Regulatory authorities independence

Corporate environmentalism is an evolving concept for environmental protection. In this case, business takes a pro-active stance independent of regulatory authorities. This can be in recognition of social responsibilities, but is more successful when compelled by competition in the market place. Thus, a hrm can conscientiously target environmentally aware consumers (through marketing environmentally friendly products or processes) or can be better placed for hnancial support from ethical investment funding bodies. 

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 addition to controlling information used for promotional and advertising purposes, dmg regulatory authorities in the majority of the countries also provide independent dmg information. This is hue of Cypms, Estonia, Malaysia, the Netherlands, Tunisia, Venezuela and Zimbabwe. Dmg information is mainly disseminated via regular bulletins. Other bodies besides the DRA also provide independent information about dmgs. 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

The ICF consists of two documents - the information sheet and the actual consent form. They must be considered as a pair of documents, not separate entities. Normally, a core ICF should be present in the appendices. The core ICF may need modifications to comply with local regulations. It is the responsibility of the sponsor/ institution, or in an independent study the investigator, to prepare an ICF that meets the requirements of ICH CCP or any additional requirements of the local regulatory authority, and is only used after it has been approved by the relevant I EC. 

Every country needs an authoritative, independent, competent and reliable system for evaluating adverse reactions to drugs and vaccines - a system that is linked with and provides support for the national drug regulatory authority (NRA) and for the national ministry of health. More than 80 countries... 

Reports and guidelines from drug regulatory authorities, health authorities or other independent institutions, like the Cochrane Collaboration, are valuable in many aspects. Drug regulatory authorities have, in the process of drug... 

The evaluation as a food additive or GRAS substance may provide relevant safety information to support the use of a proposed new excipient in a drug product. The evaluation of a new excipient that is to be used orally as a food additive and that is evaluated independent of the drug product approval process may serve as a review of the safety of the excipient by a recognized regulatory authority. 

We certainly hope that this book will encourage regulatory authorities to develop new regulatory processes for independent review and use of excipients. The availability of independent review will encourage innovation and development of commercially viable new excipients. Ultimately, all this should help quickly develop lifesaving drug delivery systems benefiting humans. 

If any one of the three assessment methods demonstrate that water-quality standards are not attained, it is EPA s policy that appropriate action should be taken to achieve attainment, including use of regulatory authority (the independent applicability policy). 

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