• Title/Summary/Keyword: Regulatory decision

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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.

A Study on the Commercial Aircraft Pilot's Go -around Decision Making (민간항공 조종사의 Go-around 의사결정에 관한 연구 - 조절초점을 중심으로)

  • Hwang, Hyoe-Jung;Kim, Chun-Yong;Park, Su-Ae
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.17 no.3
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    • pp.61-69
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    • 2009
  • This research examined the influence of status and regulatory focus on go-around decision making. The result showed that there was no difference between captains and first offers on the go-around decision making about various landing situations. But there was significant relationships between regulatory focus and go-around decision making. Prevention focus was positively related with uncertain situation, and runway situation. Promotion focus has positive relationship with deficiency situation but has negartive relationship with runway situation.

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Development of a regulatory framework for risk-informed decision making

  • Jang, Dong Ju;Shim, Hyung Jin
    • Nuclear Engineering and Technology
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    • v.52 no.1
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    • pp.69-77
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    • 2020
  • After the Fukushima Daiichi accidents, public concerns on nuclear safety and the corresponding burden of nuclear power plant licensees are increasing. In order to secure public trust and enhance the rationality of current safety regulation, we develop a risk-informed decision making (RIDM) framework for the Korean regulatory body. By analyzing all the regulatory activities for nuclear power plants in Korea, eight action items are selected for RIDM implementation, with appropriate procedures developed for each. For two items in particular - the accident sequence precursor analysis (ASPA) and the significance determination process (SDP) - two customized risk evaluation software has been developed for field inspectors and probabilistic safety assessment experts, respectively. The effectiveness of the proposed RIDM framework is demonstrated by applying the ASPA procedure to 35 unplanned scrams and the SDP to 24 findings from periodic inspections.

Regulatory Aspect of Risk Assessment and Management

  • Lee, Hyomin;EunkyungYoon;Jeeyeun Han
    • Toxicological Research
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    • v.17
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    • pp.17-24
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    • 2001
  • Risk assessment is useful tool making good decisions on the risks of certain hazardous com-pound and suggests safe margin through scientific process using toxicological data, statistical tool, exposure value and relevant variants. The goal of risk management is to protect the public health from hazardous compound based on result of risk assessment having reality. For the suggestion of exact man-aging information, risk assessment must be designed to represent a "plausible estimate" of the exposure to the individuals and to minimize uncertainty. Risk assessment methodology and knowledge are expected to change more rapidly than before and up-to-date methodology should be applied in regulatory aspects through the Agency. For the useful application of risk assessment, the communication between the risk assessor and the risk manager is needed before the initiation of the risk assessment and upon its completion. Generally, the risk assessment itself as a practical tool in the regulatory decision making process would be regarded with social economic impact.ic impact.

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NUCLEAR REGULATORY RESEARCH IN KOREA: ACHIEVEMENTS AND FUTURE DIRECTION

  • Ryu, Yong-Ho
    • Nuclear Engineering and Technology
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    • v.41 no.4
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    • pp.403-412
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    • 2009
  • For efficient and effective nuclear regulation, regulatory organizations must establish consistent and rigorous regulatory positions on safety matters. These positions should be based on high technical expertise and relevant ordinances, standards, and guidelines reflecting policy changes governing nuclear regulations. The Korea Institute of Nuclear Safety, a regulatory expert organization in Korea, has developed regulatory requirements, guidelines and analytical tools that provide regulatory technical bases for ensuring nuclear safety. The nuclear regulatory research also contributes to regulatory decision making by providing resolution for current and future safety issues. In this article, we introduce nuclear regulatory research and its main achievements in the past 10 years. Also, suggested here are future directions of nuclear regulatory research.

Evidence-Based Benefit-Risk Assessment of Medication (근거에 기반한 의약품의 유익성-위해성 평가)

  • Lee, Eui-Kyung
    • The Journal of Health Technology Assessment
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    • v.1 no.1
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    • pp.22-26
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    • 2013
  • Objectives: Balancing benefits and risks through the drug life cycle has been discussed for many decades. The objective of this study was to review the processes and tools currently proposed for benefit-risk assessment of medicinal drugs. It aimed to establish scientific and efficient drug safety management system based on the synthetic analysis of benefit-risk evidence. Methods: We conducted a review of exiting literatures published by regulatory agencies or initiatives. Not only quantitative methodologies but also qualitative method were compared to understand their key characteristics for the benefit and risk assessment of drugs. Results: Recently, benefit-risk assessments have more structured approaches to decision making as part of regulatory science. Regulatory agencies such as European Medicines Agency, FDA have prepared plans to apply benefit-risk assessment to regulatory decision making. Also many initiatives such as IMI (Innovative Medicine Initiative) have conducted research and published reports about benefit-risk assessment. For benefit-risk assessment, four kinds of methods are necessary. Frameworks such as BRAT (Benefit Risk Action Team) framework, PrOACT-URL provide guidance for the whole process of decision-making. Metrics are measurements of risk benefit. The estimation techniques are methods to synthesis and combine evidences from various sources. The utility survey techniques are necessary to explicit preferences of various outcome from stakeholders. Conclusion: There is the lack of widely accepted, validated model for benefit-risk assessment. Nor there is an agreement among academia, industry, and government on methods for the quantitative valuation. It is also limited by available evidence and underlying assumptions. Nevertheless, benefit-risk assessment is fundamental to improve transparency, consistency and predictability for decision making through the structured systematic approaches.

