Regulatory Oversight

Convention on International Civil Aviation, supra, note 3. 

Management System as a businesslike approach to safety. An SMS is a systematic, explicit and comprehensive process for the management of safety risks that integrates operations and technical systems with financial and human resource management, for all activities related to an air operator as an approved maintenance organization s certificate holder.  

Abeyratne R (2007) State responsibility for safety management systems. J Aviat Manag 2 7-13 Abeyratne R (2007) Air Law and Policy. PublishAmerica, Baltimore 

Abeyratne R (2009a) Regulating unmanned aerial vehicles- issues and challenges. Eur Transport Law XLIV(5) 503-520 

Abeyratne R (2009b) The role of ICAO in implementing the safety roadmap. Eur Transport Law 

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The use of the risk-based decision making process allows for efficient allocation of limited resources, such as time, money, regulatory oversight, and qualified professionals. Advantages of using tliis process include ... 

Figure 2.8 Milestones in the development of regulatory oversight of drugs and devices in the USA.

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. 

The appropriate signatory to meet compliance requirements would be the director of quality control. Additional signatures from quality assurance are not necessarily required but would provide an opportunity for regulatory oversight. 

It can be manufactured in sufficiently large quantities by processes that can comply with all necessary regulatory oversight and that are financially viable for the sponsor. 

One nice feature of CL detectors is that they do not use a radioactive ionization source [29] and thus avoid some of the paperwork and regulatory oversight that may be associated with ion mobility spectrometer detectors. 

TABLE 1. Implementation and regulatory oversight of the spent fuel disposal program... 

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