• Title, Summary, Keyword: regulatory

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How should the regulatory defaults be set?

  • Jang, Seung-Cheol
    • Nuclear Engineering and Technology
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    • v.50 no.7
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    • pp.1099-1105
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    • 2018
  • How to choose defaults in risk-informed regulations depends on the conservatism implicated in regulatory defaults. Without a universal agreement on the approaches dealing with the conservatism of defaults, however, the desirability of conservatism in regulatory risk analyses has long been controversial. The opponent views it as needlessly costly and irrational, and the proponent as a form of protection against possible omissions or underestimation of risks. Moreover, the inherent ambiguity of risk makes it difficult to set suitable defaults in terms of risk. This paper, the extension of the previous work [1], focuses on the effects of different levels of conservatism implicated in regulatory defaults on the estimates of risk. According to the postulated behaviors of regulated parties and the diversity of interests of regulators, in particular, various measures for evaluating the effect of conservatism in defaults are developed and their properties are explored. In addition, a simple decision model for setting regulatory defaults is formulated, based on the understanding of the effect of conservatism implicated in them. It can help decision makers evaluate the levels of safety likely to result from their regulatory policies.

Regulatory T Cells and Infectious Disease

  • Rouse, Barry T.;Sehrawat, Sharvan
    • IMMUNE NETWORK
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    • v.7 no.4
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    • pp.167-172
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    • 2007
  • Various cell types that express regulatory function may influence the pathogenesis of most and perhaps all infections. Some regulatory cells are present at the time of infection whereas others are induced or activated in response to infection. The actual mechanisms by which different types of infections signal regulatory cell responses remain poorly understood. However a most likely mechanism is the creation of a microenvironment that permits the conversion of conventional T cells into cells with the same antigen specificity that have regulatory function. Some possible means by which this can occur are discussed. The relationship between regulatory cells and infections is complex especially with chronic situations. The outcome can either be of benefit to the host or damage the disease control process or in rare instances appears to be a component of a finely balanced relationship between the host and the infecting agent. Manipulating the regulatory cell responses to achieve a favorable outcome of infection remains an unfulfilled objective of therapeutic immunology.

Calibrating Thresholds to Improve the Detection Accuracy of Putative Transcription Factor Binding Sites

  • Kim, Young-Jin;Ryu, Gil-Mi;Park, Chan;Kim, Kyu-Won;Oh, Berm-Seok;Kim, Young-Youl;Gu, Man-Bok
    • Genomics & Informatics
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    • v.5 no.4
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    • pp.143-151
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    • 2007
  • To understand the mechanism of transcriptional regulation, it is essential to detect promoters and regulatory elements. Various kinds of methods have been introduced to improve the prediction accuracy of regulatory elements. Since there are few experimentally validated regulatory elements, previous studies have used criteria based solely on the level of scores over background sequences. However, selecting the detection criteria for different prediction methods is not feasible. Here, we studied the calibration of thresholds to improve regulatory element prediction. We predicted a regulatory element using MATCH, which is a powerful tool for transcription factor binding site (TFBS) detection. To increase the prediction accuracy, we used a regulatory potential (RP) score measuring the similarity of patterns in alignments to those in known regulatory regions. Next, we calibrated the thresholds to find relevant scores, increasing the true positives while decreasing possible false positives. By applying various thresholds, we compared predicted regulatory elements with validated regulatory elements from the Open Regulatory Annotation (ORegAnno) database. The predicted regulators by the selected threshold were validated through enrichment analysis of muscle-specific gene sets from the Tissue-Specific Transcripts and Genes (T-STAG) database. We found 14 known muscle-specific regulators with a less than a 5% false discovery rate (FDR) in a single TFBS analysis, as well as known transcription factor combinations in our combinatorial TFBS analysis.

The Influence of the Suitability of the Chronic Regulatory Focus and the Advertising Message Type on the Evaluation of the Beauty Product (성향조절초점과 광고메시지유형의 적합성이 미용제품평가에 미치는 영향)

  • Ko, Sung-Hyun;Hwang, Sun-Jin
    • Journal of Fashion Business
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    • v.15 no.2
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    • pp.1-11
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    • 2011
  • The purpose of this study is to investigate the influence of the suitability of the chronic regulatory focus and the advertising message type on the evaluation of the beauty product. In addition, feeling right while and individual is reading an advertisement is measured to check the mechanism making the regulatory fit effect. The experimental design was designed with the mixed design of 2(chronic regulatory focus: promotion / prevention, between group) ${\times}$ 2(advertising message type: promotion /prevention, within a group). 100 female university student subjects in their twenties in Seoul and in the metropolitan area were asked to respond to questionnaires in the study. The reliability analysis, T-test, analysis of variance(ANOVA), and analysis of covariance (ANCOVA) on the collected data were done with SPSS WIN 12.0. The results of the study are as follows. First, the regulatory fit effect that when the individual chronic regulatory fit corresponds to the advertising message focus each other in the advertising of a new beauty product, the evaluation on the product is more positive could be checked. The promotion focus message of shampoo, the promotion focus group showed more positive response than the prevention focus group and as for the prevention focus message, the prevention focus group showed more positive results than the promotion focus group so that the effect of regulatory fit appeared. Second, when the regulatory fit effect appeared in the evaluation on the new beauty product, the fit effect on the individual chronic regulatory focus and on the advertising message focus also appeared in the measurement of feeling right. Hence, feeling right could be checked by using the mechanism of the regulatory fit effect.

