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LONDON, United Kingdom

Agency: Cordis | Branch: FP7 | Program: CSA-SA | Phase: SiS.2012.1.2-1 | Award Amount: 3.78M | Year: 2013

This project aims to contribute to the introduction of Responsible Research and Innovation in neuro-enhancement (NE) in the European Research Area and to the shaping of a normative framework underpinning the governance of NE technologies. These will be achieved through mobilization and mutual learning (MML) activities engaging scientists, policy-makers, industry, civil society groups and the wider public. To structure this complex socio-technical domain we propose Analytic Classification of NE technologies into currently available methods, experimental and hypothetical technologies. Each of the types raises some fundamental ethical, legal, social and economic issues, which have different relevance to various societal groups point to different methods of stakeholder engagement, and require different regulatory approaches. Over the course of the project the Analytic Classification will be developed and extended in the work packages. Mobilization will form the central commitment of the project from the outset to the conclusion. WP2 starts with a reconnaissance of the field of NE and the mobilisation of scientists and other stakeholders. Based on the Analytic Classification WP3 will stimulate and organize a broad societal dialogue employing state-of-the-art engagement methodologies tailored to specific issues and stakeholders. A particular focus will be the hopes, fears and expectations of the wider public. WP4 will synthesise the national experiences, map the contours of a normative framework as it emerges from societal engagement and dialogue and elaborate the concept of RRI in Europe. WP5 aims through a variety of dissemination strategies to maximise the impact of the project outcomes throughout Europe. The consortium comprises experts in the neurocognitive sciences, the social sciences and humanities and science communication. Many have prior experience of EC projects and of successful collaborations with other members of the consortium.

Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2011.4.2-1 | Award Amount: 5.52M | Year: 2011

The aim of TAIN is to develop a neonatal formulation of hydrocortisone, a drug included in the EMA priority list that needs specific evaluation in the age range 0 2 years (neonates & infants). Hydrocortisone is an essential glucocorticoid hormone used as replacement therapy for the treatment of congenital and acquired adrenal insufficiency as well playing an important therapeutic role in oncology in infants, specifically brain tumours and leukaemias. TAIN involves European leaders in neonatology, paediatric pharmacology, methodology and SMEs that will establish links with ethical bodies and regulatory authorities. The programme will perform in silico experiments and evaluate formulations for neonates. The phase 3 clinical trial comparing the neonatal hydrocortisone versus current (unlicensed) therapy will be optimized using age-appropriate state-of-the-art methods adapted to neonates (including in silico experiments and pharmacokinetics) to validate the components of a Paediatric Investigation Plan. It will be performed by neonatologists trained in paediatric pharmacology and clinical research in line with guidelines on Good Clinical Practice. All the ethical issues will be considered, including pain and distress, blood sampling (number and volume) and informed consent. Parent information sheets and consent form will be submitted to patient and parents associations for approval. TAIN will include short term safety studies and Phase 3 clinical studies in neonates and infants. Results will be reported in order to allow a PUMA application to be submitted and to improve neonatal and infant care. Therefore, TAIN will validate the appropriate use of hydrocortisone in neonates and infants which will be of direct benefit to children, their families and health professionals. TAIN will strengthen paediatric drug evaluation across Europe and build up a network of units with experience in clinical research that will be used for additional drug evaluation in neonates.

Agency: Cordis | Branch: FP7 | Program: CSA-CA | Phase: HEALTH.2010.1.2-3 | Award Amount: 2.25M | Year: 2011

