Do public inquiries for noise control serve a useful purpose?--An acoustic consultant's view.
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In the United Kingdom, before the introduction of the various town and country planning acts and associated regulations, landowners were free to use their land in any way they wished, subject only to limitations imposed by lease or covenant and the avoidance of nuisance or trespass against neighbours. Any disputes arising would be resolved by negotiation or via a court of law. Under current planning laws and regulations, local authorities are empowered to impose special conditions or even to refuse development to prevent excessive nuisance, but the resulting noise management solutions are not always optimum from either the noise maker's or the noise exposed's points of view. In addition, the planning system has almost no effect on existing noise. Public inquiries provide a useful mechanism for the investigation of appeals against local authority decisions, or where the government has decided that issues of strategic or national importance need to be fully explored in a public forum. In practice, and largely because of individual disagreement, public inquiries can result in excessive delays while all interested parties are allowed to have their say. There seems to be an increasing consensus that the general inadequacy of existing methods of assessing noise impact is at least partly to blame. The new European Environmental Noise Directive represents a step change towards the imposition of one-size-fits-all regulatory or administrative procedures which should eventually contribute towards the reduction of public inquiry delays, but on the other hand, any weakening of the general principle of basing decisions on 'informed flexibility' will probably have significant negative consequences over the longer term. (+info)
European Board of Orthodontists: a professional challenge.
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The background to the formation of the European Board is given and the necessary procedures for obtaining certification of the European Board of Orthodontists (EBO) are described. An example case report is included to give the reader an indication of the type of detail required for each and every case presented. Recommendations are given for prospective candidates who might consider attempting EBO certification in the future. (+info)
International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice.
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M2 eCTD: Electronic Common Technical Document Specification." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. The guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority. (+info)
Harmonization of pulsed-field gel electrophoresis protocols for epidemiological typing of strains of methicillin-resistant Staphylococcus aureus: a single approach developed by consensus in 10 European laboratories and its application for tracing the spread of related strains.
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Pulsed-fieldgel electrophoresis (PFGE) is the most common genotypic method used in reference and clinical laboratories for typing methicillin-resistant Staphylococcus aureus (MRSA). Many different protocols have been developed in laboratories that have extensive experience with the technique and have established national databases. However, the comparabilities of the different European PFGE protocols for MRSA and of the various national MRSA clones themselves had not been addressed until now. This multinational European Union (EU) project has established for the first time a European database of representative epidemic MRSA (EMRSA) strains and has compared them by using a new "harmonized" PFGE protocol developed by a consensus approach that has demonstrated sufficient reproducibility to allow the successful comparison of pulsed-field gels between laboratories and the tracking of strains around the EU. In-house protocols from 10 laboratories in eight European countries were compared by each center with a "gold standard" or initial harmonized protocol in which many of the parameters had been standardized. The group found that it was not important to standardize some elements of the protocol, such as the type of agarose, DNA block preparation, and plug digestion. Other elements were shown to be critical, namely, a standard gel volume and concentration of agarose, the DNA concentration in the plug, the ionic strength and volume of running buffer used, the running temperature, the voltage, and the switching times of electrophoresis. A new harmonized protocol was agreed on, further modified in a pilot study in two laboratories, and finally tested by all others. Seven laboratories' gels were found to be of sufficiently good quality to allow comparison of the strains by using a computer software program, while two gels could not be analyzed because of inadequate destaining and DNA overloading. Good-quality gels and inclusion of an internal quality control strain are essential before attempting intercenter PFGE comparisons. A number of clonally related strains have been shown to be present in multiple countries throughout Europe. The well-known Iberian clone has been demonstrated in Belgium, Finland, France, Germany, and Spain (and from the wider HARMONY collection in Portugal, Slovenia, and Sweden). Strains from the United Kingdom (EMRSA-15 and -16) have been identified in several othercountries, and other clonally related strains have also been identified. This highlights the need for closer international collaboration to monitor the spread of current epidemic strains as well as the emergence of new ones. (+info)
Distribution and determinants of sedentary lifestyles in the European Union.