A Study for the Effect of Regulatory Fit on Beauty Service and Product (미용서비스와 제품의 조절초점적합성 효과에 관한 연구)

  • Yeo, Jun-Sang;Ko, Sung-Hyun
    • Journal of Fashion Business
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    • v.14 no.4
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    • pp.1-9
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    • 2010
  • The study verified the regulatory fit effect of the message focus and propensity regulatory focus delivered in the sales promotion situation of beauty services and products on the basis of the self-regulatory focus theory being actively discussed in the consumer behavior area of marketing. As the result of ANOVA analysis on the experimental design 2 (chronic regulatory focus: promotion focus/prevention focus, between factor) ${\times}$ 2 (message regulatory focus: promotion focus/prevention focus, within factor), the promotion focus group showed more positive response to the promotion focus message(4.88) of beauty services than the prevention focus group(4.40) so that the effect of regulatory fit appeared(t=1.79, p<.1), but the regulatory fit effect didn't appear in the prevention focus message(t=.58, p>.1) so that the hypothesis was partially supported. However, as for the promotion focus message of beauty products, the promotion focus group(4.62) showed more positive response than the prevention focus group(4.16), and as for the prevention focus message, the prevention focus group(4.89) showed more positive results than the promotion focus group(4.33) so that the effect of regulatory fit appeared(t=2.07, p<.05). Therefore, the result of the study shows that as for the service consumers perceive high risk, the sales promotion activity of the prevention focus message can be effective for prevention focus consumers and for promotion focus consumers as well. Otherwise, it suggests the marketing approach that the consumer evaluation is more positive when the advertising message focus fit the consumer regulatory focus.

Current Uses and Research Activity Regarding Non-testing Methods Including (Q)SARs in Various Chemical Regulatory Programs (국외 화학물질 관리 제도 내에서의 (Q)SARs 및 비-시험 방법 사용과 관련 연구 현황)

  • Ha, Mi-Hee;Kim, Sang-Hun
    • Environmental health and toxicology
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    • v.24 no.3
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    • pp.261-270
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    • 2009
  • To make measurable regulatory decisions of chemicals, it is necessary to consider their effect on the human health and ecosystem. In principle, this is based on relevant toxicity studies conducted by accepted guidelines. However, current regulatory programs in various countries confront challenges related to risk assessment of large numbers of chemicals within the restricted resources and time. Therefore there is a need for more efficient approach to limit the number of tests to be conducted. This promotes the development of powerful nontesting methods (e.g. (Q)SARs) and permits to use the predicted data for regulatory purpose. In this article, current status of non-testing methods in various chemical regulatory programs was reviewed in terms of their application and research activity on them. Finally, their usefulness associated with development of domestic regulatory program was suggested.

A Comparative Analysis of Barriers for Korean Pharmaceutical Companies in Global Regulatory Affairs by Company Size (기업 규모별 의약품 해외 인허가 과정에서의 장애요인 비교분석)

  • Hong, Yoon-Na;Ha, Dong-Mun
    • The Korean Journal of Health Service Management
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    • v.14 no.1
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    • pp.55-65
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    • 2020
  • Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs. Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents' companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion. Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes. Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies' expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.

'Behind-the-Border' Regulatory Policies and Trade Agreements

  • Hoekman, Bernard
    • East Asian Economic Review
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    • v.22 no.3
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    • pp.243-273
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    • 2018
  • A consequence of global trade liberalization is that domestic regulatory policies have become a focal point for efforts to reduce the costs of engaging in cross-border production and exchange. This article discusses the general challenges of reducing trade frictions created by regulatory differences, focusing specifically on the role trade agreements might play in addressing regulatory spillovers. A case is made for a greater focus on plurilateral cooperation under the umbrella of the WTO.

PRA RESEARCH AND THE DEVELOPMENT OF RISK-INFORMED REGULATION AT THE U.S. NUCLEAR REGULATORY COMMISSION

  • Siu, Nathan;Collins, Dorothy
    • Nuclear Engineering and Technology
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    • v.40 no.5
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    • pp.349-364
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    • 2008
  • Over the years, probabilistic risk assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, human reliability analysis (HRA), and pressurized thermal shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities.