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University of Bristol 4 th May 2011

University of Bristol 4 th May 2011. Agenda. MRC’s role within FP7 Funding opportunities within FP7 2012 Health Work Programme Key points Topics by activity area. MRC and FP7. MRC has four roles in FP7: Participant NCP for the Health Theme – Victoria Brewer

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University of Bristol 4 th May 2011

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  1. University of Bristol 4th May 2011

  2. Agenda • MRC’s role within FP7 • Funding opportunities within FP7 • 2012 Health Work Programme • Key points • Topics by activity area

  3. MRC and FP7 MRC has four roles in FP7: • Participant • NCP for the Health Theme – Victoria Brewer • Programme Management Committee (Health) – Mark Palmer • State Representative for Innovative Medicines Initiative – Jill Jones • MRC leads the PMC delegation at the invitation of the Department of Business Innovation and Skills (BIS) • Alternative delegates are: • Department of Health (DH) • Technology Strategy Board • Expert group e.g. UKRO • Joint lead between MRC and BIS

  4. What is FP7 • Main mechanism used by the European Commission to fund research across Europe. • Two main aims: • To strengthen the scientific and technological base of European industry. • To encourage international competitiveness while promoting research that supports EU policies. • How does the EC aim to achieve this? • Pooling resources • Integration of research • Excellence in research • Addressing Specific Needs • Addressing Pan-European challenges • Coordinating national and regional programmes • Conducting comparative research at EU level • Disseminating research result more widely • Assembling critical mass • Enabling “big science” • Leverage private investment • Orphan research • Supporting research careers and mobility of research • Creating world class centres of excellence • EU level competition to increase quality and creativity

  5. FP7 Budget • Seven year funding programme with a budget of around €50.5 Billion To date the UK has received 14% of the overall funding awarded

  6. Ideas – European Research Council • € 7.5bn budget • Managed through the European Research Council (ERC) • Bottom up/investigator led research • Research within your own team – no international collaboration • ERC Early grants • Funding: ~ € 1.5 M for up to 5 year • 2-12 years post PhD at application • UK has received 180* grants to date • ERC-2010-StG call -79/427 went to UK HEI (19%) • ERC Advanced Grants • Funding: ~ € 2.5 M for up to 5 year • “exceptional” research leader • UK has received 172* grants to date • ERC-2010-AdG call - 53/266 went to UK HEI (20%)

  7. People – Marie Curie Actions • €4.75bn budget • Managed through Marie Curie Actions • Research mobility and career development scheme –inc’ • coordination of PhD programmes • Allows for European and International exchange • Schemes for individuals or organisations • To date €1.3 billion awarded • UK share €300.8 million = 23% • Organisation • Initial Training Networks (ITNs) – aimed at initial training of researchers, first five years of researchers' careers. Projects will be based around a Joint Training Programme focussing on scientific and technological knowledge, as well as other complementary skills such as IPR, research management, entrepreneurship • Co-funding of Regional, National and International Programmes (COFUND) - encourage existing or new regional or national programmes to open up and provide for trans-national mobility, as well as to reinforce international programmes. • Individual • Marie Curie Intra-European Fellowships for CareerDevelopment (IEF) -move from one EU or FP7 associated country to another for a duration of 1-2 years. • Marie Curie International Incoming Fellowships (IIF) – bring researchers based outside Europe into an EU Member State or country associated to FP7 for a duration of 1-2 years.