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BACKGROUND: Many studies have shown the health burden of a sedentary lifestyle. The main goal of this study was to determine the prevalence of sedentary lifestyles in the 15 Member States of the European Union (EU) and to identify the main correlates of a sedentary lifestyle. METHODS: Nationally representative samples (n approximately 1000 subjects in each country; >15 years) completed a questionnaire concerning attitudes to physical activity, body weight, and health; in total 15 239 subjects. Sedentary people were defined in two ways: (1) those expending less than 10% of their leisure time expenditure in activities involving >/=4 metabolic equivalents (MET). (2) Those who did not practice any leisure-time physical activity and who also were above the median in the number of hours spent sitting down during leisure time. Logistic regression models were fitted to analyse the association between sedentary lifestyles and gender, age, body mass index (BMI), educational level, weight change in the last 6 months, and marital and smoking status. RESULTS: Percentages of sedentary lifestyles across European countries ranged between 43.3% (Sweden) and 87.8% (Portugal) according to the first definition. According to both definitions, a lower prevalence of sedentary lifestyle was found in Northern countries (especially Scandinavian countries) as compared with Mediterranean countries, whereas the prevalence was higher among older, obese, less educated, widowed/divorced individuals, and current smokers. Similar relative differences between countries and socio-demographic groups were found independently of the method used to define a sedentary lifestyle. CONCLUSION: Prevalence of sedentary lifestyle in the EU is high, especially among inhabitants of some Mediterranean countries, obese subjects, less-educated people, and current smokers. This high prevalence involves important public health burdens and preventive strategies are urgently needed. (+info)
Standards of the in vitro mutation frequency study and the antimicrobial activity study in gut.
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In view of the recent rapid increase in incidence of infection with antimicrobial resistant bacteria in human medicine, there is international controversy as to the medical risk that is created by transfer of antimicrobial resistant bacteria and antimicrobial resistant genes, which may be produced through the processes of administration of antimicrobials to food-producing animals, via the food chain. Accordingly, International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) provides the comprehensive guidelines for characterizing selection of antimicrobial resistance by bacteria which may adversely affect human health in order to establish the system of registry of antimicrobial drugs to be administered to food- producing animals. Currently, Japanese Society of Antimicrobials for Animals recognizes the lack of technical test standards in compliance with VICH guidelines in the world and has established the test standards for "in vitro mutation frequency studies" to evaluate the appearance frequency and resistant level of resistant bacteria and those for studies on the "antimicrobial activity in gut" to estimate the effects on intestinal flora from professional aspects. (+info)
The need for a focus on air pollution research in the elderly.
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During recent years an increasing focus has been directed towards the adverse health effects associated with ambient air pollution. Elderly people appear to be particularly susceptible to the adverse effects involving the respiratory and cardiovascular systems, resulting in symptoms, exacerbations of disease and even mortality. From an epidemiological point of view it is essential to obtain a more detailed description and identification of factors associated with these health effects. Novel study designs are needed with complementary exposure and biomedical characterisation. Long-term prospective studies are required. A better understanding of the pathophysiological mechanisms is considered important and requires an interaction between epidemiological and mechanistic studies in elderly individuals with or without complementary diseases that put in them especially at risk. Generally a synergy between complementary disciplines is warranted to move this important research area forward, also including in vitro models of cell responses in the elderly, animal models of diseases of the elderly, together with controlled air pollution exposure studies identifying health-related events and mechanisms. The generation of an understanding of air pollution effects in the elderly, at an elevated level, is a prerequisite to substantially reducing the adverse health effects of this population group. At local, national and European Union levels, some steps have been taken to support the research in this area. A major focus on the adverse air pollution effects in the elderly requires a long-term commitment that still remains to be established. (+info)
An empirical survey on biobanking of human genetic material and data in six EU countries.
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Biobanks correspond to different situations: research and technological development, medical diagnosis or therapeutic activities. Their status is not clearly defined. We aimed to investigate human biobanking in Europe, particularly in relation to organisational, economic and ethical issues in various national contexts. Data from a survey in six EU countries (France, Germany, the Netherlands, Portugal, Spain and the UK) were collected as part of a European Research Project examining human and non-human biobanking (EUROGENBANK, coordinated by Professor JC Galloux). A total of 147 institutions concerned with biobanking of human samples and data were investigated by questionnaires and interviews. Most institutions surveyed belong to the public or private non-profit-making sectors, which have a key role in biobanking. This activity is increasing in all countries because few samples are discarded and genetic research is proliferating. Collections vary in size, many being small and only a few very large. Their purpose is often research, or research and healthcare, mostly in the context of disease studies. A specific budget is very rarely allocated to biobanking and costs are not often evaluated. Samples are usually provided free of charge and gifts and exchanges are the common rule. Good practice guidelines are generally followed and quality controls are performed but quality procedures are not always clearly explained. Associated data are usually computerised (identified or identifiable samples). Biobankers generally favour centralisation of data rather than of samples. Legal and ethical harmonisation within Europe is considered likely to facilitate international collaboration. We propose a series of recommendations and suggestions arising from the EUROGENBANK project. (+info)