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The International Conference on Harmonisation's electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, the goal is the electronic transfer of drug applications and their review across submission formats, procedures, and regions. However, it is still unclear whether implementing eCTD really brings more advantages than disadvantages and, if so, for what kind of companies. After an expert interview was conducted in 2009, this research study was formed as an international survey officially supported by the European Medicines Agency in 2010. Overall, 963 responses were received, and 397 were used for the subsequent study analysis. Although a three-fourths majority of those with eCTD experience reported disadvantages in implementing eCTD, an overwhelming majority of the same group reported advantages that outweighed the disadvantages, some of them significantly. More than three-quarters of individuals with eCTD experience were able to shorten their total time to approval, and more than 90% of this group was able to demonstrate cost savings relative to paper submissions, regardless of their company kind, size, or number of submissions. [ABSTRACT FROM AUTHOR]

This paper is concerned with the River Danube as a European object that articulates forms of relations which, by linking human and non-humans in highly specific ways, create actor-networks that dispute common societal divisions and (b)orders. By discussing the contested social relevance of the River Danube, this paper visualizes different ways of imagining Europe. Following some of the controversies concerning the River Danube, we outline a process oriented, transnational research agenda for a specific European object with the conceptual explication of human and non-human relations at its core. [ABSTRACT FROM AUTHOR]

A large body of literature shows the link between inadequate housing conditions and poor physical and mental health. The aim of this paper is to summarize the research on the impact of local housing policies on health inequalities, focusing on the issues of access to housing and fuel poverty as studied in the SOPHIE project. Our case studies in Spain showed that people facing housing insecurity, experienced intense levels of mental distress. We found that access to secure and adequate housing can improve the health of these populations, therefore, public policies that address housing instability and their consequences are urgently needed. Housing conditions related to fuel poverty are associated with poorer health and are unevenly distributed across Europe. We found possible positive effects of façade insulation interventions on cold-related mortality in women living in social housing; but not in men. Policies on housing energy efficiency can reduce the health consequences of fuel poverty, but need to be free to users, target the most vulnerable groups and be adaptable to their needs. [ABSTRACT FROM AUTHOR]

This paper is divided into two parts: In the first part, the model room VOC measurement concept is evaluated with specimens from different construction materials in order to estimate the safety margins when using day 28 as the time point for indoor air quality assessment. Safety margins between 2 and 20 were estimated for softwood-based products. In the second part, the theoretical restrictiveness of ECA-IAQ Report 18 derivative schemes (like AgBB or NH 105) towards the indoor-related industrial production in central Europe was evaluated. [ABSTRACT FROM AUTHOR]

This paper presents a critical evaluation of the two different approaches to the study of bilingualism among linguistic minorities. For the most part, it draws on work related to the situations of regional minority languages in Europe. The focus is on the ways in which the conceptual framework developed within each of the two approaches reflects the influence of particular schools of thought in the social sciences and particular ways of thinking about social relations and social action. The paper deals first with the notions of "diglossia" and "domains of language use" and shows how these notions are derived from structuralist and functionalist views of language and society. Several constraints are then outlined, that are inevitably imposed on the study of bilingualism by constructs developed within a structural-functional framework. The second part of the paper, turns to work, which represents quite a different approach to bilingualism. The final section of the paper looks at a third area of work on bilingualism among linguistic minorities which has not received the attention it deserves. Contributions in this area have come primarily from anthropologists, sociologists and linguists concerned with regional minority languages in Europe.

