scholarly journals Extended use or reuse of N95 respirators during COVID-19 pandemic: An overview of national regulatory authority recommendations

2020 ◽  
Vol 41 (11) ◽  
pp. 1364-1366 ◽  
Author(s):  
Leticia Mitiko Kobayashi ◽  
Bianca Ramos Marins ◽  
Patrícia Cristina dos Santos Costa ◽  
Hugo Perazzo ◽  
Rodolfo Castro
Keyword(s):  
Regulatory Authority ◽  
National Regulatory Authority ◽  
N95 Respirators

The Use of Placebos in Clinical Trials for Acute Schizophrenia

1995 ◽  
Vol 40 (4) ◽  
pp. 171-176 ◽  
Author(s):  
Donald Addington
Keyword(s):  
Regulatory Authority ◽  
Literature Search ◽  
Drug Evaluation ◽  
Chronic Schizophrenia ◽  
Antipsychotic Medications ◽  
Ethical Justification ◽  
Official Position ◽  
Acute Relapse ◽  
National Regulatory Authority ◽  
Canadian Studies

This review examines the scientific and ethical justification for the use of randomized concurrent placebo-controlled trials in the treatment of acute relapse in chronic, schizophrenia. A literature search was conducted, and the national regulatory authority was consulted. Many placebo-controlled studies of acute or chronic schizophrenia are being published and it is the official position of both the Canadian and US regulatory authorities that such studies are required for both scientific and ethical reasons. The specific strengths and limitations of placebo-controlled studies are reviewed. Examples, drawn from Canadian studies, are presented to illustrate their benefits. It is concluded that the use of placebos in the particular situation of acute or chronic schizophrenia is ethically and scientifically justified. It forms an essential component of a comprehensive drug evaluation for new antipsychotic medications.

Role of the national regulatory authority for vaccines

2017 ◽  
Vol 22 (3) ◽  
pp. 128-137 ◽  
Author(s):  
Norman W. Baylor
Keyword(s):  
Regulatory Authority ◽  
Developed Countries ◽  
Pharmaceutical Products ◽  
World Health ◽  
Expert Committee ◽  
Content Type ◽  
Mortality And Morbidity ◽  
Expert Review ◽  
Regulatory Authorities ◽  
National Regulatory Authority

Purpose Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue. Design/methodology/approach Expert review. Findings Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA. Originality/value Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.

scholarly journals Building competence in radiation and nuclear safety through education and training – the approach of a national regulatory authority

2015 ◽  
Vol 50 (1) ◽  
pp. 59-64
Author(s):  
K.L. Karfopoulos ◽  
E. Carinou ◽  
V. Kamenopoulou ◽  
P. Dimitriou ◽  
Ch. Housiadas
Keyword(s):  
Regulatory Authority ◽  
Education And Training ◽  
Nuclear Safety ◽  
National Regulatory Authority ◽  
And Training

“Beyond Mobistar” – Assessment of the Deterrent Effect of Direct Charges to Telephone Subscribers under Article 30(2) of the Universal Service Directive

2011 ◽  
Vol 2 (2) ◽  
pp. 279-282
Author(s):  
Markus Berliner
Keyword(s):  
Regulatory Authority ◽  
Maximum Amount ◽  
Mobile Telephone ◽  
Universal Service ◽  
Deterrent Effect ◽  
Electronic Communications ◽  
Communications Networks ◽  
National Regulatory Authority ◽  
Number Portability ◽  
A Charge

Article 30(2) of Directive 2002/22/EC of the European Parliament and of the Council of 7 March 2002 on universal service and users’ rights relating to electronic communications networks and services (Universal Service Directive [USD]) is to be interpreted as obliging the national regulatory authority to take account of the costs incurred by mobile telephone network operators in implementing the number portability service when it assesses whether the direct charge to subscribers for the use of that service is a disincentive. However, it retains the power to fix the maximum amount of that charge levied by operators at a level below the costs incurred by them, when a charge calculated only on the basis of those costs is liable to dissuade users from making use of the portability facility (official headnote).

scholarly journals Unprofessional conduct by nurses: A document analysis of disciplinary decisions

2021 ◽  
pp. 096973302110152
Author(s):  
Oili Papinaho ◽  
Arja Häggman-Laitila ◽  
Mari Kangasniemi
Keyword(s):  
Registered Nurses ◽  
Regulatory Authority ◽  
Work Performance ◽  
Document Analysis ◽  
Criminal History ◽  
Ability To Work ◽  
National Regulatory Authority ◽  
The Mean ◽  
Nursing Guidelines ◽  
Quantitative Statistics

Background: A small minority of nurses are investigated when they fail to meet the required professional standards. Unprofessional conduct does not just affect the nurse but also patients, colleagues and managers. However, it has not been clearly defined. Objective: The objective was to identify unprofessional conduct by registered nurses by examining disciplinary decisions by a national regulator. Design: A retrospective document analysis. Data and research context: Disciplinary decisions delivered to 204 registered nurses by the Finnish national regulatory authority from 2007 to 2016. The data were analysed with quantitative statistics. Ethical consideration: The study received permission from the Finnish National Supervisory Authority for Welfare and Health and used confidential documents that were supplied on the basis of complete anonymity and confidentiality. Findings: The mean age of the registered nurses who were disciplined was 44 years and 81% were female. Two-thirds had worked for their employer for 5 years or less, 53% had two or more employers and 18% had a criminal history. All the decisions included a primary reason for why the nurses were investigated, but there were also 479 coexisting reasons. In most cases, unprofessional conduct was connected to substance abuse (96%). In addition, stealing of medicine, a decreased ability to work and neglect of nursing guidelines were reported. Discussion: We found that the nurses were investigated for unprofessional conduct for complex combinations of primary and coexisting reasons. Our study highlighted that more attention needs to be paid to the key markers for unprofessional conduct. Conclusion: Unprofessional conduct is a complex phenomenon that is connected to nurses’ individual and working backgrounds and has an impact on their work performance. More research is needed to identify how nursing communities can detect, manage and limit the serious effects and consequences of unprofessional conduct.

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