European approach

As in Europe, the classification of devices plays a central role in the regulation of devices in the US. However, there are a number of differences compared to the European approach. First of all, responsibility for classification rests with the FDA rather than with the manufacturers. When the regulations were introduced, the FDA mandated expert advisory panels (classification panels) to consider the different types of device that existed on the market at that time. The FDA provided classification questionnaires to act as guidelines for the panels when assessing the devices. In determining the safety and effectiveness of a device for purposes of classification, the classification panels had to consider the intended user (not part of EU criteria), the... 

To complete the discussion regarding the American and European approaches to mentoring, we would like to introduce the terminology that shall from hereon be used to describe these North American mentoring will from now on be referred to as sponsorship mentoring, whilst European mentoring will be called developmental mentoring. 

Although the international aspects of TSCA will be addressed in detail by another speaker, I thought it appropriate to mention that CMA and industry are participating in the development of those issues raised by the various sections of TSCA. For instance, in the area of testing chemicals under Section 5, there are differences between the U.S. and the European approaches regarding when testing should be required, which I have already mentioned. 

David B. Kopel, former Manhattan assistant district attorney and firearms law expert. Kopel has written numerous pro-gun rights works including The Samurai, The Mountie, and the Cowboy, a cross-cultural analysis of gun control laws that concludes that the European approach to gun control... 

See von Lampe, K. Proposal for a common European approach to assess organised crime . European Union Specific Targeted Research Project. 

Charter of Vantaa (2000) Recommendations for a European approach in Preventive Conservation. Passed on the Vantaa-meeting. September, 21-22, 2000. 

There is a great need for a coherent European approach to design adequate early identification systems for any approaching risks. An effective system of interactive communication with consumers, risk assessors, and risk managers should be established. Food policy must aim at creating the conditions, in which consumers have good reason to feel confident about the food they eat. 

Samoli, E., Touloumi, G., Schwartz, J., Anderson, H.R., Schindler, C., Forsherg, B., Vigotti, A.M., Vonk, J., Kodnik, M., Skorkovsky, J., Katsouyanni, K. (2007). Short-term effects of carbon monoxide on mortality an analysis within the APHEA (Air Pollution and Health a European Approach) project. Environ. Health Perspect. 115 1578-83. 

Salminen, S., Laine, M., von Wright, A., Vuopio-Varkila, J., Korhonen, T., and Mattila-Sandholm, T. 1996. Development of selection criteria for probiotic strains to assess their potential in functional foods A Nordic and European approach. Biosci. Microflora 15, 61-67. 

Pont, D., Hugueny, B., Beier, U., Goffaux, D., Melcher, A., Noble, R. et al. (2006) Assessing the biotic integrity of rivers at the continental scale a European approach using fish assemblages. Journal of Applied Ecology, 43, pp. 70-80. 

Basically the European approach can be described as progress through continuous adaptation of its legislation to the state of the art achieved by the European motor industry. Conversely American Legislation had from the outset been shaped by political objectives such as Senator Musky s 1970 demand that vehicle emissions be reduced by 90% within ten years. 

Participatory approaches to standard setting. The European approach is also a product of a regulatory strategy for occupational risks in which an orientation... 

An alternative approach therefore would be one in which there was greater specialist support for employers, including those in small firms, who are significant users of hazardous chemicals. This would probably require the implementation of some elements of a more European approach to external prevention services. Such views were quite forcefully expressed during the consultation exercise on the new OEL Framework. As a former president of Institute of Occupational Hygienists (one of the professional bodies accrediting occupational hygienists in the UK) put it (Allen 2004 9) ... 

Europe has done much to reduce its emissions of pollutants that contribute to acid rain and European approaches to acid rain abatement and air quality control are being studied by other regions of the world where air pollution and acid rain have become major problems. Thus, for example, a RAINS-... 

In Chapter 2, Jeff Makholm, an internationally renowned expert and consultant on natural gas issues worldwide, provides a comprehensive comparison between the North American and European approach to... 

