Role of the regulatory body

In the case of sophisticated HOP concepts it may be necessary for the plant/utility to provide the regulatory body s experts with theoretical training to enhance technical discussions. This is especially important if an HOP reference system is being applied and the nuclear power plant is not able to present all the details of the development of the reference HOP package. 

Some of the topics that should be discussed with the regulatory body are  

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The role of the regulatory body in relation to transport will normally include requirements relating to the approval of package designs, the approval... 

This section sets forth an EOP development plan that should be fulfilled before the start of the actual writing of any guidelines or plant specific procedures. It also contains a discussion of the role of the regulatory body and the required supporting role of the utility. The following sections provide guidance on how to produce a consistent package of technically correct plant specific EOPs. 

The role of the regulatory body in the review and approval (if required) of EOPs was discussed in Section 3.1.5. However, it should be repeated that early involvement and open discussions with the regulatory body from the beginning of the project will smooth the progress of the entire licensing process. Regulatory body approval is typically a sequential activity ... 

The extent of the authority of the regulatory inspectors to take on the spot enforcement actions shall be determined by the regulatory body. (Ref [1], para. 5.23.) The degree of authority given to an inspector may depend on the structure of the regulatory body and on the inspector s role and experience. 

The provisions to ensure the documented adequacy of the operation organization and the independent role of the regulatory control bodies. 

After the development of an extreme external event and after the operator has taken immediate action, a decision needs to be taken on restoring operation. Dedicated procedures are developed which set out the roles, responsibilities (which in some cases are subject to approval of the regulatory body) and a list of systems to be inspected prior to operation. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

The role of the CRC is identical to that of European or American counterparts, or may be of more complex nature because of the complicated Japanese GCP and medical system. Many professional bodies, some backed up by regulatory body and academia, provide training courses for CRCs and recent statistics showed the number of trainee has exceeded 5000 and activities of... 

There are also instances where businesses can be proactive in environmental stewardship despite an apparent loss in profits. In these situations, bnsinesses seemingly compromise their profits by voluntary adopting compliance strategies. These policies of self-regulation at times reach even beyond what is reconunended by the regulatory bodies. While what motivates such actions is not always clear, perhaps some of the following factors play a role in their decisions. 

Exchange of fluid between the various compartments of the body is constant and extensive. In health, balance is maintained through a number of regulatory mechanisms. Water secreted into the gastrointestinal tract each day, as saliva, gastric, pancreatic, and intestinal juice and bile, may amount to as much as 8000 ml. of this, all but 100 ml. is normally reabsorbed. The role of the kidney in the regulatory mechanism has already been mentioned. Hormones are also of great importance. 

A more direct role in developing safety standards and systems also means that the regulators roles of system approval and audit, accident investigation and instigating legal penalties become compromised if the regulatory body has been implicated in decisions that are found to be less than... 

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