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PubMed1999

[Professional profile and responsibility of the qualified person within the European Union].

The European Community has established a fundamental condition for opening a pharmaceutical laboratory, i.e. the designation of a qualified person having the professional profile detailed in the European Community Directive and who is responsible for implementing specific obligations. It is the final responsibility of this qualified person to release medicine on the market. Do to the importance of this person, we have analyzed his/her functions, obligations and responsibilities. The training required to fulfil the functions of a qualified person is presented. The profiles of qualified persons in the most representative European countries are discussed to demonstrate analogies and differences in national legislations and their adaptation to European Community regulations.

Drug Evaluation↗
PubMed2005

Validity of process indicators of screening for breast cancer to predict mortality reduction.

The aim of the study was to empirically assess the acceptable levels of process indicators as described in the European Community Guidelines using materials from the mammography service screening programmes. The Finnish programme was evaluated for effectiveness with a prior estimate of 0.74 for RR in Finland and 0.81 in Helsinki. Hence, the Finnish programme was likely to be somewhat less effective in terms of reduction in mortality than implied on the basis of early randomized trials, but probably approaching the same level of effectiveness. Finland therefore provides background data on the applicability of the process indicators that are indicators of performance and surrogates for effectiveness. The performance data on 10 Finnish screening centres at subsequent screens were used. These centres invited 687,000 women aged 50-64 years in 1991-2000. The mean compliance was 93% and the corresponding recall rate was 2.3%. The benign to malignant biopsy ratio was 0.43:1. The average breast cancer detection rate was 0.36%, 2.1 compared with the background incidence. The proportion of screen-detected stage II+ cancers was 26%. Most, but not all, of these process indicators met the desirable reference values of the European Community. The specific criteria of the European Community on stage distribution, rates of screen-detected cancers by stage and detection rate to background incidence may need reconsideration.

Biopsy↗
PubMed2002

Two decades of "research-practice" encounters in the development of European therapeutic communities for substance abusers.

In 1981, a "research-practice" breakthrough was realized through the foundation of the European Federation of Therapeutic Communities (EFTC). Since its foundation EFTC regularly organized conferences and symposia. A few years later (in 1983), the European Workshop On Drug policy Oriented Research (EWODOR) was established at the Erasmus University in Rotterdam, including a special section devoted to the therapeutic community (TC). The authors examined the proceedings of all meetings organized by EFTC and EWODOR. The major topics presented throughout the last 20 years are highlighted in a chronological selection and these presentations largely focus on the challenges of the TC and the state of the art regarding scientific knowledge. In this overview only those authors who published articles in scientific journals indexed in the "Web of Science" (Institute for Scientific Information-ISI) were retained. Although research has never been the primary consideration in TCs, it played a far from negligible role in its development. Research findings prompted innovations and thus often provoked resistance, but on the other hand they functioned as a catalyst between the necessity of a belief system and the reality of society. The role of "grey" literature and the availability of information through the Internet will become more and more important in the communication between researchers and practitioners.

Communication↗
PubMed2004

Building knowledge driven and dynamically networked communities within European healthcare systems.

COCOON is an innovative project developed in the e-health area of the Sixth Framework Programme co-financed by European Commission. It is an Integrated Project aimed at supporting health care professional in reducing risk management in their daily practices by building knowledge driven and dynamically adaptive networked communities within European healthcare systems.

Computer Communication Networks↗
PubMed2006

Quality assessment of CoaguChek point-of-care prothrombin time monitors: comparison of the European community-approved procedure and conventional external quality assessment.

BACKGROUND: There is a need for dependable quality assessment (QA) of the widely used CoaguChek point-of-care testing prothrombin time monitor. By use of the prescribed set of 5 CoaguChek certified international normalized ratio (INR) QA plasmas, we compared the reliability of the immediate QA of individual monitors described in the European Community-recommended Technology Implementation Plan with conventional external QA analysis. METHODS: Experienced staff tested CoaguChek point-of-care monitors in routine use for controlling oral anticoagulant dosage at 9 Netherlands Thrombosis Service Centres. Testing was performed with both the certified CoaguChek INR for a set of 5 QA individual plasmas from the Eur Con Action on Anticoag (ECAA) and conventional external QA analysis. RESULTS: Patients brought 523 CoaguChek monitors to our service centers for assessment. The proportion with unsatisfactory performance indicated by a 15% deviation from the ECAA set was compared with 15% deviation from overall median INR of all CoaguChek monitors in the survey, as in conventional QA analysis. The results were similar (20.3% and 18.5%, respectively). Interlot differences of CoaguChek test strips were detected, but the incidence of unsatisfactory performance was similar with both analyses, from 6.5% to 37.5% with the certified INR method and from 5.9% to 33.3% with the overall median analysis. CONCLUSIONS: The results validate the use of the European Action on Anticoagulation rapid single-instrument QA-specific procedure for CoaguChek users compared with the nonspecific conventional QA analysis that relies on deviation from the overall median INR.

Administration, Oral↗
PubMed1976

City spore concentrations in the European Economic Community (EEC) I. Grass pollen, 1973.

