jones clinical reasoning circle, proactive nursing by Bakker). However, these frameworks and tools needs to be adjusted to an EU context, we need to describe and exemplify the process of clinical reasoning within an EU context. Exchanging teaching methods and good practices between colleges within different European countries would therefore be of great added value.Despite the importance of developing and subsequently measuring clinical reasoning skills, little is known about the reasoning skills of nurses/midwifes. Furthermore there seems to be a gap between the clinical reasoning framework used by experienced nurses and nursing students. We therefore aim to close this gap between experienced nurses/midwifes understanding of clinical reasoning and nursing/midwifes students understanding of clinical reasoning.<< Objectives >>This project will for the first time bring together European university colleges on nursing and midwifery education and enable them to exchange and co-create a framework, training course and a curriculum on clinical reasoning. We aim to close the gap between experienced nurses/midwifes understanding of clinical reasoning, nursing/midwifes students understanding of clinical reasoning and consequently care institutions (e.g. hospitals, primary care) and nursing education. The project will be dealing with both nursing and midwifery professions, thus allowing for experience to be shared across.The expected impact of the project is divided into learners, project staff, partner organisations and systemic (health organisations). The learners in this project are students and lecturers from the participating organisations on the one hand and professionals from care organisations on the other. The three groups will be intensively involved during the project, e.g. development of project results, training activities and multiplier events. During the project, e.g. development and training, the learners gain knowledge and skills in clinical reasoning. This allows them to sharpen their clinical reasoning competencies. They will be introduced to the theoretical framework of clinical reasoning and will be able to contribute to the closure of the gap between basic education at the higher education institutes and clinical practice. In addition, they are given user-friendly guidelines on how to get started with clinical reasoning in their own organisation or on the workplace. It is important to note that during the project, examples and case studies from different care settings are used. This enables the transfer of preventive, diagnostic, acute and chronic treatment and follow-up settings to the learners and no care setting is excluded.The project will therefore pay attention to growing towards a common ground of clinical reasoning and taking into account the similarities and differences between the participating countries with regard to education and care settings. The staff involved will also develop the knowledge, skills and competences of clinical reasoning as mentioned above under 'learners' as they will be involved from the very first row in the development and management of the project. In addition, they will expand or sharpen their competences in cooperation, planning and coordination, decision making, English language, hybrid teaching methods, care delivery, quality and risk management.The partner organisations will have a new offer of (lifelong) learning for their students, lecturers and surrounding care organisations. The training in clinical reasoning will be built into the basic education of the students, will be offered as a lifelong learning programme for their own teachers and for health care professionals. This new offering will be guided by an evidence-based theoretical basis and guidelines to get started with clinical reasoning. The offer of lifelong learning in clinical reasoning goes beyond a basic course. By offering a champion course we want to create a ripple effect for several higher education institutions and care organisations.With this project we want to increase the clinical reasoning skills of students and professionals on the one hand and close the gap between the clinical reasoning skills of students and professionals on the other hand. To achieve this we want to raise the awareness of clinical reasoning in health care organisations by training ambassadors or champions. They are the key persons to initiate change in the educational and healthcare landscape. This will first change the education and care of the participating partners and their network, and then move on to other networks (e.g. hospital networks, home care networks, primary care networks). The impact of the project will be measured on four levels of training evaluation using Kirkpatrick's model (see measurements impact).<< Implementation >>To disseminate and exploit results, ME’s are implemented focused on informing, discussing, investigating, sharing and adapting the process and results of the O's. The clinical reasoning framework that will be developed will be the foundation for a clinical reasoning training course to support and enhance clinical reasoning skills in university colleges (nursing/midwifery) and in practice. The framework and training course support educational professionals in inquiring and enhancing clinical reasoning. O’s are presented and optimized using dedicated presentations and discussions with the target groups. Through a conference and course, clinical reasoning will be further spread. The framework and training courses for clinical reasoning remain freely available for ongoing education and to those who are interested in clinical reasoning.O1 operational framework, evidence based combined with practice, on key competencies of clinical reasoning for nursing/midwifes. O1 is the backbone of the project and the foundation to develop O2-O4 and will combine evidence with practical experience