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PubMed1993

Status of the GCP guidelines in Europe.

Two key factors are of main importance for the development of a common GCP legislation in the Member States of the European Community: 1) July 1991, Enforcement of the EEC Note for Guidance: "Good Clinical Practice for Trials on Medicinal Products in the European Community". This enforcement was setting into operation GCP guidelines which were, however, not yet legally binding at that time. 2) January 1992, Enforcement of EEC Commission, Directive 91/507/EEC: Analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of medicinal products. By this enforcement the EEC Member States were obliged to bring into force the laws, regulations and administrative provisions necessary to comply with the Directive which requests--besides others--all clinical trials to be designed, implemented and recorded in accordance with GCP. Facing the different national regulations covering clinical trials already being in force at that time, some of the European countries are considered to already be in compliance with EEC-GCP. In other countries, however, the Directive causes situations in which EEC-GCP is more demanding than the existing legislation or even contradictory. Country by country this has to be regulated soon by appropriate measures of the legislators in order to establish a uniform standard which will assure clinical trials to be internationally acceptable. Only recently the CPMP introduced the requirement for a "Compliance with GCP" Statement as an indispensable part of the Clinical Expert Reports in registration documentations. Even more than in legislation, there is a lack of inspections in clinical trials by health authorities in most European countries.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Protocols↗
PubMed1984

Comparison of three methods for detection of prolonged experimental trichinellosis in pigs.

Three methods were employed for the diagnosis of porcine trichinellosis. The pooled sample digestion method and trichinoscopy served as European Community (EC) reference techniques, whereas the reliability of the Enzyme Linked Immunosorbent Assay (ELISA) was tested by 11 laboratories of the European Community and Sweden. Three groups of 6 piglets each were orally inoculated with 50, 150 and 1500 Trichinella spiralis larvae into each animal. Another group of 6 animals served as a non-infected control. Animals were slaughtered and serum and muscle samples were collected at Weeks 4, 12 and 40. The material was mailed under code and examined in all participating laboratories. ELISA proved to be a sensitive technique. ELISA micro assay was the most sensitive procedure. Of the direct techniques the reference pooled sample digestion method was more sensitive than trichinoscopy. It was concluded that both micro and macro ELISA can be used with confidence for the detection of low grade, longstanding experimental T. spiralis infections in swine.

Animals↗
PubMed1995

Validation of a screening liquid phase blocking ELISA for swine vesicular disease.

A direct liquid-phase blocking ELISA (LPBE) was developed for serological examination of swine vesicular disease (SVD). The sensitivity and specificity of the test were assessed on 272 and 365 sera collected on two farms where an outbreak had occurred. The specificity of the direct LPBE was higher than the specificity of the indirect LPBE. The European Community reference serum for SVD (RS 01-04-93), which has been adopted as the threshold for SVD serological examination in the European Community, had a mean titre of 2.19 in the neutralisation test. At a cut-off level of 2.0 in the neutralisation test, the sensitivity of the direct LPBE (screening at 1:432 final dilution) on the two farms was 90% and 99%, respectively. Based on these results, the screening dilution of the direct LPBE was adjusted to 1:160 final dilution, to obtain a sensitivity > or = 98% on both farms. Regression analyses showed a good correlation between the virus neutralisation test and the direct LPBE (r = 0.87). Compared to the indirect LPBE described before, the direct LPBE correlates better with the neutralisation test, has a higher specificity, and is more rapid. Because sera are tested in only one dilution, the test is highly suitable for the examination of large numbers of serum samples.

Animals↗
PubMedDate not supplied

Health care delivery systems: effects on surgical education in Italy.

Since 1989 a national health system (NHS) has been in effect in Italy based on the constitutional principle that health care is a right of all citizens. Until 1992 the NHS had a secondary role in medical education, as the 33 medical schools for postgraduate training are under the control of the Ministry of University. The European Community legislation allowing free movement of M.D.s and specialists between member countries has resulted in standardization of teaching programs and formative curricula in the European Community. Therefore beginning in 1992, every 3 years the Ministry of Health and University establishes the number of specialists that can meet the needs of the NHS and allocates funds to each school for the salary obligations. The actual number of paid residents for surgical specialties is 941 per year (192 for general surgery). Until recently surgical training in Italy was mainly theoretic, as no legislation guaranteed that physicians in training would perform surgery. New legislation, increased exchanges with European hospitals, and improved and loyal cooperation between universities and the NHS will certainly improve the situation in coming years.

Delivery of Health Care↗
PubMed1988

City spore concentrations in the European Economic Community (EEC). VII. Oleaceae (Fraxinus, Ligustrum, Olea).

In this paper we present the results of volumetric sampling of the airborne pollen grains of the Oleaceae family (Fraxinus, Ligustrum and Olea) in some European towns, in the period from 1982 to 1986. The sampling and appraisal of pollen content in the air is of particular interest to clinicians and allergic patients in order to assess exposure to the various pollen types in relation to allergy. In the Oleaceae family, the most allergenic pollen is produced by Olea europaea, the olive tree, which in the Mediterranean area has a pollination period lasting from May to the end of June and sometimes causes severe symptoms of pollinosis. In Northern and Central Europe, where there are no olive trees, there are two other commonly occurring genera of the Oleaceae family, namely Fraxinus and Ligustrum, but these have a low frequency of allergic sensitization.

Air Pollution↗
PubMed1995

[The current status in obtaining a license for the practice of dentistry in the European Union and the United States of America].

Present regulations on the issuance of dental licenses are very different between the United States of America and the European Community. Two different mechanisms attempt to arrive at the fairest possible solution: licenses controlled by either national and/or local examinations in the United States, and licensing by credentials in the European Community. Both are compared and discussed.

Credentialing↗
PubMed1976

Role of the practitioner, public health officer, dermatologist, and other specialists in the teaching, investigation and treatment of STD. The situation in the Common Market countries.

The training of undergraduates and postgraduates in the original member countries of the European Community (Belgium, Federal Republic of Germany, France, Italy, Luxemburg, and the Netherlands) is outlined and compared with training in the U.K. and Ireland. It is noted that, in the European Community, training is inadequate and should be improved. Harmonizing with the U.K. will require concessions to be made on both sides.

Dermatology↗
PubMed1992

[The control of foodstuffs at the beginning of 1993].

The 1st January 1993 the frontiers between the Member States of the European Community and the customs controls will disappear. The abolition of this type of control won't affect the food security. The french administration has strong legal rules to ensure the protection of consumer's health. The regulations prepared by European Community in order to allow the free circulation of goods also ensure a high level of consumer's protection. In case of harmonization, each Member state keeps some rights when there are risks for consumer's health. In absence of community regulations the principal of mutual acknowledgement aiming to avoid the barriers to trade can then not be applied for health and security necessities. The authorities controls are now resolutely inserted in an european context: priority to controls during production, harmonized methods of intervention to promote the required acknowledgement of controls enforced in each Member state, involvement in an european alert system, and development of the cooperation between the national administrative authorities of inspection. Regarding the matter of food security the authorities need the assistance of the scientific community and of its national and international representative organisations. They take an essential part in diagnosing, emergency and advice during the elaboration of regulations. Their power should be even greater with the implementation of the european scientific cooperation.

European Union↗