  8. Cooperation • € 32.4bn budget • Top-down research • EC sets the Research Agenda • Proposals must be topic specific • Multiple-disciplinary • Collaborative research • MUST beworking with European Partners • (or Associated Countries/ target specific countries) • 3is a magic number • SICA – 2x MS/AC & 2x target region(s)

  9. Who is eligible to participate? • EU-27 – Member States (MS) Austria, Belgium, Bulgaria , Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Ireland, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK • Associated Countries (AC) Albania*, Bosnia and Herzegovina *, Croatia*, Faroe Islands*, FYR, Macedonia*, Iceland*, Israel*, Liechtenstein*, Montenegro*, Norway*, Serbia*, Switzerland, Turkey* *except Euratom

  10. Third countries: ICPC

  11. What organisation can participate? • Participation is open to a wide range of organisations and individuals: • research groups at universities or research institutes • small or medium-sized enterprises (SMEs) • SME associations or groupings • public or governmental administration (local, regional or national) • organisations and researchers from third countries • international organisations • civil society organisations • Need to register your organisation with the EC

  12. Cooperation Obesity, allergies, zoonoses and systems biology Medication information technologies, activities on ageing, patient safety and virtual physiological human being Biomaterials for health application, nanomedicines and nanotoxicology Environment and Health

  13. 2012 Health Work Programme Research priorities • Active & Healthy Ageing • Europe 2020 - Innovation Union  The pilot European Innovation Partnership on active and healthy ageing • 5 topics each looking to fund more than 1 proposal, 4x €6m and 1x €12m • Medical technologies • Supporting the “innovation" strategy and reduce the time to market • 7 topics each looking to fund more than 1 proposal, 6x €6m and 1x €3m • Rare diseases • Build critical mass for research on rare diseases • Currently 4 topics and 1 HIP but likely to become 7 topics • Clinical Trials • Continue on initiative started in 2011 work programme • Improve the quality of clinical trial data in Europe • 1x Active and Healthy ageing, 2x Rare diseases and 1xDiabetes (type 1)

  14. 2012 Health Work Programme Key features to look out for.. • Strong SME focus in the majority of call topics: • SME-targeted  ≥ 30% budget • SME-focus  ≥ 15% budget • Majority of call are 2 stage (exceptions CSA and ERA Net) Process • Outline submission • Invitation to second stage • Full proposal submission • Results • 2011 WP Deadline • 13th Oct 2010 • ~ 20th Dec 2010 • 10th Feb 2011 • ~ end April/early May 2011

  15. DRAFT Refer to the final published version when released 2012 Health Work Programme CLOSED AREAS: • BIOTECHNOLOGY, GENERIC TOOLS AND MEDICAL TECHNOLOGIES FOR HUMAN HEALTH • 1.1 High-throughput research • 1.3 Suitability, safety, efficacy of therapies 2. TRANSLATING RESEARCH FOR HUMAN HEALTH • 2.2.1 Brain and brain-related diseases • 2.3.1 Anti-microbial drug resistance • 2.3.3 Potentially new and re-emerging epidemics • 2.3.4 Neglected infectious diseases • 2.4.1 Cancer • 2.4.2 Cardiovascular diseases 3. OPTIMISING THE DELIVERY OF HEALTHCARE TO EUROPEAN CITIZENS • 3.1 Translating the results of clinical research outcome into clinical practice including better use of medicines, and appropriate use of behavioural and organisational interventions and new health therapies and technologies • 3.3 Health promotion and prevention 4. OTHER ACTIONS ACROSS THE HEALTHTHEME • 4.2 Responding to EU policy needs

  16. The Health Theme 1 Biotechnology, generic tools and medical technologies for human health 2 Translating research for human health 3 Optimising the delivery of healthcare to European citizens 4 Emerging policy needs/unforeseen needs

  17. ≥ 30 % 1.2 DETECTION, DIAGNOSIS AND MONITORING • HEALTH.2012.1.2-1. Development of technologies with a view to patient group stratification for personalised medicine applications. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Research and development of technologies  application of tailored medical intervention in specifically defined patient group • Proof of principle highlighted • Emphasis of data collection and analysis i.e. statistical tool + quality control around this • Active inclusion of end users (particular for proof of principle)

