Regulatory Activity

There has been a tremendous increase in regulatory activities worldwide aimed at achieving safer manufacture, use, and disposal of chemicals, including colorants (380). Table 1 is a summary of important United States, European, and Japanese Environmental Legislation affecting workers, consumers, and the pubhc and environment (381). 

Directs national efforts to meet air quality goals, particularly for smog, air toxics, carbon monoxide, lead, particulate matter (soot and dust), sulfur dioxide, and nitrogen dioxide. The office is responsible for more than half of the guidance documents, regulations, and regulatory activities required by the Clean Air Act Amendments of1990. 

In the United States, as in many European countries, there is a level of awareness of process safety based on industry history and experience, public perception (as influenced by the news media), and regulatory activity. This level of awareness provides a foundation for the process safety management implementation processes. 

Adverse events need to be coded consistently with respect to letter case. Problems can occur when there is discordant coding using all capital letters, all lower-case letters, or combinations thereof, as computer software will interpret these capitalization variations as different events. Letter case sensitivity can be important when two or more words are used to describe an adverse event. For example, some databases utilizing the Medical Dictionary for Regulatory Activities (MedDRA) coding dictionary employ a coding system in which only the first letter of the first word of an adverse event is capitalized (e.g., Atrioventricular block complete ). Failing to adhere to uniform letter case conventions across the data can result in severe errors in data analysis. 

The value of all dmg regulatory activities depends on whether they produce the intended outcomes. Outcomes can be measured in terms of ... 

Because of its heavy reliance on aid for the funding of regulatory activities, the Ugandan DRA is faced with a serious problem of financial sustainability. The financial resources are not only beyond its own control, but also beyond the control of the Government itself When donors finally withdraw their funding, some of the DRA s activities may... 

Outcomes, on the other hand, are the final results obtained by carrying out the different regulatory activities and functions. 

The first three objectives relate to pharmaceutical products, and the fourth to pharmaceutical usage although, in most countries, promoting rational use of dmgs is not part of regulatory activities. In order to achieve the four objectives, the various pharmaceutical activities— manufacturing, importation, exportation, distribution... 

IRIS is a database of human health effects that may result from exposure to various substances found in the environment. IRIS was initially developed for EPA staff in response to a growing demand for consistent information on chemical substances for use in risk assessments, decision-making and regulatory activities. 

CMA), and the USDA are excellent sources of information relative to current regulatory activities which will impact both production agriculture and the setting of tolerances to ensure food safety. The purpose of this article is to summarize the key impacts of the 1996 OPPTS 860 Residue Chemistry Test Guideline series as they impact research associated with field production of RAC samples to be used in establishing safe tolerance limits for pesticides used in commercial agricultural production. 

Bruhl H, Cihak J, Schneider MA, et al. Dual role of CCR2 during initiation and progression of collagen-induced arthritis evidence for regulatory activity of CCR2+ T cells. J Immunol 2004 172(2) 890-898. 

Some Palmer amaranth samples prepared at SRRC were first extracted with hexane (HX), rather than PE. The organic solvent extracts were supplied for bioassay in the form of oils or solids remaining after solvent removal in vacuo. After each extraction step aliquots of the crude extracts from the roots, stems, or leaves (and thyrses) were evaluated for seed germination regulatory activity. 

Table I. Seed Species Used to Determine In Vitro Germination Regulatory Activity of Palmer Amaranth and Ragweed Extracts...

Able to produce their effects by altering the higher regulatory activity of the central nervous system. 

The Medical Dictionary for Regulatory Activities (MedDRA) is a creation of the International Conference on Harmonization, and it is used to categorize and code diseases, disorders, and adverse events. The five levels and associated codes to the MedDRA coding hierarchy are as follows ... 

Medical Dictionary for Regulatory Activities a creation of the International Conference on Harmonisation used to categorize and code diseases, disorders, and adverse events. 

Many companies have developed or purchased computer software for the purpose of storing stability data for a large number of studies. Examples of commercially available systems are SLIM [147] and Stability System [148]. These systems can perform other functions as well, including work scheduling, preparation of summaries of selected or all studies in the system, tabulation of data for individual studies, label printing, statistical analysis and plotting, and search capabilities. Such systems should be validated to keep pace with current regulatory activity [149],... 

Adverse events include those that may be attributable to the underlying disease. Figures in parentheses represent percentage. MedDRA = Medical Dictionary for Regulatory Activities (http // www.meddramsso.com/NewWeb2003/medra overview/index. htm) NOS = not otherwise specified. 

Rao, D.R. and G. Paul. 1988. Growth regulatory activity of dimilin against Mesocyclops thermocyclopoides. Current Sci. 57 399-400. 

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