Although clinical reports on the prevalence of summer hay fever in different parts of Europe have been published, comparative studies on atmospheric pollen concentrations appear to have been rarely undertaken. The present paper describes observations on the grass pollen content of the air at Bologna, Brussels, London, Munich and Strasbourg and is the first of a series involving international collaboration between workers in cities of the European Economic Community.

Air Pollutants↗
PubMed1983

[Registration of congenital malformations in Paris. Evaluation and perspectives of a study carried out under the auspices of the European Economic Community].

Since 1976 a registration of congenital malformations has been gradually set in Paris. At present it covers 95% of the births registered in this department which amount to 38,925 births in 1982. Since 1981, it has been extended to include malformations diagnosed during the first month of life in neonatal units in Paris, for residents in Paris, and also a register of therapeutic abortions for congenital abnormalities. It is part of the 17 registers which have been started on the initiative of the European Economic Community. The results of the frequency of different types of congenital malformation are given for the years 1978 to 1982. The value of this register as epidemiological information and the studies that have been carried out with a view to determining aetiology are discussed.

Congenital Abnormalities↗
PubMed2000

Harmonization of vascular surgical training in Europe. A task for the European Board of Vascular Surgery (EBVS).

The competence of vascular surgeons defined as the level of skill, knowledge and experience necessary to safely perform vascular surgical procedures is determined to a high degree by the quality of the preceding training. In Europe, quality assurance of vascular surgical training, unlike in the USA, is not uniform and is not the responsibility of a centralized European authority, but is a matter in which the different countries have autonomous regulations. Consequently, different targets for duration, contents and general principles for training in vascular surgery have been set. Although in the past this may not have been a problem, the unification of countries in the European Community (EC), at present known as the European Union (EU), has changed this perspective because there is increasing impetus towards a mutual recognition of trade and education between member states. In 1975, EC directive 75/362 was adopted, which insured 'freedom of migration' for medical doctors along with many other professional trades (Publications of the European Communities no. L167, 30-6-1975, p. 1). This directive implicated that certificates, diplomas and other documents issued by the national competent authorities proving medical qualification allowed physicians to practice in any EU country. In order to make this law practical it seems essential that specialist training programmes throughout the EU should conform to certain agreed basic standards. The objective of this article is to present an overview on the current pattern of vascular surgical training in Europe. In addition, the structures that were established during the recent years to promote uniformly high standards of training in vascular surgery throughout the EU will be discussed.

Education, Medical, Continuing↗
PubMed2006

Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations.

PURPOSE: There is a need for valid and reliable short scales that can be used to assess social networks and social supports and to screen for social isolation in older persons. DESIGN AND METHODS: The present study is a cross-national and cross-cultural evaluation of the performance of an abbreviated version of the Lubben Social Network Scale (LSNS-6), which was used to screen for social isolation among community-dwelling older adult populations in three European countries. Based on the concept of lack of redundancy of social ties we defined clinical cut-points of the LSNS-6 for identifying persons deemed at risk for social isolation. RESULTS: Among all three samples, the LSNS-6 and two subscales (Family and Friends) demonstrated high levels of internal consistency, stable factor structures, and high correlations with criterion variables. The proposed clinical cut-points showed good convergent validity, and classified 20% of the respondents in Hamburg, 11% of those in Solothurn (Switzerland), and 15% of those in London as at risk for social isolation. IMPLICATIONS: We conclude that abbreviated scales such as the LSNS-6 should be considered for inclusion in practice protocols of gerontological practitioners. Screening older persons based on the LSNS-6 provides quantitative information on their family and friendship ties, and identifies persons at increased risk for social isolation who might benefit from in-depth assessment and targeted interventions.

Aged↗
PubMed1992

New developments in clinical testing of medical devices for Europe 1992.

The unification of Europe is associated with the introduction of many new regulations aiming at, for example, standardization and quality control. Several of these generally normative regulations are pertinent to clinical investigations of medical devices, such as heart valves, pacemakers and cardiac assist devices. Relevant documents dealing with these regulations are the "Guidance for good clinical practice for trials on medicinal products in the European Community," a standard already passed by the European Parliament, and CEN (Comité Européen de Normalisation) document TC258 dealing with "Clinical investigations of medical devices". The latter standard is in discussion among member states of the European Community. In this present survey the most important issues dealt with in these documents will be summarized with emphasis on the aspects relevant to clinical investigations of medical devices.

Equipment and Supplies↗
PubMed1980

City spore concentrations in the European Economic Community (EEC). IV. Summer weed pollen (Rumex, Plantago, Chenopodiaceae, Artemisia), 1976 and 1977.

This paper describes observations on the airborne pollen concentrations of four anemophilous weeds of very common occurrence in Western Europe, viz. Rumex spp .(sorrel and dock), Plantago spp. (plantain), Chenopodiaceae (goosefoot family) and Artemisia spp. (mugwort). Comparative results are recorded from London, Leiden, Brussels, Munich and Marseilles for the summers of 1976 and 1977 and this study is one of a series involving international collaboration between workers in cities of the European Economic Community. The literature on the clinical significance of summer weed pollen is reviewed and it is concluded that the pollen of Artemisia is likely to be of importance in areas where the weed is of common occurrence in late summer. The pollen of the other summer weeds is unlikely to be important, but may contribute to the problems of the pollen sensitive patient under exceptional circumstances.

Air↗