European Union initiatives

Along the same lines, a European Union initiative began last year (2006) to draw up common standards on HTA methods, which can increasingly make or break a new drug, even if it primarily addresses only the question of reimbursement by public health insurance. The hope is to bring greater rationality and speed to a process also known as the fourth hurdle for treatments to win approval, after safety, efficacy, and quality. 

In the case of Cd in drinking water the performance criteria are clearly speci-bed as 10 percent for both trueness and precision. Therefore, it is rather surprising to see PT providers stating assigned standard deviations of 5, 7, 10, or even 14 percent for Cd in water, in compliance with the WFD. This is because some PT providers only consider trueness, others, in turn, combine trueness and precision. Some consider precision properly, others take it as a direct estimate of the normalization factor. To improve such situations, the European Union initiated the CoEPT project to study the differences and similarities in the operation of PT schemes and the evaluation of PT results in view of implementing a harmonized approach to provide a basis for the comparability of the PT schemes operated on the market [70]. 

The directive will initially come into force on 29 November 1999. From that date until 28 May 2002 manufacturers have a choice between applying the pressure equipment directive or continuing with the application of the existing national legislation. From 29 May 2002 the pressure equipment directive will be obligatory throughout the European Union. 

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. 

For economies like the European economy, this is an excellent opportunity to have available and autonomous, as well as renewable energy source. The European Union strongly encourages this initiative, which allows the use of... 

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. 

The concept of a safety case comes from the requirements of the European Union/European Community (EU/EC) Seveso Directive (82/501/EC) and, in particular, regulations that the United Kingdom and other member states used to implement that directive. United Kingdom regulations (Control of Industrial Major Accident Hazards [CIMAH], 1984 replaced by Control of Major Accident Hazards Involving Dangerous Substances [COMAH] in 1999) require that major hazardous facilities produce a safety report or safety case.64 The requirement for a safety case is initiated by a list of chemicals and a class of flammables. Like the hazard analysis approach (Section 8.1.2), experts identify the reactive hazards of the process if analysis shows that the proposed process is safe, it may be excluded from additional regulatory requirements. 

The ITER R D project is the latest international research initiative on nuclear fusion for power generation. The ITER initiative has partners from the European Union, including Switzerland, Japan, Russia, China, South Korea, India and the United States. The project is expected to run for the next 30 years, of which 10 years will be needed for construction of the reactor in Cadarache, France, and 20 years for operation. The cost is approximately 10 billion and the first plasma operation is... 

There are several initiatives for the development and demonstration of CCS worldwide. For instance, the European Union has an ambition to deploy 10-12 full-scale CCS demonstration projects within Europe by 2015, testing various ways of integrating CCS in coal and gas-fired power generation it also aims for CCS to be commercially viable for all new fossil fuel power plants by 2020, with existing plants progressively retrofitted (EC, 2007). Other pilot and demonstration plants are planned in the United States, Australia and China.5... 

The initial HMF content in all honey samples was lower than the allowed maximum limit of 40 mg/kg as recommended by Turkish Alimentarus Codex [17], for honey in general. These results contradict the observation made by some authors that the types of honey produced in subtropical climates have high HMF exceeding 40 mg/kg [18]. However, the European Union council directive also allows for a maximum of 80 mg/kg for honey from tropical climates. The HMF level in honey is said to depend on the type of sugar present in honey and the fructose glucose ratio [19]. The HMF formation results from the acid catalyzed dehydration of hexose... 

The workshop took place at the Los Alixares Hotel, where 45 lectures were given by prominent members of the scientific community in addition, 49 posters were presented in two very animated sessions. The success of this workshop is due, without doubt, to the excellent tradition initiated at the previous workshops, organised by Prof. R. McWeeny in San Miniato, Pisa (Italy), 1996, and by Prof. S. Wilson in Oxford (United Kingdom), 1997. These workshops create occasions for meetings and discussions on the current state of the art, emerging methods and applications and new trends in this area of science. The three meetings were sponsored and partially supported by the European Union (EU) in the frame of the Cooperation in Science and Technology (COST) chemistry actions. 

The European Union s advisory Committee, the CPMP, was set up in 1975 under Directive 75/319. The first meeting was held on 26 November 1976 and Mr Leon Robert from Luxembourg was appointed its first Chairman. The Professional Head of the then UK Medicines Division, Dr EL Harris, who was also the UK Representative to CPMP, was elected a Deputy Chairman. Dr JP Griffin, initially his alternate but later the UK representative during 1977-84, was appointed Chairman of the CPMP Working Party on Safety. Dr NMG Dukes from the Dutch regulatory... 

Harmonisation, under ICH, involves the European Union, Japan and the United States of America, with the assistance initially of... 

The FDA has clarified the minimum requirements for an IND submission in three areas chemistry, toxicology reports (draft) and size (2-3 volumes, each 3" thick) in an attempt to relax current practices somewhat, to the level required for a UK CTX. However, full reports are to be provided within a short time after the initial drafts. (Conversely, however, information needed to conduct human studies in the European Union has increased, recently, with the implementation of the Clinical Trial Directive.)... 

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