  18. 1.3 SUITABILITY, SAFETY, EFFICACY OF THERAPIES Innovative Medicines Initiative • Joint EC and EFPIA funding scheme = €2 billion • Research areas in • Safety • Efficacy • Education & training • Knowledge management • 4th call Estimated launched in June 2011 • Indicative topics: • Assessment of drug-induced toxicity in relevant organs – surrogates for early drug failure • Enhancing translation in neurological diseases • European Medical Information Systems • Stem Cells for drug development and toxicity screening • Beyond high-throughput screening • Disease heterogeneity/taxonomy of disease • Genetic mapping of extreme phenotypes • Combination therapy development

  19. 1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS Focus = Transplantation Rationale: • Clinical demand • Continuity of successful FP6 projects • Recent progress in other areas • Policy developments i.e. DG SANCO

  20. ≥ 15 % 1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS • HEALTH.2012.1.4-1: Innovative approaches to solid organ transplantation. Key points: • SME-focused Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Improve the outcome, increase efficiency &/or widen the scope of solid transplantation • Clinical focus inc’. Regulatory, safety & immunological aspects • Improved treatment  improved personal targeting & tolerance

  21. ≥ 30 % 1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS • HEALTH.2012.1.4-2: Medical technology for the transplantation sector and bioartificial organs Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Develop novel tools, techniques & devices for use in transplantation and in bioartifical organs • Include cells, tissues or organs • Clinical/in-patient trial = central to the proposal • Cover safety & efficacy assessment + regulatory work

  22. ≥ 15 % EU & Australia 1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS • HEALTH.2012.1.4-3: Innovative strategies for translation of stem cell based therapies in regenerative medicine. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call • EU and Australia Cooperation • Australian Partners ~ 50% work carried out in Australia • Joint submission to EC and NHMRC • Australian Partners apply to NHMRC ≠ request EU funds  €6m max EC contribution to European Team • Max NHMRC contribution = €6m

  23. 1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS • HEALTH.2012.1.4-2 cont’. Focus: • Characterisation • Mechanisms of action and nature of host response(s) • Quality control of product(s), • Efficacy and safety in relevant preclinical models • Bridging studies can be included • 2 phase project  2nd stage dependent on regulatory approval • 5 year – review at Yr 3  Yrs 4&5 dependent on approval of joint regulatory filing • funds divided equally between the 2 phases • Outcome = Therapeutic products & clinical protocols developed with industrial partners

  24. ≥ 30 % 1.4 INNOVATIVE THERAPEUTIC APPROACHES AND INTERVENTIONS • HEALTH.2012.1.4-4: Targeted nucleic acid delivery as an innovative therapeutic or prophylactic approach. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Immunotherapy, gene therapy or DNA vaccination, RNA interference • Clinical testing carried out throughout of the life time of the project – inc’. regulatory work • Preclinical work around safety, immunogenicity, toxicity and feasibility studies should have already been completed

  25. The Health Theme 1 Biotechnology, generic tools and medical technologies for human health 2 Translating research for human health 3 Optimising the delivery of healthcare to European citizens 4 Emerging policy needs/unforeseen needs

  26. 2.1 INTEGRATING BIOLOGICAL DATA AND PROCESSES: LARGE-SCALE DATA GATHERING,SYSTEMS BIOLOGY 2.1.1 Large-scale data gathering • HEALTH.2012.2.1.1-1: Clinical utility of -omics for better diagnosis and treatment of rare diseases. Key points: • WAS a High Impact Project – going to broken down into individual Collaborative Project Focus: • New topics = Still TBC • Likely to cover • -omics approaches and technologies for molecular characterisation for a chosen rare disease  new diagnostics and treatment in clinical settings • Utilisation of existing databases/biobanks • Coordination and harmonisation of patient registries

