Regulatory executives

Similarly, clinical trial strategy teams bring together CRSs with statisticians, data managers, regulatory executives, pharmaceutical physicians and marketing managers to discuss the clinical data that is needed, and the time-scales and costs, to achieve specific commercial objectives. 

The regulatory department may be part of the medical department or the research function, or report directly to the head of the company. Wherever it is placed, the role of regulatory executive is crucial to the success of the company. The regulatory executive defines the pharmaceutical, toxicological... 

Seeing the success of the UNAMAP BBS, EPA s Office of Air Quality Planning and Standards started a BBS for information on regulatory models in June 1989. This has expanded to a BBS called TTN, Technology Transfer Network. This BBS, in Durham, NC, is reached on (919) 541-5742 and the system operator on (919) 541-5384. A part of this BBS called SCRAM, Support Center for Regulatory Air Models, contains model FORTRAN codes, model executable codes for use on personal computers, meteorological data, and in some cases model user s guides. Much of the information is downloaded in "packed" form, and software to unpack the files must also be downloaded from the bulletin board. 

ISCST3 - Industrial Source Complex - Short Term This model is used in more detailed studies of maximum air quality impacts (Phase 3 - Refined Modeling Analysis). The purpose is to compute short term concentration or deposition values, from multiple sources, on specified locations (i.e., receptors). To download the file, click the filename. This is the latest version of the regulatory model ISCST3 (00101) which was released by U.S. EPA on April 27, 2000. The file ISCST.ZIP is 1.60 MB (Executable, Source, Test Cases). You can also download the ISCST3 model evaluation references. 

Models are available, individually, from tlie National Teclinical Information Service (NTIS) on microcomputer disks. Regulatory and Air Quality models will also be available as a package. Most of the disks must be transported (uploaded) to IBM 3090 niacliines however, some models do have PC executable code. 

Regulatory and advisory bodies publish methods for ambient air analysis such as those issued by the British Standards Inshtute and the US Environment Protechon Agency (Tables 10.24 and 10.25, respectively). Methods for assessment of workplace air are published by the Health and Safety Executive. Some of these are generic methods (Table 10.26) whilst others are compound specihc (Table 10.27). Examples of other official methods for moihtoring workplace air quality are those published by the British Standards Inshtute (Table 10.28), and the US Nahonal Institute of Occupational Safety and Health (Table 10.29). Table 10.30 provides addihonal guidance on analytical techniques for a selection of substances. 

The existence of a regulatory function in a country does not necessarily mean that the function covers the entire range of pharmaceutical products and/or activities. Nor does it mean that the control described in the country s legislation is always fully executed in practice. 

Legal status of regulatory authority Executive dept. Executive dept. Council Exec. agency Executive dept. Board Executive dept. Statutory authority Executive dept. Statutory authority... 

Alternatively, the regulatory authority may be a department or division of the executive branch. Authorities of this type are headed by a director, who is appointed by the head of the executive branch or ministry. This structural arrangement allows the head of the executive branch/ministry greater influence or control over the decision-making and enforcement activities of a regulatory authority (22). 

Analysis of the study reports shows that the MEB in the Netherlands and the dmg regulatory authorities of Uganda and Zimbabwe are organized in a board format. The MEB, which is the main DRA in the Netherlands, is organized as a board whose members are appointed directly by the Crown. This appointment procedure makes it relatively free from the influence of other Government bodies. The MCAZ and the Ugandan NDA are also established as statutory authorities, with executive committees plus some specialized advisory committees. Although board members are appointed by the Minister of Health, their independence is established by statute. 

In Cuba, Tunisia and Venezuela, the dmg regulatory authorities are departments within the executive branch, the Ministry of Health, which possesses decision-making powers regarding dmg regulation. Expert committees are consulted on technical issues, rather than as decision-making bodies. Under this stmcture, the superior agency (the Ministry of Health) theoretically has the authority to alter a decision if it chooses to do so. 

Many and varied field techniques involved in the planning, execution, and direction of the field portion of worker exposure and re-entry studies have been considered. Suffice it to say that there are many ways to perform such studies, and the important thing to remember is that good scientific thought and planning will produce an excellent study. The scientific validity of such studies should rest on the basic principles of science. There are various guidelines and protocols which may be followed for regulatory... 

College of Health Professions Medical University of South Carolina Charleston, South Carolina Wesley G. Byerly, PharmD Executive Director for Research Regulatory Affairs Keely L. Cook, MPAS, PA-C Assistant Professor Doisy College of Health Sciences Saint Louis University St. Louis, Missouri... 

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