543 research outputs found
Assessing the sensitivity and representativeness of the Belgian Sentinel Network of Laboratories using test reimbursement data
Internationalised banking, alternative banks and the Single Supervisory Mechanism
This paper sets out to explain the preferences of the seven northern euro area member states on the Single Supervisory Mechanism (SSM) concerning the threshold set for direct European Central Bank (ECB) control over bank supervision. Building on the concept of the ‘financial trilemma’, it argues that different bank internationalisation patterns in the seven northern member states explain different preferences on the transfer of supervisory powers over less significant banks to the ECB. In particular, the reach of internationalisation into a national banking system – notably the extent to which even smaller banks were exposed to foreign banking operations – is shown to be the core factor explaining different national preferences on threshold. In the five countries with a large number of small and parochial alternative (cooperative and savings) banks, it is necessary to examine the system-specific structures of these banks to explain better the reach of internationalisation and national preferences on the threshold. Determined German opposition to ECB supervision of smaller alternative banks is juxtaposed with either less hostile or more positive support of at least four other countries despite the important presence of small alternative banks
The Political Economy of Competitiveness and Continuous Adjustment in EU Meta-Governance
Examining the potential impacts of climate change on international security: EU-Africa partnership on climate change
Reply to the EFSA (2016) on the relevance of recent publications (Hofmann et al. 2014, 2016) on environmental risk assessment and management of Bt-maize events (MON810, Bt11 and 1507)
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The nutritional significance of cheese in the UK diet
Cheese currently suffers from an adverse nutritional image largely due to a perceived association between saturated fatty acid, cholesterol and the salt content of cheese with cardiovascular disease. However, cheese is also a rich source of essential nutrients such as, proteins, lipids, vitamins and minerals that play an integral part of a healthy diet. This review outlines the composition, structure and physiological characteristics of the nutritionally significant components of cheese, whilst presenting some of the controversies that surround the role of cheese in dietary guidelines and the potential cheese has to improve health in the UK population
The new psychoactive substances 5-(2-aminopropyl)indole (5-IT) and 6-(2-aminopropyl)indole (6-IT) interact with monoamine transporters in brain tissue
In recent years, use of psychoactive synthetic stimulants has grown rapidly. 5-(2-Aminopropyl)indole (5-IT) is a synthetic drug associated with a number of fatalities, that appears to be one of the newest 3,4-methylenedioxymethamphetamine (MDMA) replacements. Here, the monoamine-releasing properties of 5-IT, its structural isomer 6-(2-aminopropyl)indole (6-IT), and MDMA were compared using in vitro release assays at transporters for dopamine (DAT), norepinephrine (NET), and serotonin (SERT) in rat brain synaptosomes. In vivo pharmacology was assessed by locomotor activity and a functional observational battery (FOB) in mice. 5-IT and 6-IT were potent substrates at DAT, NET, and SERT. In contrast with the non-selective releasing properties of MDMA, 5-IT displayed greater potency for release at DAT over SERT, while 6-IT displayed greater potency for release at SERT over DAT. 5-IT produced locomotor stimulation and typical stimulant effects in the FOB similar to those produced by MDMA. Conversely, 6-IT increased behaviors associated with 5-HT toxicity. 5-IT likely has high abuse potential, which may be somewhat diminished by its slow onset of in vivo effects, whereas 6-IT may have low abuse liability, but enhanced risk for adverse effects. Results indicate that subtle differences in the chemical structure of transporter ligands can have profound effects on biological activity. The potent monoamine-releasing actions of 5-IT, coupled with its known inhibition of MAO A, could underlie its dangerous effects when administered alone, and in combination with other monoaminergic drugs or medications. Consequently, 5-IT and related compounds may pose substantial risk for abuse and serious adverse effects in human users
Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries
<p>Abstract</p> <p>Background</p> <p>In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.</p> <p>Methods</p> <p>We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries.</p> <p>Results</p> <p>Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised.</p> <p>Conclusion</p> <p>The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.</p
Reducing Economic Imbalances in the Euro Area: Some Remarks on the Current Stability Programs, 2011–14
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