994 resultados para European Medicines Agency


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Independent regulatory agencies are one of the main institutional features of the 'rising regulatory state' in Western Europe. Governments are increasingly willing to abandon their regulatory competencies and to delegate them to specialized institutions that are at least partially beyond their control. This article examines the empirical consistency of one particular explanation of this phenomenon, namely the credibility hypothesis, claiming that governments delegate powers so as to enhance the credibility of their policies. Three observable implications are derived from the general hypothesis, linking credibility and delegation to veto players, complexity and interdependence. An independence index is developed to measure agency independence, which is then used in a multivariate analysis where the impact of credibility concerns on delegation is tested. The analysis relies on an original data set comprising independence scores for thirty-three regulators. Results show that the credibility hypothesis can explain a good deal of the variation in delegation. The economic nature of regulation is a strong determinant of agency independence, but is mediated by national institutions in the form of veto players.

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From 2016, it will be mandatory for most pre-packed food to carry nutrition labelling.  This provides an opportunity to review the provision of additional nutrition labelling that is provided voluntarily on the front of packs.  The Governments across the UK are committed to the provision of nutritional information to help consumers make better informed food choices. Key points from IPH response Obesity and related chronic conditions are already very prevalent and are expected to increase over the next decade, placing greater financial burden on health care services. Helping consumers to make informed choices about their diet is an important aspect of tackling obesity. Providing clear consistent and easy to understand front of pack (FoP) nutrition information is important in helping consumers to make healthy choices. IPH would support FoP nutrition information using the traffic light labelling scheme and High/Medium/Low text. FoP nutrition labelling should be supported by a public information campaign to educate consumers about portion sizes and recommended daily intakes of fat, sugar and salt. IPH would support a nutrition labelling approach which empowers and enables consumers to take responsibility for their own health through informed dietary choices. The FoP traffic light labelling scheme has the potential to encourage healthier product formulation as manufacturers pursue market share. This in turn would contribute to wider availability of healthier products.

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IPH welcomes this European Review conducted by the Marmot Review Team which aims to inform action on social determinants of health and health equity within the forthcoming health policy for the European region, Health 2020. IPH calls for clear mandates supporting whole-of-government approaches to address social determinants and outlines some of the specific challenges and opportunities within the current Ireland and Northern Ireland policy landscape.

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The Health and Social Care Board (HSCB) and the Public Health Agency (PHA) launched a new Community Development Strategy for public consultation.  The HSCB and PHA want to see strong, resilient communities where everyone has good health and wellbeing, places where people look out for each other and have community pride in where they live. The HSCB and PHA seek a number of benefits from implementing this strategy including; a reduction in health and wellbeing inequalities, which also means addressing the social factors that affect health; strengthening partnership working with service users, the community and voluntary sectors and other organisations; strengthening families and communities; supporting volunteering and making best use of our resources. Key points from the IPH summary include IPH welcome the Community Development Strategy as an approach to enhance health and wellbeing and tackle health inequalities in Northern Ireland.   IPH recommend the current three strategy documents (Full and summary versions and the Performance Management Framework) are merged into one document for greater clarity. Reference to the Performance Management Framework is required in the main body of the text is to ensure good practice is implemented. IPH welcome the focus on tackling health inequalities using community development approaches however the contribution of community development approaches needs to be highlighted. HIA is a tool to support community engagement and provides a mechanism for HSCB and PHA to support the implementation of this strategy.

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The Institute of Public Health in Ireland (IPH) promotes co-operation between Northern Ireland and the Republic of Ireland. It aims to improve health by working to combat health inequalities and influence public policies in favour of health. IPH promotes co-operation in research, training, information and policy in order to contribute to policies which tackle inequalities in health. IPH welcomes the Food Standards Agency Strategy for 2010 to 2015 and the opportunity to comment on the publication. We restrict our comments to the “Healthy Eating for All” aspect of FSA’s purpose with particular reference to local development in Northern Ireland.

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The Institute of Public Health in Ireland is an all-island body which aims to improve health in Ireland by working to combat health inequalities and influence public policies in favour of health. The Institute promotes co-operation in research, training, information and policy in order to contribute to policies which tackle inequalities in health. Over the past six years the Institute has worked closely with the Department of Health and Children and the Department of Health, Social Services and Public Safety in Northern Ireland to build capacity for Health Impact Assessment. The Institute takes the view that health is determined by policies, plans and programmes in many sectors outside the health sector as well as being dependent on access to and availability of first class health services. The importance of other sectors is encapsulated in a social determinants of health perspective which recognises that health is largely shaped and influenced by the physical, social, economic and cultural environments in which people live, work and play. Figure 1 illustrates these multi-dimensional impacts on health and also serves to highlight the clear and inextricable links between health and sustainable development. Factors that impact on long-term sustainability will thus also impact on health.

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Phthalates are suspected to be endocrine disruptors. Di(2-ethylhexyl) phthalate (DEHP) is assumed to have low dermal absorption; however, previous in vitro skin permeation studies have shown large permeation differences. Our aims were to determine DEHP permeation parameters and assess extent of skin DEHP metabolism among workers highly exposed to these lipophilic, low volatile substances. Surgically removed skin from patients undergoing abdominoplasty was immediately dermatomed (800 μm) and mounted on flow-through diffusion cells (1.77 cm(2)) operating at 32°C with cell culture media (aqueous solution) as the reservoir liquid. The cells were dosed either with neat DEHP or emulsified in aqueous solution (166 μg/ml). Samples were analysed by HPLC-MS/MS. DEHP permeated human viable skin only as the metabolite MEHP (100%) after 8h of exposure. Human skin was able to further oxidize MEHP to 5-oxo-MEHP. Neat DEHP applied to the skin hardly permeated skin while the aqueous solution readily permeated skin measured in both cases as concentration of MEHP in the receptor liquid. DEHP pass through human skin, detected as MEHP only when emulsified in aqueous solution, and to a far lesser degree when applied neat to the skin. Using results from older in vitro skin permeation studies with non-viable skin may underestimate skin exposures. Our results are in overall agreement with newer phthalate skin permeation studies.

