Regulatory environment

The pressure equipment directive was adopted by the European Parliament and the European Council in May 1997. It harmonises the national laws of the 15 Member States of the European Union relating to equipment subject to the pressure risk. That directive is one of the series of technical harmonisation directives such as for machinery, medical devices, simple pressure vessels, gas appliances and so on, which were foreseen by the Communities programme for the elimination of technical barriers to trade. It therefore aims to ensure the free placing on the market and putting into service of the equipment concerned within the European Union and the European Economic Area. At the same time it permits a flexible regulatory environment, allowing European industry to develop new techniques increasing thereby its international competitiveness. 

The use of these techniques is an important element of industrial policy since they contribute to the creation of a business friendly regulatory environment allowing the combination of measures taken for internal organisational reasons and obligations of certification without lowering the level of safety to be achieved. Wlienever possible a choice between product control and quality assurance procedures is offered to manufacturers. 

Hazards and Operability (HAZOP) analysis is an accident detection and prevention technique used primarily by the chemical process industry (CPI) (Lees, 1980). Even though the CPI operates in a different regulatory environment from the commercial nuclear power industry, the goals of risk reduction while maintaining productivity are similar. 

James L. Regens, "The Regulatory Environment for Coal Development," in Costs of Coal Pollution Abatement Results of an International Symposium. Paris Organisation for Economic Cooperation and Development, 1983. 

These industries will be operating in a complex regulatory environment. They will require engineers with a broad perspective on economic and environmental policy. 

Regardless of the regulatory area, the overall expectation is that organizations have determined the risks associated with the computerized systems utilized in their regulatory environments and that they have documented evidence of their efforts to minimize those risks and meet regulatory requirements. 

SFE instrument development has greatly been stimulated by the desire of the Environmental Protection Agency (EPA) to replace many of their traditional liquid-solvent extraction methods by SFE with carbon dioxide. In the regulatory environment, EPA and FDA approved SFE and SFC applications are now becoming available. Yet, further development requires interlaboratory validation of methods. Several reviews describe analytical SFE applied to polymer additives [89,92,324]. 

Therefore, it is anticipated that chronic repression of muscle gene expression does not require chronic regulation by the parasite. Rather, this effect is expected to result from chronic suspension of infected cells in a non-Go/Gi gene regulatory environment. A simple hypothesis derived from known characteristics of skeletal muscle cells is that induction of cell cycle re-entry is sufficient to cause both chronic suspension in G2/M and repression of muscle gene expression. This possibility has implications for the number of regulatory points at which the parasite might influence the host cell and possible methods to screen for those products. 

The latest developments in the regulatory environment related to plasticised or flexible PVC used in medical devices, alternatives to conventional PVC plasticisers and alternatives to PVC as the polymeric material are described. An assessment of strengths and weaknesses of the options is also provided. 3 refs. 

The regulatory environment is changing in Victoria with introduction from March 2000 of the Major Hazard Facilities Regulations, based on the Seveso II Directives. These are expected to flow on to the other states considered in this chapter. The key requirement of these regulations is the preparation of a Safety Case, which must demonstrate, among other requirements, that the risk from the new plant has been reduced to as low as is reasonably practicable - ALARP . The plants will incorporate a number of design features intended to reduce the risk from the facilities and demonstrate compliance with this criterion. 

Legal and regulatory environment The operation of C02 capture, and of C02 storage in particular, on a large industrial scale is to be considered as a new industrial activity. So far,... 

Selection of approach or combination of approaches to LNAPL recovery and ultimately aquifer rehabilitation and restoration is dependent on numerous factors as discussed in the previous chapters. The case histories presented below reflect different remediation approaches and strategies in response to varying geologic and hydrogeologic conditions, site-specific constraints, and regulatory environment. A variety of LNAPL recovery systems are first discussed, including ... 

Lumley, C.E., General pharmacology, the international regulatory environment, and harmonization guidelines, Drug Dev. Res., 32, 223-232, 1994. 

The goal of this section was to outline current differences between the implementation of process analytics in the chemical and pharmaceutical industry, specifically in the areas of business model, technology and regulations. The reader of this chapter should be aware that this status quo is changing rapidly in the pharmaceutical industry due to a changing business cUmate, combined with a more technology-aware regulatory environment in the major pharmaceutical markets. The authors of this chapter would expect that future editions of this book would see major revisions to this comparison of the industries. 

Process monitoring and control of API production, sans the regulatory environment, is analogous to that within the chemical industry. Since the early 1990s, numerous papers have been published noting on-line specnoscopic techniques as applied to API reaction monitoring. A representation of some of these on-line specnoscopic reaction monitoring techniques will be provided herein with additional information discussed in Chapter 15. 

Lampkin, N., Foster, C., Padel, S. and P. Midmore (1999). The policy and regulatory environment for organic farming in Europe. Organic farming in Europe Economics and Policy, Volume 1. Universitat Hohenheim Stuttgart-Hohenheim. 

The most important of these is the regulatory environment in which the industry works. In a series of judgements resulting from isolated cases of poor laboratory practice the regulatory authorities of many countries, particularly the United States, have defined a strict code of practice for the industry to ensure that the highest standards of development and manufacture are observed by all... 

Finally, New Zealand s experience with DTCA is in some respects similar to that of the United States, but the self-regulatory environment in New Zealand that to this point has not required fair balance in advertisements as is required by the FDA in the United States has resulted in ads that compare favorably with the United States in terms of communicating benefits of drugs, but rather unfavorably when communicating risks and information on who should not be taking the medicines. Whether DTCA will continue or be banned in New Zealand is currently unclear. 

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