• Asia Marketing Journal
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• v.21 no.1
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• pp.89-112
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• 2019

To investigate the interplay between individual and collective self-regulations, the authors propose a dialectic process that describes the changes in the locus of self-regulations between individual self and collective self. The results from three studies display a strong support for the two sets of hypotheses drawn from the proposed process. Our findings demonstrate that consumers can move the locus of self-regulation from individual-self to collective-self when a social identity is activated (preliminary study and study1). Further examination of regulatory swing between individual and collective regulatory orientations revealed group identification as a key variable in determining the locus of self-regulation (study2). While a consumer with a high level of group identification changes her locus of self-regulation from an individual to a collective (a regulatory shift) and evaluated messages and products framed consistent with their group orientation, a consumer with low level of group identification maintains her locus of self-regulation in her personal level of self (a regulatory preservation) and evaluated messages and products framed consistent with their personal regulatory focus.

• Journal of Regulation Studies
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• v.27 no.2
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• pp.71-104
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• 2018

Regulatory agencies' response to resource constraints is an important issue in terms of regulatory effectiveness, but systematic research is lacking. As an effort to overcome this limitation, this study was to explore behaviors of regulatory agencies in response to resource constraints. Reviewing the precedent studies based on regulatory and organizational theories, the study suggested the potential behaviors of regulatory agencies under resource constraints: changes in regulatory processes, changes in enforcement methods, decoupling, and regulatory delegation and contracting-out. The study also discussed the realistic explanations of the response behaviors partly through the case of marine transportation regulation, and explained the problems that the regulatory agency's behaviors could bring about. Based on the findings, the study suggested that the regulatory framework should be designed to ensure the effectiveness of the regulatory system in consideration of the regulatory agencies' behaviors under resource constraints. The study is expected to contribute to developing a theoretical analysis framework ultimately for an empirical study in the future.

• 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.

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.207-224
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• 2005

The objective of this study was to explore the principles of SUPAC-SS and its regulatory application in handling postapproval changes to nonsterile semisolid dosage forms. The types of postapproval changes that SUPAC-SS described were modifications in formulation (components and composition), batch size, manufacturing equipment & process, and the site of manufacturing. SUPAC-SS defined the levels of postapproval changes and what chemistry, manufacturing, and control tests should be conducted for each change level. The guidance also specified several occasions the manufacturers should perform in vitro release test (Franz cell diffusion test) and/or in vivo bioequivalence test. Finally, SUPAC-SS classified appropriate filing forms to be used in supporting postapproval changes. It was crystal clear that SUPAC-SS helped maintain the safety and quality of approved semisolid dosage forms when they were subject to certain postapproval changes. The availability of SUPAC-SS made contributions to reducing regulatory burdens of the industry, as well as expediting the postapproval process of regulatory agencies. This study also shed light on the background of relevant pharmaceutical sciences that the SUPAC-SS guidance adopted. Finally, the KFDA and the industry were strongly urged to implant a similar guidance in handling postapproval changes to semisolid dosage forms available in the Korean marketplace.

• 대한예방의학회:학술대회논문집
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• 1994.02a
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• pp.23-56
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• 1994

Recent criticisms of the conduct and use of risk assessment by regulatory agencies have led to a wide range of proposed remedies, including changes in regulatory statutes and the development of new methods for assessing risk. The mandate to this Committee was more limited. Our objective was to examine whether alterations in institutional arrangements or procedures, particularly the organizational separation of risk assessment from regulatory decision-making and the use of uniform guidelines for inferring risk from available scientific information, can improve federal risk assessment activities. Before undertaking to determine whether organizational and procedural reforms could improve the performance and use of risk assessment in the federal government, the Committee examined the state of risk assessment and the regulatory environment in which it is performed. In this chapter, we define risk assessment and differentiate it from other elements in the regulatory process, analyze the types of judgments made in risk assessment, and examine its current government context. Because one chronic health hazard, cancer, was highlighted in the Committee's congressional mandate and has dominated public concern about public health risks in recent years, most of our report focuses on it. Furthermore, because activities in four agencies--the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the Consumer Product Safety Commission (CPSC)--have given rise to many of the proposals for changes in risk assessment practices, our review focuses on these four agencies. The conclusions of this report, although directed primarily at risk assessment of potential carcinogens as performed by these four agencies, may be applicable to other federal programs to reduce health risks.