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Mentre que les nanotecnologies s'espera que porti beneficis importants en molts sectors i contribuir a la competitivitat, hi ha un creixent cos de dades científiques que indiquin que hi ha motius raonables per témer que els nanomaterials en particular pot donar lloc a els possibles riscos i efectes nocius per a la salut i el medi ambient. El meu objectiu és examinar com la Unió Europea està donant forma a un règim regulatori per nanomaterials: l'opció regulatòria escollida, la legislació vigent aplicable i la seva eficàcia (amb especial atenció sobre REACH buits normatius), la posició adoptada per la els diferents actors en aquest procés i l'evolució prevista legal en el curt termini.

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Head and neck squamous cell cancer (HNSCC) is the sixth leading cause of cancer-related deaths worldwide. These tumors are commonly diagnosed at advanced stages and mortality rates remain high. Even cured patients suffer the consequences of aggressive treatment that includes surgery, chemotherapy, and radiotherapy. In the past, in clinical trials, HNSCC was considered as a single disease entity. Advances in molecular biology with the development of genomic and proteomic approaches have demonstrated distinct prognostic HNSCC patient subsets beyond those defined by traditional clinical-pathological factors such as tumor subsite and stage [Cho W (ed). An Omics Perspective on Cancer Research. New York/Berlin: Springer 2010]. Validation of these biomarkers in large prospective clinical trials is required before their clinical implementation. To promote this research, the European Organisation for Research and Treatment of Cancer (EORTC) Head and Neck Cancer Program will develop the following strategies-(i) biobanking: prospective tissue collection from uniformly treated patients in the setting of clinical trials; (ii) a group of physicians, physician-scientists, and EORTC Headquarters staff devoted to patient-oriented head and neck cancer research; (iii) a collaboration between the basic scientists of the Translational Research Division interested in head and neck cancer research and the physicians of the Head and Neck Cancer Group; and (iv) funding through the EORTC Grant Program and the Network Core Institutions Consortium. In the present report, we summarize our strategic plans to promote head and neck cancer research within the EORTC framework.

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A Guide to Implementing Nurse and Pharmacist Independent Prescribing within the HPSS in Northern Ireland

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The aim of this paper is to analyse the effects of human capital, advanced manufacturing technologies (AMT), and new work organizational practices on firm productivity, while taking into account the synergies existing between them. This study expands current knowledge in this area in two ways. First, in contrast with previous works, we focus on AMT and not ICT (information and communication technologies). Second, we use a unique employer-employee data set for small firms in a particular area of southern Europe (Catalonia, Spain). Using a small firm data set, allows us to analyse the particular case of small and medium enterprises, since we cannot assume they have the same characteristics as large firms. The results provide evidence in favor of the complementarity hypothesis between human capital, advanced manufacturing technologies, and new work organization practices, although we show that the complementarity effects depend on what type of work organization practices are used by a firm. For small and medium Catalan firms, the only set of work organization practices that improve the benefits of human capital and technology investment are those practices which are more quality oriented, such as quality circles, problem-solving groups or total quality management.

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OBJECTIVES: To assess the impact of neoadjuvant chemoradiotherapy (NCRT) on anastomotic leakage (AL) and other postoperative outcomes after esophageal cancer (EC) resection. BACKGROUND: Conflicting data have emerged from randomized studies regarding the impact of NCRT on AL. METHODS: Among 2944 consecutive patients operated on for EC between 2000 and 2010 in 30 European centers, patients treated by NCRT after surgery (n = 593) were compared with those treated by primary surgery (n = 1487). Multivariable analyses and propensity score matching were used to compensate for the differences in some baseline characteristics. RESULTS: Patients in the NCRT group were younger, with a higher prevalence of male sex, malnutrition, advanced tumor stage, squamous cell carcinoma, and surgery after 2005 when compared with the primary surgery group. Postoperative AL rates were 8.8% versus 10.6% (P = 0.220), and 90-day postoperative mortality and morbidity rates were 9.3% versus 7.2% (P = 0.110) and 33.4% versus 32.1% (P = 0.564), respectively. Pulmonary complication rates did not differ between groups (24.6% vs 22.5%; P = 0.291), whereas chylothorax (2.5% vs 1.2%; P = 0.020), cardiovascular complications (8.6% vs 0.1%; P = 0.037), and thromboembolic events (8.6% vs 6.0%; P = 0.037) were higher in the NCRT group. After propensity score matching, AL rates were 8.8% versus 11.3% (P = 0.228), with more chylothorax (2.5% vs 0.7%; P = 0.030) and trend toward more cardiovascular and thromboembolic events in the NCRT group (P = 0.069). Predictors of AL were high American Society of Anesthesiologists scores, supracarinal tumoral location, and cervical anastomosis, but not NCRT. CONCLUSIONS: Neoadjuvant chemoradiotherapy does not have an impact on the AL rate after EC resection (NCT 01927016).