The aim of this paper is to provide an overview for non-specialists of the body of law relating to equality of opportunity between women and men under European Community law. The paper considers the history of the development of equality law in EC law, describing the development of Article 119, the development of the three most important directives in the 1970s, the growth of litigation surrounding Article 119 and these Directives, the controversy over supplementary directives in the 1980s, the adoption of the Pregnancy Directive in the 1990s, and the increasing use of 'soft law' instruments such as in the area of equal pay and sexual harassment. The paper considers how the jurisprudence of the European Court of Justice has interpreted these legal provisions, concentrating on various themes: the concept of 'indirect discrimination', the appropriate use of positive action policies, and the meaning of equal pay for work of equal value, amongst other issues. The paper considers how these provisions are enforced. It sets out the role of the Commission in bringing infringement actions, the role of individual litigation in the Member States' courts, and the role of the European Court of Justice under Article 177 references. In particular, the paper considers the extent to which the Court of Justice has scrutinised the adequacy of national enforcement of equality rights, and the principles underlying legal remedies for breach of European equality law. Finally, the paper considers the factors which are likely to influence the future of equal opportunities law in the European Community in the near future. [ABSTRACT FROM AUTHOR]

There is a need to critically address the latent conceptual ambiguities in the pan-ethnic Eurasian label, and how it functions within the Singapore nation state’s ethno-racial regimes of representation. In response, this paper provides conceptual clarity by discussing the reaches and limits of this term as a floating signifier, as well as how it can be better operationalized as a modality of research. As a prelude to calling for a departure from understanding subjectivities within the city-state’s containment categories of ethnicity that have been legally institutionalized as ‘races,' it is argued that the monolithic racial label ‘Eurasian,' as well as the variegated cultural identities it is assumed to represent, need to be critically interrogated. [ABSTRACT FROM PUBLISHER]

This paper is a reflection, on the basis of empirical research conducted in Italy, on theoretical, methodological and systemic-organisational aspects linked to the recognition and validation of the prior learning acquired by adult learners or workers who decide to enrol at university at a later stage in their lives. The interest in this research theme derives from the continuously growing number of adults who enrol on graduate degree programmes. The growing national and European debate on the reform of educational systems which ensued from the Bologna Process is focused on the development of a bridging system between the formal systems of education and the non formal and informal learning contexts, in view of developing validation procedures for prior learning. The research method, which combined both qualitative and quantitative approaches, consisted in a national survey on the basis of a questionnaire submitted to all the Italian universities and used methods of qualitative orientation, such as Bilan de Competénces and Biographic Laboratory. The survey helped to identify instruments and organisational procedures for the validation of prior vocational learning. Moreover, on the basis of the research conducted and keeping in mind the international setting, it can be stated that it is only from the perspective of lifelong learning that universities can approach the object at issue. [ABSTRACT FROM AUTHOR]

Increasing respondent contact problems and decreasing respondent willingness to cooperate have contributed to declining response rates in general population surveys, which has raised concerns of survey accuracy. To counteract nonresponse, several methods have been employed, including incentives, advanced letters, alternative survey modes for reluctant respondents, and increased field efforts to contact potential respondents. In particular, the number of contact attempts has been increased for many surveys. Even though more contact attempts increase survey costs, they are a reliable means for increasing response rates. However, the assumption that high response rates foster data quality and smaller nonresponse bias has been challenged. In this paper, we used contact data from the European Social Survey for Norway, Finland and Slovenia to see whether or not additional contact attempts resulting in a higher response rate can potentially reduce nonresponse bias. [ABSTRACT FROM PUBLISHER]

Being confronted with the import of formerly unknown cultural practices, the European public authorities are expected to set clear public standards regarding the alleged harmful nature of such practices. The adopted solutions are often of a legal nature, using the law as a vehicle to frame certain social behaviour as socially unacceptable. One of the practices that have been subject to framing in terms of law and gender are what is commonly referred to as forced marriages. Calling upon human rights law, Europe's policy is in favour of penalization of forced marriages. However, such an appeal holds the risk of strategically misuse of human rights law for political benefit. Next to a clear risk penalisation being symbolic, diversity issues bear within a risk of xenophobia. Thus penalisation of diversity issues needs to be analysed scrupulously. This paper addresses the issue of the penalisation of forced marriages in Europe, with special attention paid to a draft law recently submitted by the Dutch government, addressing the issue which actors and factors have contributed forced marriages being put on the European and Dutch political agenda. [ABSTRACT FROM AUTHOR]