  27. ≥ 30 % 2.1.1 Large-scale data gathering (cont’.) • HEALTH.2012.2.1.1-2: Validation of -omics-based biomarkers for diseases affecting the elderly. Key points: • SME-targeted Collaborative Project up to €12m • One or more proposals can be selected. • Two-stage call Focus: • Clinical validation already identified -omics based biomarkers  sensitivity, specificity and predictive power  improved diagnosis, prognosis, patient stratification and/or treatment monitoring • Inc’. statistical models and quality control for data generated

  28. ≥ 15 % 2.1.1 Large-scale data gathering (cont’.) • HEALTH.2012.2.1.1-3: Statistical methods for collection and analysis of -omics data. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Improve or develop new statistical models / tools for analysis of –omic based data • Open to any –omics based data e.g. genomics, proteomics etc or particular class of analysis • Clinical trials excluded • Must include appropriate training and dissemination activities

  29. ≥ 30 % 2.1 INTEGRATING BIOLOGICAL DATA AND PROCESSES: LARGE-SCALE DATA GATHERING,SYSTEMS BIOLOGY 2.1.2 Systems biology • HEALTH.2012.2.1.2-1: Systems medicine: SME-driven research applying systems biology approaches to address medical and clinical needs. Key points: • SME-targeted Collaborative Project up to €3m • One or more proposals can be selected. • Two-stage call • Small to minimum consortium sizes • Project duration up to 2 years • No intermediate payments or reports

  30. 2.1.2 Systems biology (cont’.) • HEALTH.2012.2.1.2-1 cont’. Focus: • Development, improvement and application of systems biology approaches to medical/clinical questions e.g.: • Re-design of clinical trials by shortening timescale and costs; • Development of combinatorial therapies and/or chronotherapies for complex diseases • Development of combinatorial biomarkers • Etc… • Establish proof-of-concept  demonstrate the potential for exploitation • Exploitation of results in clinical an/ or industrial sectors

  31. 2.1.2 Systems biology (cont’.) • HEALTH.2012.2.1.2-2: Systems medicine: Applying systems biology approaches for understanding complex human diseases and their co-morbidities. Key points: • Collaborative Project up to €12m • One or more proposals can be selected. • Two-stage call Focus: • Integrated multidisciplinary research inc’. pre-clinical and clinical research  clinicians, biologists computational scientists, mathematician etc • Address a clear clinical need  new avenues of understanding patho-physiology, diagnosis and treatment of complex diseases

  32. http://ec.europa.eu/research/health/past-events_en.html 2.1.2 Systems biology (cont’.) • HEALTH.2012.2.1.2-3: Preparing for the future research and innovation activities in systems medicine. Key points: • Coordination and Support Action (CAS) up to €3m • Only one proposals can be selected. • Two-stage call Focus: • Promote, support and coordinate research activities in systems biology across Europe • Best practice, information and resources of successful methodological approaches. • Multidisciplinary training requirements for the next generation • Promote innovation activities  technology transfer exploitation

  33. 2.2 RESEARCH ON THE BRAIN AND RELATED DISEASES, HUMAN DEVELOPMENT AND AGEING 2.2.2 Human development and ageing = Primary focus Rationale: • Europe has highest proportion of older people in the world • Grand challenge of understanding the ageing process • More targeted geriatric medicines • Innovation Union partnership – Active and Healthy Ageing http://ec.europa.eu/research/innovation-union/index_en.cfm?section=active-healthy-ageing

  34. ≥ 30 % 2.2.2 Human development and ageing • HEALTH.2012.2.2.2-1: Integrative systems biology and comparative genomics for studying human ageing and/or most common age-related diseases. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Interactions between genetics, epigenetic and environmental factors  ageing phenotype in normal and disease conditions • Computational approaches, comparative genomic studies of existing data and appropriate modelling • Can include tools for diagnosis, prognosis and monitoring of therapies

  35. ≥ 15 % 2.2.2 Human development and ageing (cont’.) • HEALTH.2012.2.2.2.-2: Investigator-driven clinical trials for optimisation of management of elderly patients with multiple diseases. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Compare various treatment regimens in elderly population treated for multiple diseases • Clinical trials looking at efficacy and adverse effects of multi treatment of common age related diseases

