Annali dell'Istituto superiore di sanita
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Ann. Ist. Super. Sanita · Jan 2012
ReviewChemicals in the water environment. Where do the real and future threats lie?
There are many potential sources of chemical constituents and contaminants in water that can reach drinking water. Not all substances will be present in any particular water. ⋯ Our knowledge of contaminants in water is, however, incomplete as additional contaminants emerge with advancing analytical methods. Most of these emerging contaminants are present as a consequence of day to day use by the wider human population and control requires a different approach to the substance by substance regulation prevalent at present.
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On the basis of the author's experience as member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and in order to facilitate the access of new orphan drugs to the patients, some suggestions were given. Among these the following should be taken into account by the regulatory bodies: 1) conditional approval or approval under exceptional circumstances should be granted more frequently; 2) the opinion of international societies for rare diseases should be taken into greater account by the EMA Committees; 3) the guidelines requirements should be interpreted more flexibly; 4) in comparison to the fulfilment of primary and secondary endpoints, the improvement of the quality of life should justify the approval of a new orphan drug; 5) the rigidity of guideline requirements should not prevail over the unmet medical need for severe and lethal rare disorders; 6) the statistical values of clinical data to the limit of significance should not prevail over the opinion of patients' associations and international scientific societies; 7) the current legislation should be amended.
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Comparing cancer survival among the European countries is important to evaluate the performance of Health Care Systems and reduce disparities in access to diagnostic and treatment facilities. The EUROCARE project compares survival in Europe since the nineties. The EUROCARE- 4 analysed 2 690 922 adult cancer cases from 83 cancer registries in 22 European countries, diagnosed in 1995-1999, and followed to December 2003. ⋯ For all cancers, five-year survival was very variable also for the different sites mix. Continuing to monitoring cancer survival in Europe is important to reduce differences in access to diagnostic and therapeutic facilities. After publication of EUROCARE results, UK and Denmark developed a National cancer plan to improve time of diagnosis and treatment.