Abstract: This case study examines in detail the factors responsible for the emergence of a highly successful South-east Asian brand – MK Restaurants. MK restaurants is a privately owned company that has grown from humble beginnings to a chain of over 250 restaurants in Thailand and tasted success in expanding into Europe and Japan. Our analysis suggest that MK Restaurants has built the brand from through living a set of brand values, astute positioning that appeals to a wide demographic and the global trend towards healthier eating, and a marketing communications budget that exceeds McDonalds and KFC in Thailand. Furthermore, brand extensions, a genuine customer centric philosophy that is practiced at all levels in the firm, an adherence to the service-profit-chain concept (i.e., happy staff are more likely to deliver better service quality, which in turn drives customer loyalty and repeat patronage), and a state of the art logistic and supply chain system have all driven brand success. Key lessons for other service brands are drawn and explicated in the paper’s final section. [Copyright &y& Elsevier]

A literature review was conducted to facilitate allied health professionals' implementation of the recommendations made by the Prevention of Falls Network Europe (ProFaNE) (Yardley et al 2007a) on promoting older people's engagement in activities to prevent falls. The falls prevention literature was searched for relevant papers to aid allied health professionals' choice of strategies and to inspire ideas about how to implement ProFaNE's recommendations in everyday practice. Suggestions for each of the six ProFaNE recommendations are made, which may in turn promote older people's adherence to falls prevention interventions [ABSTRACT FROM AUTHOR]

Predischarge occupational therapy home assessments are routinely performed with older adults in Europe, Australia and North America. Their primary aim is to facilitate a timely and safe discharge from hospital. However, there is a lack of published research on this topic, especially studies exploring occupational therapists' perceptions of home assessments. The paper aims to redress this by describing occupational therapists' perceptions of predischarge occupational therapy home assessments with older adults in acute care. All occupational therapists who undertook home assessments in an acute care hospital with older adults during the duration of the study period were invited to complete a reflective diary. In total, 15 reflective diaries were completed by six therapists. The data were analysed using thematic content analysis. The findings suggest that home assessments were carried out because of mobility or environmental concerns. Satisfaction and dissatisfaction with the outcome of the home assessment were related to the incidents that occurred during the assessment. Some of the occupational therapists' anxieties were related to the older adults' level of functioning or ill health, and the older adults' own concerns did have an impact upon the therapists' expectations of the home assessment process. [ABSTRACT FROM AUTHOR]

The controversy concerning the patentability of gene based diagnostics has somewhat abated since the decisions at the European Patent Office on the Myriad patents. Nonetheless, whether it is in the public interest that patents over gene based diagnostics that otherwise fulfill substantive criteria should be available, remains a thorny issue. This article focuses on the patentability of preimplantation genetic diagnosis (PGD), which provides a means to test embryos generated by in vitro fertilisation (IVF) for a variety of inherited diseases, allowing the doctor to select only those without the defect for implantation in the uterus. The public health policy arguments advanced against the myriad patents and surrounding patents on genetic diagnostics generally could also apply to any patent application for a method which includes claims to PGD. This paper considers whether patent claims to PGD methods fall within the ambit of either the section 4(2) Patents Act 1977 'medical exclusion' (implementing the equivalent exclusion in Article 52(4) of the European Patent Convention), or the exclusion in Article 6 of Directive 98/44/DEC on the Legal Protection of Biotechnological Inventions. [ABSTRACT FROM AUTHOR]