on clinical reasoning for nurses/midwifes from the professional’s point of view, with defining, delineating and setting expectations from the learner. Most importantly it will provide an operational framework and explain what registered nursing/midwifes students and registered nurses/midwifes understanding is of clinical reasoning across various EU countries and what is necessary to realize higher levels of clinical reasoning. O1 will describe how nursing/midwifery students and registered nurses/midwifes engage in clinical reasoning across various EU countries describing the process of clinical reasoning in care situations & how we facilitate nurses/midwifes ability to engage in clinical reasoning. It will explain how interdisciplinary health care teams can work on main competencies to realize higher levels of clinical reasoning for nurses/midwifes. Finally O1 will illustrate good practices of narrowing the gap between education and practice, different examples how integrated clinical reasoning can look like in nursing/midwifery education across EU countriesO2 training course in clinical reasoning that includes a set of materials with practical guides to support nurses and nursing/midwife students in key competencies of clinical reasoning within the specific context of their practice. It will focus on teaching how to apply clinical reasoning in daily practice for registered/experienced nurses/midwifes and nursing/midwifery students in nursing/midwife education. It will be an easily accessible course consisting of a theoretical training on the framework of clinical reasoning, why clinical reasoning is so important, how to apply clinical reasoning within an interdisciplinary teams in various settings. Furthermore, it will include the application of clinical reasoning in daily practice by using training based on real-life cases, including practical guides for the target group. Enhancing empathy, clinical leadership and patient safety by applying clinical reasoning will be an important part of the training course.O3 Clinical reasoning nurse/midwife champion training course for nurses/midwife champions who took the training course (O2) with interest and knowledge beyond their peers in the topic of clinical reasoning . The champion training course will play a key role in further bridging the gap between theory and practice. This additional training course is geared towards unit based registered nurses/midwifes will be trained to be champions and create and sustain a clinical reasoning culture on their ward.O4 measuring tool - development of an instrument to measure impact of the clinical reasoning training course. Including a reflection instrument for teams to map their state of play on key competencies of clinical reasoning for nurses/midwifes.<< Results >>We aim to improve clinical reasoning skills of nursing/midwife students and experienced nurses/midwifes by developing a training course in clinical reasoning. This training course will provide opportunities to practice clinical reasoning skills through various real-life situational experiences, thus, to create a safe, continuous, and efficient learning environment for nurses/midwifes. Through this training course adjoining and important skills such as empathy, clinical leadership and awareness for patient safety will be enhanced. An additional but important goal of these training courses are to help to close the gap between experienced nurses/midwifes understanding of clinical reasoning and nursing/midwifes students understanding of clinical reasoning (and consequently care institutions e.g. hospitals, primary care and nursing/midwife education). We aim to increase the awareness of the importance of actively training clinical reasoning skills by developing a train the trainer including champions who will propagate clinical reasoning at a specific workplace in the context of life-long learning. We aim to measure how a training course impacts nurses/midwifes’ competencies in clinical reasoning, their leadership and their ability to be empathic towards the patient in a hospital setting.Research questions:-What are nursing/midwifes students and registered nursing/midwifes understanding of clinical reasoning across various EU countries?-How do nursing/midwifes students and registered nursing/midwifes engage in clinical reasoning across various EU countries-To describe how nursing/midwife students and registered nursing/midwifes engage in clinical reasoning in their daily practice-To describe the process of clinical reasoning in complex care situations-To describe the various teaching models for nursing/midwife students across EU countries-To develop and evaluate a training course for nursing/midwife students and registered nursing/midwifes in clinical reasoning-How do we facilitate nurses/midwifes ability to engage in clinical reasoning?-How does a training course impact nursing/midwifes competency in clinical reasoning, their leadership and their ability to be empathic towards the patient in a hospital setting?OutputO1 operational framework, evidence based combined with practice, on key competencies of clinical reasoning for nursing/midwifes. O2 training course: to develop a training course in clinical reasoning that includes a set of materials with practical guides to support nurses and nursing/midwife students in key competencies of clinical reasoning within the specific context of their practice.O3 Clinical reasoning nurse/midwife champion training course: to develop a training course for nurses/midwife champions, clinical nurses/midwife with interest and knowledge beyond their peers in the topic of clinical reasoning.O4 measuring tool - development of an instrument to measure impact of the clinical reasoning training course. Including a reflection instrument for teams to map their state of play on (key competencies of clinical reasoning) for nurses/midwifes.