  36. ≥ 30 % 2.3 TRANSLATIONAL RESEARCH IN MAJOR INFECTIOUS DISEASES: TO CONFRONT MAJOR THREATS TO PUBLIC HEALTH 2.3.0 Cross-cutting • HEALTH.2012.2.3.0-1: Diagnostics for infectious diseases. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call • No prescribed duration i.e. can be as short as 1-2 years Focus: • Development and/or validation of diagnostic tests for major infectious diseases to meet clinical need • Priority to diseases with unmet medical need i.e. no tests available & improved testing  better control and management

  37. 2.3 TRANSLATIONAL RESEARCH IN MAJOR INFECTIOUS DISEASES: TO CONFRONT MAJOR THREATS TO PUBLIC HEALTH 2.3.2 HIV/AIDS, malaria and tuberculosis • HEALTH.2012.2.3.2-1: Co-infection of HIV/AIDS, malaria, tuberculosis and/or hepatitis. Key points: • Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Basic, translation and/or clinical research • prevention, therapeutic management and prognosis of co-infected patients • Immunological mechanisms and response to co-infection • Priority to co-morbidity of relevance to LMIC

  38. 2.3.2 HIV/AIDS, malaria and tuberculosis(cont’.) • HEALTH.2012.2.3.2-2: Co-morbidity between infectious and non-communicable diseases. Key points: • Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Basic, translation and/or clinical research • prevention, therapeutic management and prognosis of patients infectious and non-communicable diseases • Proposals should address: • Causative links between infectious and non-infectious diseases • Combination of 3 major poverty related diseases (AIDS, malaria or TB) or any major poverty related diseases with non-infectious diseases

  39. ≥ 15 % 2.3.2 HIV/AIDS, malaria and tuberculosis(cont’.) • HEALTH.2012.2.3.2-3: Prevention and treatment for HIV/AIDS, malaria and tuberculosis. Key points: • SME-targeted collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call • No prescribed duration i.e. can be as short as 1-2 years Focus: • Basic or translation research addressing current gaps in • Prevention and/or treatment of poverty related diseases (HIV/AIDS, malaria or TB) • Proposal must inc’: • Detailed plan for exploitation of end results • Explore synergies with relevant EU funded initiatives e.g. European and Developing Countries Clinical Trial Partnership (EDCTP)

  40. 2.3.2 HIV/AIDS, malaria and tuberculosis(cont’.) • HEALTH.2012.2.3.2-4: Low-cost interventions for disease control in resource poor settings. Key points: • Collaborative Project up to €3m • One or more proposals can be selected. • Two-stage call Focus: • Innovative ways to control neglected infectious diseases and/or malaria  low-cost interventions – immediate impact • Novel applications of current tools and knowledge  new cost-effective solutions • Combinational therapy, treatment strategies, epidemiology, access to diagnostics and drugs, operational and implementation research • Inclusion of partners from disease-endemic countries

  41. ≥ 30 % 2.4 TRANSLATIONAL RESEARCH IN OTHERMAJOR DISEASES 2.4.3 Diabetes and obesity • HEALTH.2012.2.4.3-1: Innovative approach to manage diabetes. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Management of diabetes in pre-and/or clinical settings by validating therapeutic devices or biological therapies • Attention to safety, bio-compatibility, interoperability and regulatory aspects  fast and safe uptake of approaches/technologies

  42. 2.4.3 Diabetes and obesity (cont’.) • HEALTH.2012.2.4.3-2: Investigator-driven clinical trials for type 1 diabetes research. Key points: • Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Clinical Trial on type 1 diabetes with focus on paediatric population  improve glycolic control and/or reduce diabetes complications • Inform clinical management of type 1 diabetes • Excludes pilot studies and systematic reviews

