Europe standards defined

The preclinical testing itself is performed by specialists in this field and is often outsourced to Contract Research Organization that should perform the studies conforming to the standards of Good Laboratory Practice (GLP in Europe as defined by the OECD). 

The terms compostable and compostability are not defined in many dictionaries, but can be found in technical norms, particularly in Europe (NF EN 13432). This world recognized European standard defines the conditions that must be satisfied for a packaging (according to the European directive 94/62/CE) to be declared compostable under industrial conditions. 

The new Biocidal Products Directive is examined, which closes the gap in European legislation for products such as disinfectants and anti-foulants where there has not, until now, been a Europe-wide standard. The basic goals of the directive are to simplify and harmonise Europe s regulatory framework for biocides, and to remove trade barriers within the EU, and to improve the protection of both human health and the environment. The new directive must be enforced as national legislation in all member countries by 14 May 2000. Details are given of products defined within the directive, and ways in which the directive will be put into practice in the UK are discussed. The implications of the legislation on the industry in terms of time and money spent on testing for each active substance involved are examined. 

Ten years later, a pair of Directives extended the provisions of 65/65. Directive 75/318 defined testing and protocol standards, while Directive 75/319 introduced the Committee for Proprietary Medicinal Products (CPMP) and what is now known as the mutual recognition procedure (MRP) for MA (see below). Nine years later, the structure of the CPMP was adjusted by Regulation 726/2004, and now forms the CHMP (see below). These three fundamental Directives represent the basis of pharmaceutical regulation that is common to the whole of Europe the creation of the EMEA in 1995 (by Regulation 2309/93, two years earlier) provided the machinery that implements these Directives. 

There has been much published on the incidence, detection and prosecution of publication fraud, rather less on fraud and misconduct in clinical research, but we should be equally concerned about research fraud. The Consensus Conference on Misconduct in Biomedical Research convened by the Faculty of Pharmaceutical Medicine and the Royal College of Physicians of Edinburgh in 1999 defined research misconduct as behavior by a researcher, intentional or not, that falls short of good ethical and scientific standards . Frank Wells, co-founder of MedicoLegal Investigations Ltd., the only specialist research fraud investigation company in Europe, prefers the generation of false data with the intention to deceive . 

In common with other power system equipment, motors need to be derated to suit a high ambient temperature. Equipment that is manufactured in America, UK and Europe is usually based on a maximum design temperature of 40°C. For higher ambient temperatures, e.g. 50°C as found in the Middle East and Ear East, the continuous duty output power and supply current would need to be reduced. The continuous duty is that as defined as type SI in IEC60034 part 1. International standards recommend performance and design criteria suitable for 40°C. Although most of these standard requirements will apply to ambient temperatures above 40°C there may be some addition restrictions to apply. In particular aspects of full-load current, duty, radiation of heat loss and outer surface temperature will need to be considered, see for example IEC60034 part 1 clauses 11 and... 

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