Context and background of the project:For a rational use of healthcare technologies, their potential value and impact need to be explored. Health Technology Assessment (HTA) provides a systematic evaluation of the properties and (in)direct effects of healthcare technologies to inform decision making. Currently, HTA involves the assessment of safety, clinical effectiveness and cost-effectiveness, and sometimes ethical, legal, organisational and social issues associated with healthcare technologies. These issues are addressed separately from each other as distinct and potentially relevant aspects that need to be taken into account in determining the value of healthcare technology. A limitation of this approach is that it draws a sharp distinction between empirical inquiry on the one hand, and normative inquiry on the other. Such distinction cannot, however, be sustained. The relevance of empirical inquiry into different aspects of healthcare technologies, such as its safety and effectiveness, is derived from a commitment to certain values (e.g. avoiding harm). At the same time, normative inquiry, for instance asking whether a particular treatment respects a patient’s autonomy, necessarily draws on acquaintance with relevant facts. Hence, a new approach towards HTA is needed, one that allows for integration of empirical analysis and normative inquiry. This approach should help the new generation of HTA practitioners to explain to a wider audience how normative commitments give rise to specific empirical inquiry. By explicitly placing empirical inquiry in the context of normative commitments, the VALIDATE approach also offers a means to involve all relevant stakeholders in HTA in a more structural and effective way, i.e. from the start. For students of HTA, it means that they need to familiarize themselves more deeply with concepts and methods that have been developed in the fields of policy sciences and ethicsThe objectives of the VALIDATE project were to develop a new approach towards HTA which allows for the integration of empirical analysis and normative inquiry, developing associated teaching materials and providing opportunities for internships to apply the approach in HTA practice. To this end, a consensus statement was developed, defining the sort of knowledge and skills that are required to conduct this novel type of integrative HTA. Based on the consensus statement, an e-learning course and handbook were developed to educate HTA practitioners in conducting an integrative HTA. Students who successfully completed the e-learning course were offered the opportunity to practice their newly obtained knowledge and skills in internships. Experiences and learning achievements of students were captured in order to further improve the format and content of the teaching materials.Number and profile of participants:Master students, PhD candidates and young professionals in HTA participated by testing and completing the e-learning course, providing feedback on the handbook, and conducting internship projects offered by the partner institutes. In total, 60 participants from 12 different European countries were enrolled in the e-learning course. Twelve participants, from 4 different European countries, completed an internship project. During workshops and panel sessions at the annual meeting of HTAi, over 500 experts from the HTA community (e.g. students, policy makers, HTA researchers, clinicians, industry and patient representatives) were introduced to VALIDATE.Results and impact:All project objectives have been achieved. A consensus statement was developed and published on the project website. Based on this statement, a completely new e-learning course on integrative HTA has been developed, containing text, videos, intermediate assignments, a discussion board, and a final assignment. The e-learning course is freely available on the project website, and has been reviewed and accredited by HTA international (HTAi), the global professional society of HTA. In addition, a handbook containing eight chapters, addressing different aspects of an integrative approach towards HTA has been written and published on the project website. In total, four scientific papers on the VALIDATE project have been submitted to peer-reviewed journals. Finally, the VALIDATE project has been presented at various international meetings.Longer-term benefits:The project results will remain freely available at the project website. Ultimately, these outputs should result in a shift in people’s thinking about the added value of HTA. This would mean a shift from a strong focus on clinical effectiveness and health economics towards an inquiry that brings more clearly the underlying values into view and that admits for a more constructive role for stakeholders in the process. Clearly, for such a shift to take place, more time and sustained efforts are needed. The VALIDATE consortium is committed to continue making those efforts.

SAFETY is an initiative of 10 partners from 7 European countries (AT, DE, ES, IT, NO, PT, RO) that aims at renovating the educational offer in the field of Emergency Medicine. It will based on the adoption of simulation device, both physical (e.g. mannequin) and virtual patient. Universities and companies developing simulation tools will work together to design a new blended course composed of both theoretical and practical modules. Theoretical module will be delivered as e-learning, while practical module will consist of traditional class during which students will practice with simulation tools. The practical module will be recorded and appended to the e-learning output. Moreover, 2 additional training packages will be developed to address learners when dealing with exceptional situations consisting of situations in which lacks one of the fundamental component of the Emergency team, and when dealing with panicked patient’s relatives.The overall development of the training material will be addressed by relevant psychologist engaged in researches concerning the optimal Emergency team composition. At the end of the project, an Handbook to standardize the procedure to adopt the SAFETY outputs in order to guarantee the project sustainability and result exploitation beyond its lifetime.