نتایج جستجو برای: regulatory authority
تعداد نتایج: 209871 فیلتر نتایج به سال:
in this paper, it’s been tried to examine the legalframework of self-regulatory organizations in iran and the us’scapital markets and to clarify this matter in iran and the us (as theinnovator of self-regulation method in some way for setting rules andregulations), with emphasis on laws and practices. to achieve thispurpose, we analyzed this matter from the most important angles;therefore, in t...
The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to s...
BACKGROUND In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. METHODS We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clin...
The Constitutional amendment, made with the Law No. 6771 enacted on 21 January 2017, was approved by referendum held 16 April 2017. After amendment rationalized parliamentary system, which applied in Turkey, replaced “Turkish Presidential System”. One of most important changes is Decree power given to President. With this authority, executive body has been strengthened and attained “primary reg...
Background: Rapid pace of the construction projects have led to safety negligence on the part of the contractors causing higher numbers of accidents in construction industry. Thus, over 2200 legal provisions have been established for the prevention of accidents on construction sites. Not only contractors are unable to implement all provisions, but also it is hard for regulatory bodies to implem...
BACKGROUND This article seeks to identify the role of databases in health policy. Access to information and communication technologies has changed traditional relationships between the state and professionals, creating new systems of surveillance and control. As a result, databases may have a profound effect on controlling clinical practice. METHODS We conducted three case studies to reconstr...
Sinovac Biotech started to develop prototype pandemic influenza H5N1 vaccines in March 2004. On 2 April 2008, Sinovac's inactivated, aluminium-adjuvanted, whole-virion prototype pandemic influenza A (H5N1) vaccine (PanFlu) was granted production licensure by the China regulatory authority State Food and Drug Administration. The whole-virion H5N1 vaccine was manufactured in embryonated hens' egg...
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