ISSUES IN FORMULATING PERFORMANCE-BASED APPROACHES TO REGULATORY OVERSIGHT OF NUCLEAR POWER PLANTS

  • YOUNGBLOOD R. W.;KIM I. S.
    • Nuclear Engineering and Technology
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    • v.37 no.3
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    • pp.231-244
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    • 2005
  • In recent decades, significant effort has led to risk-informed improvements to regulation. Performance-based approaches also promise significant gains in efficiency (level of safety versus effort). However, significant work remains to be done before performance-based approaches realize their full potential in regulation of nuclear power plants. This paper reviews key concepts related to performance-based regulation, discusses some applications of performance-based approaches, and identifies issues that still need to be addressed. Realistic, experience-based models of licensee performance are still lacking; this makes it difficult to assess the prospective effectiveness of any given regulatory approach, in light of the performance issues that it will actually face. Also, while 'compliance' is an intuitively straightforward concept to apply within a prescriptive implementation, its analog in a performance-based approach remains unclear. An overarching theme of the paper is that formal methods of decision analysis are very helpful in developing appropriate regulatory approaches, especially performance-based ones; this theme is illustrated at several points.

A preliminary Study on Regulatory Frameworks for Consumer Product Safty Policy (소비자상품안전을 위한 규제분석틀에 대한 기초연구)

  • 김용희
    • Journal of Families and Better Life
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    • v.7 no.2
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    • pp.213-223
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    • 1989
  • Decision frameworks for product safty policy are developed in theory and practice. Product characteristic approach and expected utility analysis are applied to situations involving risk and misinformation. Eight types of regulatory frameworks are explained and critiqued form practical purposes on behalf of consumer policy makers. Various international organizations and their roles are briefly reviewed.

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Molecular Genetics of Emericella nidulans Sexual Development

  • Han, Kap-Hoon
    • Mycobiology
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    • v.37 no.3
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    • pp.171-182
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    • 2009
  • Many aspergilli that belongs to ascomycetes have sexuality. In a homothallic or self-fertile fungus, a number of fruiting bodies or cleistothecia are formed in a thallus grown from a single haploid conidia or ascospores. Genome-sequencing project revealed that two mating genes (MAT) encoding the regulatory proteins that are necessary for controlling partner recognition in heterothallic fungi were conserved in most aspergilli. The MAT gene products in some self-fertile species were not required for recognition of mating partner at pheromone-signaling stage but required at later stages of sexual development. Various environmental factors such as nutritional status, culture conditions and several stresses, influence the decision or progression of sexual reproduction. A large number of genes are expected to be involved in sexual development of Emericella nidulans (anamorph: Aspergillus nidulans), a genetic and biological model organism in aspergilli. The sexual development process can be grouped into several development stages, including the decision of sexual reproductive cycle, mating process, growth of fruiting body, karyogamy followed by meiosis, and sporulation process. Complicated regulatory networks, such as signal transduction pathways and gene expression controls, may work in each stage and stage-to-stage linkages. In this review, the components joining in the regulatory pathways of sexual development, although they constitute only a small part of the whole regulatory networks, are briefly mentioned. Some of them control sexual development positively and some do negatively. Regarding the difficulties for studying sexual differentiation compare to asexual one, recent progresses in molecular genetics of E. nidulans enlarge the boundaries of understanding sexual development in the non-fertile species as well as in fertile fungi.

The Influence of Omni-channel Propensity and Regulatory Focus on Consideration Set Formation (옴니채널 성향, 조절초점과 고려상표군 형성에 관한 연구)

  • HAN, Sang-Seol
    • The Journal of Industrial Distribution & Business
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    • v.10 no.5
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    • pp.49-58
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    • 2019
  • Purpose - Consumer behaviors or decision-making process has been changing recently as the consumer environment, including mobile everyday life, has changed. In view of this changing consumer smart environment, this study aims to investigate structural relation about the influence omni-channel propensity and regulatory focus on consideration set formation. Research design, data, and methodology - In order to proceed with this study, we review previous studies and setting hypotheses. The hypothesis was verified through a survey that was conducted for university students with experience in purchasing in less than three months. With reference to previous studies, operational definition was made for the questionnaire design. From 2018 Nov. to 2019 Feb. Survey was conducted on the panel consumers who purchase item within that period. 315 collected survey data were used to verify hypotheses except the data that had incorrect values. This data were used for SPSS/AMOS for confirm hypothesis which developed by researcher. Results - The results of this study are as follows. First, Consumers were considering a more heterogeneous alternatives if they were more omni-channel propensity in the process of forming consideration set. Second, Consumers were more conscious of the price if they were more omni-channel propensity Third, Consumers were considering a more newness alternatives if they were more omni-channel propensity in the process of forming consideration set. Meanwhile, The results of the study on regulatory focus and consideration set relationships are as follows. Consumers were considering a more heterogeneous alternatives if they were more promotion focus tendency in the process of forming consideration set. Second, Prevention focus tendency were more conscious of the price in the process of considering alternatives. Third, Consumers were considering a more newness alternatives if they were more promotion focus tendency. Conclusions - Depending on the changing consumer environment, the omni-channel propensity was shown to influence the formation of the consideration set. Also, Regulatory focus of consumers significantly influence to formation of consideration set. this study also contributes to the development of the theory as well as the practical approach with understanding consumer decision process on smart(mobile) environment.