Safety Regulatory Oversight

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

Regulatory oversight is an integral part of the pharmaceutical industry, in order to ensure safety, efficacy, purity, and consistency of drugs for human use. 

Other OECD activities in the environment, health, and safety areas are concerned with pesticides chemical accident prevention, preparation, and response pollutant release and transfer registers harmonization of regulatory oversight in biotechnology, and the safety of novel foods and feeds. These activities are closely connected with the work in the Chemicals Programme, and are carried out in cooperation with other parts of the OECD and other international organizations. 

The FDA and USDA provide widespread regulatory oversight in ensuring food safety (Donoghue, 2003). In the United States, the foods... 

Sources of Bias. Finally, the very data on which safety and effectiveness decisions are made, while voluminous and scrupulously cleaned, may be of questionable value owing to the very process by which investigators and subjects are selected (not randomly sampled) and the data are revised (not simply cleaned) to fit our preconceived data models. Regulatory oversight has focused not on the scientific validity of the sampling frame or the meaningfulness of the data, but rather on adherence to a set of technical procedures that may assure neither. These three points deserve clarification. 

BSEE administers the new regime s safety program. Its role defined by DOI is to process permits to drill as safely as possible, enforee safety and environmental regulations, provide sustained regulatory oversight that is focused on compliance by operators with all applicable environmental regulations, train inspectors, perform various shared responsibilities with BOEM and the CG, and implement... 

The case involved a complex sequence of events. Investigations pointed to many issues, including flawed operating procedures, driver error, a defective locomotive, poor track maintenance, weak regulatory oversight, and lack of safety redundancy. ... 

Because regulatory oversight alone will not be sufficient to ensure adequate safety, the oil and gas industry will need to take its own, unilateral steps to dramatically increase safety throughout the industry, including self-policing mechanisms that supplement governmental enforcement. 

While probabilistic assessment was mainly used in Germany in the frame of PSR in the past, PSA applications shall be further extended to regulatory oversight activities in the future. The above mentioned Safety Requirements define relative probabilistic criteria to be applied for plant or organizational modifications applied by the licensee or for evaluating events or phenomena which may have a non-negligible effect on PSA results. For these applications a short document is in preparation as well. 

While in Germany PSA was used in the past mainly in the frame of the ten years (Periodic) Safety Reviews, PSA as a supplementary analytical tool to be applied in the daily nuclear regulatory oversight in case of modifications by the licensee or for an assessment of those events or phenomena for which a significant influence on the results of the PSA results can be expected shall be further extended in the future. 

---