This paper reports on a survey of perceived problems in the provision of orthodontic education at the stages of undergraduate, postgraduate, and continuing professional education (CPE) in 23 European countries in 1997. A questionnaire, together with an explanatory letter, was mailed to all members of the EUROQUAL II BIOMED project. Answers were validated during a meeting of project participants and by further correspondence, when necessary. The topics covered in the questionnaire were adequacy of funding, numbers of orthodontic teachers, availability of equipment, regulations, training centres, numbers of orthodontists, availability of books, journals, and information technology. Completed questionnaires were returned by orthodontists from all 23 countries. Respondents from seven countries did not answer all questions. Respondents reported a perceived almost universal lack of adequate funding for postgraduate orthodontic training (from 18 out of 20 countries) and, to a lesser extent, at undergraduate (13 out of 20 countries) and CPE levels (17 out of 21 countries). Respondents from 12 of the 20 countries reported adequate numbers of qualified teachers at undergraduate level, but only seven out of 18 at postgraduate level and eight out of 19 for CPE. Lack of suitable equipment was reported as a more frequent problem by central and eastern European countries (six out of 20 countries at undergraduate level, eight out of 20 countries at postgraduate level, and 12 out of 19 at CPE level). Too few or too many regulations were only perceived to be a problem by the respondent from one country out of 19 at undergraduate level, by seven out of 19 at postgraduate level, and by eight out of 16 at CPE level). Lack of training centres was more frequently reported as a problem by respondents from central and eastern European countries, but was generally not perceived as a problem by respondents from west European countries. Respondents from seven countries reported a lack of training centres for CPE. Respondents from six countries reported that they perceived there to be too many orthodontists at postgraduate level, from seven countries that there were an appropriate number, and from seven that there were too few. A lack of books, journals, and information technology was reported to be a problem by respondents from four out of 19 countries at undergraduate level, eight out of 20 at postgraduate level, and 10 out of 20 at CPE level. At both undergraduate and postgraduate level, the majority of respondents from central and eastern European countries reported problems with books, journals, and information technology. The results of the survey confirmed many anecdotal impressions and provided an extremely useful background against which to formulate quality guidelines for orthodontic education in Europe. [ABSTRACT FROM AUTHOR]

This paper reports on a survey which was undertaken to investigate the delegation of orthodontic tasks and the training of chairside support staff in Europe. Two questionnaires were posted to all members of the EURO-QUAL BIOMED II project together with an explanatory letter. The first dealt with the delegation of nine clinical tasks during orthodontic treatment. The second with the types of chairside assistant employed in each country and the training that they are given. Completed questionnaires, which were subsequently validated, were returned by orthodontists from 22 countries. They indicated that there was no delegation of clinical tasks in six of the 22 countries and delegation of all nine tasks in five countries. The most commonly delegated tasks were taking radiographs (in 14 of the 22 countries) and taking impressions (in 13 of the 22 countries). The least commonly delegated tasks were cementing bands (in five of the 22 countries) and trying on bands (in six of the 22 countries). Seven of the 22 countries provided chairside assistants with training in some clinical orthodontic tasks. Eighteen of the 22 countries provided general training for chairside assistants and offered a qualification for chairside assistants. Four of these 18 countries reported that they only employed qualified chairside assistants. Of the four countries which reported that they did not provide a qualification for chairside assistants, two indicated that they employed chairside assistants with no formal training and two that they did not employ chairside assistants. It was concluded that there were wide variations within Europe as far as the training and employment of chairside assistants, with or without formal qualifications, and in the delegation of clinical orthodontic tasks to auxiliaries was concerned. [ABSTRACT FROM AUTHOR]

This paper reports on a survey of teaching contents and time allocation within the undergraduate orthodontic curriculum in European countries in 1997, and on whether or not these countries set a formal undergraduate examination in orthodontics. A questionnaire and an explanatory letter were mailed to all members of the EURO-QUAL BIOMED II project. Answers were validated during a meeting of project participants and by fax when necessary. Completed questionnaires, which were subsequently validated, were returned by orthodontists from 23 countries. They indicated that orthodontics was taught in all undergraduate curriculums of the countries surveyed. The number of hours in the undergraduate curriculum devoted to orthodontics was reported as varying from 135 to 500 hours with a mean of 245 hours. The time reported as allocated to theory, clinical practice, laboratory work, diagnosis, and treatment planning varied widely. In general, clinical practice and theory were reported as being allocated most curriculum hours, whilst diagnosis, laboratory work, and treatment planing were reported as receiving relatively less time. Removable appliances were reported to be taught in 22 of the 23 countries, functional appliances in 21 countries and fixed appliances in 17 countries. An undergraduate examination in orthodontics was reported by 20 countries. It was concluded that orthodontics occupies a small proportion of the undergraduate curriculum in dentistry in most countries, the emphasis is on theory and clinical work, and that removable appliances, functional appliances, and certain aspects of fixed appliances are taught in the majority of countries that responded to the questionnaire. [ABSTRACT FROM AUTHOR]