A price-based US approach would be incompatible with the current European approach, which emphasizes emissions certainty. A further impediment to linking may come from different policies in the USA and the EU on the quantities and types of offsets (e.g. from sinks) that may be used in each system. Finally, even if the USA does not adopt these cost-containment or offset policies, it is possible that targets and allowance prices could be significantly different in the two systems. Thus, it may not be advisable to link emissions trading systems when the key features that determine short-term policy goals (e.g. target stringency and cost-containment features) are not harmonized (see, e.g., Sterk et al., 2006 Mace et al., 2008). 

The APHEA (Air Pollution and Health—An European Approach) project studied air-pollution effects in 15 and later with the APHEA 2 project in 34 European cities (Katsouyanni et al. 1995, 1997, 2001). The NMMAPS (National Morbidity, Mortality, and Air Pollution Study) project in the United States focused on time-series analyses of PMio effects on mortality during 1987-1994 in the 90 largest US cities (Samet et al. 2000a, b, c), and in the 20 largest US cities in more detail (Dominici et al. 2000a, b). These data have been summarized in the US-EPA s particulate matter criteria document (US-EPA 2004) and in a met analysis carried out by a WHO-Europe task group (Anderson et al. 2004). 

Atkinson RW, Anderson HR, Sunyer J et al (2001) Acute effects of particulate air pollution on respiratory admissions results from APHEA 2 project. Air Pollution and Health a European Approach. Am J Respir Crit Care Med 164 1860-1866 Ayres JG, Borm P, Cassee FR et al (2008) Evaluating the toxicity of airborne particulate matter and nanopaiticles by measuring oxidative stress potential—a workshop report and consensus statement. Inhal Toxicol 20 75-99... 

The European approach to protect consumers was developed along with the desire to promote the free movement of goods within a single market, then in the Union. The resulting regulation is built around materials and their associated dies rather than around a single object to minimize the eventual contamination of food. There are some inconsistencies with this, which must be corrected in practice. Examples include ... 

It is normal (in the United Kingdom and Europe) to determine the chloride concentration as a percentage by mass of sample but to quote chloride concentrations in weight percent of cement so the cement content must be known or estimated (usually assumed to be 14%). This is not a very accurate procedure which is why in North America they quote chloride contents in pounds per cubic yard of concrete. The European approach has a better grounding in the mechanism of corrosion, while the North American approach is more accurate in practice, but slightly less informative. 

August , G. Accreditation of engineering programmes A Pan-European approach. 33rd SEFI annual conference, Ankara, Turkey, September 7-10, 2005. 

Wolny, W.W. 2004. European approach to development of new environmentally sustainable electroceramics. Ceramics International 30 pp 1079-1083. 

Archick, K., et al. (2006) European approaches to homeland security and counterrorism. 51, U.S. Congressional Research Service. 

The principle of Quality Management has evolved, which has assisted the work of the QP. The European approach in nominating an individual to be an independent arbiter of quality is also applied to Good Distribution Practices in which a Responsible Person (RP) is introduced in legislation for Pharmaceutical Wholesalers [2]. 

European approach is to improve transparency, recognition, and therefore the mobility in higher education systems by using the tools of Bologna Process. Bologna Process is simplified by the following figure. 

The EU and FDA approaches to a biomedical product classification have some differences. The European approach leaves some interpretation up to the manufacturer, who selects the classification based on the rules described in Directive 93/42/EEC and subsequent amendments, as well as a set of EU guidelines that help in the interpretation, but they do not have a binding nature. The FDA approach is more defined and provides a classification scheme that is more rigid but that probably guides the manufacturer more securely in the classification process. 

Risk assessment is the cornerstone of the European approach to prevent occupational accidents and ill health. If the risk assessment process—the start of the health and safety management approach— is not done well or not at all, the appropriate preventive measures are unlikely to be identified or put in place. 

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