EuroGentest is an FP6 European network for the harmonization of genetic testing and for the further improvement of quality in genetic services across Europe. This proposal is to support EuroGentest2, a Coordination Action that will cover the different aspects of quality assurance of genetic practice and has all the ingredients to fulfil the needs. EuroGentest2 will be concerned with setting the targets for laboratory and health professional accreditation, by contributing to guidelines and standards, and actively interacting with the professional organizations and the policy makers. EuroGentest2 will also assist the diagnostic and clinical community and the individual laboratories and counselling units in reaching those aims by providing tools for quality management and by coordinating training activities. EuroGentest2 will extend its activities from postnatal diagnostic and predictive testing to prenatal testing, thereby building on the achievements of the FP6 SAFE network, and to direct to consumer testing. A major aim of the Coordination Action will be the creation of a European association of genetic diagnostic centres that will guarantee the future of the network. The Coordination Action will lead to the further harmonization and quality assurance of genetic practice. The patients will benefit by the improvement of the analytical and clinical quality and validity of the testing, and from improved trans-border services and information. The European diagnostics industry will benefit through a faster access of innovations to the market through the validation for diagnostic use. It will enable countries and regions with less developed health care infrastructure to develop standards for best practice of provision of clinical genetic service. The Coordination Action will also identify research needs and have the capacity to set a research agenda that corresponds to the needs of the human genetics community

Agency: Cordis | Branch: FP7 | Program: CSA-CA | Phase: HEALTH-2007-4.1-4 | Award Amount: 1.01M | Year: 2008

The aim of this 3-year Coordination Action will be to identify the patients needs for partnership in the clinical trials context. Moreover, this project will lead to both a well-organized and sustainable communication platform and guidelines to enable the mutual beneficial interactions between patients and clinical trials professionals. This aim will be realized through: I) Interviews, addressing patients (-organizations) that will identify preliminary needs in the clinical trials context from a patients perspective. These data are complemented with literature reviews and descriptions of best practices. The combined outcomes will be accessable on a centralized webbased database. II) Subsequent workshops addressing patients (and patient organizations), researchers and scientists, biopharmaceutical companies, regulators and other stakeholders in the clinical trials context. In these workshops, the conclusions from the interviews, literature studies and best practices will be challenged to draw European viewpoints and consensus. On the specific website, attendees will be able to consult the outcomes from both the investigational phase and previous workshops. III) The establishment of the European Network of Patients partnering for Clinical Research (EN-PCR). Initially, EN-PCR will be responsible for addressing the high priority issues in this project: paediatric clinical trials, patient registries and biobanks, the Innovative Medicines Initiative (IMI) and ethical issues. Later on, EN-PCR will guarantee the sustainability of this project, being a permanent structure with a bi-directional purpose, both empowering patients and functioning as a one-stop shop for academic and biopharmaceutical research. IV) Further dissemination of the project results will be achieved by a Patient Guide for patient organizations, an Investigator Guide for organizers and sponsors of clinical trials, a List of Recommendations for regulators and a thematic website. The consortium will provide continued support to both EN-PCR and the PatientPartner website after this Coordination Action has ended. This project is implemented by key European and national patient network organisations, and a forum for Good Clinical Practice. It concurrently supports patient-centered clinical research and European biophamaceutical competiveness.

Agency: Cordis | Branch: FP7 | Program: CSA-SA | Phase: NMP-2007-1.2-2 | Award Amount: 784.58K | Year: 2009

The fundamental objective of this Round Table exercise is to respond substantially to the need for genuine engagement and involvement of all the key stakeholders (public and private) in the nanomedical field in preparing the groundwork for optimised and collective decision-making at the European level. Although very promising, nanomedicine may add new dimensions to many ethical, social and economic issues. It is of primary importance to understand its possible impacts and provide for stakeholders a well-organised forum. The Round Table will bring together representatives from the nanomedical sciences and technologies involved, industry, patient groups, regulatory bodies, health insurance and policy making, and experts on the ethical, regulatory, social, economic and public engagement and communication and issues. The goal will be to: - collect the most relevant information to be discussed of: - actual achievements and, separately, promises of nanomedical innovation - recommendations issued by the European Commission, Member States and exercises carried out by various national and international bodies - present these in a user-friendly format appropriate for each of the main stakeholder groups with questions to be discussed - carry out a consensual debate concluding with agreed recommendations between various positions The Round Table will have important impacts by: - establishing a clear set of recommendations to support decision making at the European level - identifying priority areas for research and development and for societal actions - significantly enhancing the flow of knowledge reciprocally between each of the key stakeholder groups along the chain from research to patient - helping to reduce fragmentation in nanomedical research across Europe - contributing to mobilising additional public and private investment in nanomedical R&D in Europe - and overall thereby stimulating innovation in nanobiotechnologies for medical use

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