This paper reports on a survey of the duration, funding, and assessment of postgraduate specialist orthodontic training, the requirement for postgraduate training prior to entering specialist orthodontic training and registration of specialist orthodontists in Europe. A questionnaire and explanatory letter were mailed to all members of the EURO-QUAL BIOMED II project. Answers were validated during a meeting of project participants and by fax, when necessary. Completed questionnaires which were subsequently validated, were returned by orthodontists from 23 countries. The results indicated that a period of postgraduate training, prior to entering specialist orthodontic training was required in 12 of the responding countries. Specialist orthodontic training was reported as lasting 2 years in three countries, 3 years in 17, and for 4 years in three. Part-time training was reported as a possibility in four countries. In 21 of the 23 countries specialist training was reported to take place in full or part within universities, with some training taking place in government clinics in four countries. In five countries some or all training was reported to take place in specialist practices. Training was said to be funded solely or partially by governments in 15 of the 23 countries, to be solely self-funded in five countries, and partly or solely funded by universities in six countries. A final examination at the end of specialist training was reported to be held in 21 of the 23 countries. The nature of this examination varied widely and there was no such examination in two countries. Twelve of the 23 countries reported that they had a specialist register for orthodontics; 11 that they had no register. In none of the countries surveyed was there a requirement for those on a register to undergo periodic reassessment of competence once they are on the register. It was concluded that there was wide diversity in all aspects of specialist orthodontic training and registration within the countries surveyed. [ABSTRACT FROM AUTHOR]

The object of this paper is to highlight and scrutinise the continuing difficulties which characterise national and European judicial efforts to reconcile the apparently conflicting needs of the workplace and its pregnant workers. In particular, the prevailing dominant legal conceptualisation of pregnancy as an aspect of sexual equality generates an unsatisfactory indeterminacy and manipulability in relation to the determination and application of women's legal rights. This is well illustrated in the decision of the European Court of Justice in Gillespie v Northern Ireland Health and Social Services Board [1996]. Both the decision itself and its legal aftermath suggest that the difficulties traditionally associated with the application of the equality principle to the condition of pregnancy are far from resolved. [ABSTRACT FROM AUTHOR]

This paper discusses the new economic and social tendencies of the European civilization. Individual freedom and political rights and national sovereignty and independence have been governing the ideals of the modern world. While they have been conquering public opinion and being given conscious political sanctions, a new set of social and economic conditions have been coming into existence. The age of nationalism has been marked by the growing internationalization of social and economic life. At the time of the French Revolution, each European people was distinct in its culture, its customs, its ways of thought, event its costumes. The victory of political liberalism and the acquisition of individual liberties appear to have been accompanied by an increasing loss of individual independence and initiative in the ordinary business of life. This also is the result of economic causes. It has come about that the center of social gravity has shifted from the political to the economic field. People still preserve the old political forms, but it is the economic issues that control their lives. The true feature of the new society, according to professional historian M. Lucien Romier, is not the class struggle but the growth of great economic interests which transcend the boundaries of nation and class.