  43. ≥ 30 % 2.4 TRANSLATIONAL RESEARCH IN OTHERMAJOR DISEASES 2.4.4 Rare diseases (= < 5/10,000) • HEALTH.2012.2.4.4-1: Preclinical and/or clinical development of substances with a clear potential as orphan drugs. Key points: • Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • MUST be EU designated orphan medicinal products • http://ec.europa.eu/health/documents/community-register/html/orphreg.htm • Preclinical studies in models and/or clinical studies • Excludes cancer and diseases of the nervous system

  44. 2.4.4 Rare diseases (cont’.) • HEALTH.2012.2.4.4-2: Observational trials in rare diseases. Key points: • Collaborative Project up to €3m • One or more proposals can be selected. • Two-stage call Focus: • Rare diseases with no orphan drug available – treated off-label • Improve clinical management of rare diseases  evidence based clinical guidance • Data collection and comparing outcomes of various treatment regimens • Evaluation of effectiveness and adverse events • Excludes cancer, infectious diseases and diseases of the nervous system

  45. 2.4.4 Rare diseases (cont’.) • HEALTH.2012.2.4.4-3: Best practice and knowledge sharing in the clinical management of rare diseases. Key points: • Coordination and Support Action (CAS) up to €2m • Only one proposals can be selected. • Two-stage call Focus: • Development of a networking platform supporting the collection of standardised & validated data and exchange of information providing evidence of best clinical management of rare diseases • Identify additional research needs • Any group of rare diseases

  46. ≥ 30 % 2.4 TRANSLATIONAL RESEARCH IN OTHERMAJOR DISEASES 2.4.5 Other chronic diseases • HEALTH.2012.2.4.5-1: Technological approaches to combating sensory impairments. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Preclinical and clinical testing of novel tools, devices or therapies' for overcoming sensory disability • Prevention and treatment strategies, technological approaches, biological cell based therapies inc’. Stem cells and development of bio-artificial organs

  47. ≥ 15 % 2.4.5 Other chronic diseases (cont’.) • HEALTH.2012.2.4.5-2: Biomarkers and diagnostics for chronic inflammatory diseases of the joints and/or digestive system. Key points: • SME-targeted Collaborative Project up to €6m • One or more proposals can be selected. • Two-stage call Focus: • Development of improved/novel methodologies  early diagnosis of chronic inflammatory diseases • Indicative markers for inflammatory onset and development & evaluation of intervention therapies

  48. The Health Theme 1 Biotechnology, generic tools and medical technologies for human health 2 Translating research for human health 3 Optimising the delivery of healthcare to European citizens 4 Emerging policy needs/unforeseen needs

  49. 3.2 QUALITY, EFFICIENCY AND SOLIDARITYOF HEALTHCARE SYSTEMS INCLUDING TRANSITIONAL HEALTH SYSTEMS • HEALTH.2012.3.2-1: Improving the organisation of health service delivery. Key points: • Collaborative Project up to €3m • One or more proposals can be selected. • Two-stage call • ~ 4 year duration Focus: • Best practice for European health care organisations around, structure, care processes and performance • Areas to be addressed (either one or many): • integration of patient care • Patient centred care and involvement • Skill mix and management of resources (only 1 proposal) • Transfer of knowledge into practice ~ span 5 years

  50. http://www.eunethta.net/ 3.2 QUALITY, EFFICIENCY AND SOLIDARITYOF HEALTHCARE SYSTEMS INCLUDING TRANSITIONAL HEALTH SYSTEMS • HEALTH.2012.3.2-2: New methodologies for health technology assessment. Key points: • Collaborative Project up to €3m • One or more proposals can be selected. • Two-stage call Focus: • Develop new and/or improved methodologies for Health Technology Assessment (HTA) • Areas of focus (either or both): • Methodologies for addressing the complexity of interventions • Methodologies to assess the efficacy and effectiveness of technologies • Complement previously funded work i.e. EUnetHTA JA

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