This paper discusses the existence of an open-field type of cultivation in Mediterranean lands and in the Atlantic Coastal lands of south west Europe. In certain islands of Brittany, France traces of an open-field type of cultivation still exist. Exposure to the westerly winds retards, and in many cases entirely prevents, the growth of trees, but in sheltered spots they may be found, as well as such sun-loving plants as mimosa, myrtle and vine. The islanders are occupied with fishing and farming. In the Balearic Islands also, the Minorcans are fishermen, while the Mallorcans have been enterprising navigators from earliest times. In all these islands the sillon is the basis of land tenure, and many sillons are cultivated in common. Communal methods of working were also characteristic of other occupations in the islands. The fertility of the soil is maintained by the application of manure in the form of seaweed, and there are very strict regulations concerning the cutting of this plant. In Ile d' Arz, France, with a two-field scheme, the ancient jachère morte has been replaced by the Jachère verte or green fallow. Barley and wheat, both varying in their species as much as the soil varied in its composition, were the cereals most usually grown. The mountains in Greece have limited the extent of the fertile land, and the dry climate has limited its green pastures.

In a paper which the author had the honour of writing for the "Sociological review," the author attempted to describe the regional and vocational influences that produced the ancient architecture of Mesopotamia, Egypt, Greece, Rome and medieval Europe-the place, work and folk, and the resultant habitations. The river and the clay buildings of Mesopotamia, the river and the clay transmuted into granite for the buildings of Egypt, the mountain stone and marble buildings of Greece and Rome and the forest and timber buildings, afterwards translated into stone of Northern Europe. In all countries throughout the ages, the great building people have always been the agriculturalists, the peasants. Their settled place of abode-the regular routine of their seasonal duties gave a permanence to their works that the other vocations missed. If the sailor has not the high spiritual imagination of the shepherd, he has many other valuable qualities, and an imaginative range that even exceeds the shepherd's. His vocation brings him into contact with foreign countries and men of all nations; he is a trained observer and has ample time during his long voyages to meditate and digest what he has seen.

The purpose of this paper is to explore some of the features of the history of sociology and to indicate the lines upon which enquiries may be pursued, to see to what extent the development of sociology is itself a historical phenomenon of a unique kind and to locate its origins. The history of sociology may well be perceived to fall into two parts,an early period of mainly speculative activity and a later period of empirical, albeit limited studies. Throughout its history we can detect periods particularly favourable to the development of the subject, but whilst the conflicts of a process of industrialisation in Europe, especially in recent times, may account for much of this development and, whilst these vicissitudes in Europe and elsewhere may have increased the swell of a new intellectual wave, sociology sailed on a tide which began to flow much earlier, and which is to be seen in the currents of eighteenth century philosophical thought, rather than in the plash of nineteenth and twentieth century economic and social turbulence.

The suggested guidelines for the provision and assessment of Orthodontic education in Europe, which are introduced, set out, and discussed in this paper, resulted from the work of the Professional Development Group (PDG) of the EURO-QUAL BIOMED II project. They were published in the final report of the project, after comments had been received from a range of national and European bodies and societies, including the British and the European Orthodontic Societies, Royal Colleges, and the General Dental Council. [ABSTRACT FROM AUTHOR]

This section offers news briefs related to veterinary dentistry. Activities during the 12th European Congress of Veterinary Dentistry held in Pisa, Italy included a gala dinner sponsored by lams, small group wet laboratories and presentations that featured 28 papers. The British Veterinary Dental Association (BVDA) conference will be held in Birmingham, England on March 31, 2004. The first Spanish Society of Veterinary and Experimental Dentistry and Maxillofacial Surgery (SEOVE) annual meeting has been scheduled for March 2004 in Madrid.

The article presents the paper "European Approaches to Security Sector Reform: Examining Trends Through the Lens of Afghanistan," by Mark Sedra which appeard in the "Journal of European Security." It examined the need for new debate on security sector reform in Europe as demonstrated in the Afghanistan process.

The article discusses the highlights of the 11th European Veterinary Dental Congress held on October 1-2, 2002 in Granada, Spain. University professor and oral pathologist David Gardner delivered his keynote speech on a topic entitled "Odontological Tumors in Animals With an Emphasis on Dogs and Cats." Finnish Doctor Helene Kuntsi-Vaattovaara was given the European Veterinary Dental Award for her paper entitled "Results of Root Canal Treatment in Dogs: 127 Cases (1995-2000)."