• Proceedings of the Korean Society of Soil and Groundwater Environment Conference
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• 2001.04a
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• pp.206-209
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• 2001

This study presents the leaching characterization of heavy metals according to changes of pH by ANC test on slag produced in electric arc furnace, bottom ash produced in coal-fired plants and their recycling products. Availability test was performed to assess the fraction of the total concentration that under worst environmental conditions could become available for leaching. TCLP, KLT(Korea Leaching Test) and KLTS(Korea Leaching Test of Soil contamination) were carried out to compare the leaching capacity and to estimate the adequacy of regulatory leaching test. Results from regulatory leaching tests could be misleading because the variable ANC of wastes can lead to very different final leachate pHs. The final pH of the regulatory test is not the ambient pH in the disposal environment, the actual solubilities of contaminants in the field may be entirely different from those predicted by these regulatory tests. Leaching behaviour of by-products was changed by recycling processes, therefore acid neutralization capacity and availability of new products, not leaching concentration by one batch regulatory test, are necessary to determine the method of recycling.

• Nuclear Engineering and Technology
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• v.56 no.2
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• pp.426-436
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• 2024

Nuclear security has been emphasized to ensure the safety of the environment and humans, as well as to protect nuclear materials and facilities from malicious attacks. With increasing utilization of nuclear energy and emerging potential threats, there has been a renewed focus on nuclear security. Korea has made efforts to enhance the regulatory oversight processes, both for general and specific legislative systems. While Korea has demonstrated effective nuclear security activities, continuous efforts are necessary to maintain a high level of security and to improve regulatory efficiency in alignment with international standards. In this study, the comprehensive regulatory oversight framework for the security of Korean nuclear facilities has been investigated. For reference, the U.S. regulatory oversight frameworks for nuclear facilities, with a focus on nuclear security, and the motivations of changes in regulatory oversight framework have been identified. By comparing these regulatory programs and frameworks, insights and considerations for enhancing nuclear security regulations have been identified. A comprehensive security inspection program tailored for the Korean regulatory oversight framework has been proposed, and has been preliminarily applied to hypothetical conditions for further discussion.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.17 no.4
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• pp.1-16
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• 2022

This paper studies the impact of regulatory approaches on innovation and entrepreneurship. As technological progress and environmental changes avail new business opportunities to innovative startups, many governments find it difficult to regulate new and unprecedented businesses promoted by the innovative firms. In order to provide academic and practitional implications on the regulatory design with which to support innovation and entrepreneurship, this paper aims to review classical theories on the demand and supply of regulation as well as empirical research on the impact of regulation on market entry and incentives for innovation. Based on the findings, this paper discusses the recent controversies around the regulatory approaches on new businesses pursued by startups, which are as known as the "positive regulatory approach" vs. "negative regulatory approaches" among practitioners and policy makers in Korea. This paper claims that the Korean context provides an useful opportunity to investigate how the ongoing transition of the once "fast follower" economy into a pacesetter one changes the nature of businesses pursued by firms, investors, and related market players and, accordingly, calls for the changes in the way the government intervenes in markets to regulate businesses of firms. By doing so, this paper sheds light on the role of the government in establishing an entrepreneurial ecosystem where innovative ideas of startups can be tested and nurtured.

• Asian-Australasian Journal of Animal Sciences
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• v.16 no.11
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• pp.1690-1694
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• 2003

The large and rapid changes of glucose utilization in lactating mammary tissue in response to changes in nutritional state must be largely related by external signal of insulin. This also must be related with the quantity and composition of the diet in vivo. To characterize the mode of growth factors and gut regulatory peptides with insulin, in vitro experiment was conducted with HC11 cells. All the growth factor alone and the combinations of growth factors significantly (p<0.05) increased in glucose uptake. Insulin, EGF and IGF-1 exhibited a stimulation of glucose uptake for at least 24 h. Furthermore, the highest (p<0.05) synergistic effect was shown in EGF plus IGF-1 and the second synergistic effect in insulin plus EGF while no synergistic effect was found between insulin and IGF-1. However, the gut regulatory peptides neither potentiated nor inhibited the action of insulin on glucose uptake. Although growth factors did not modulates glucose uptake via increasing the rate of translation of the GLUT1 protein, RT-PCR analysis indicated that the growth factors significantly (p<0.05) increased the expression of GLUT1. The growth factors are therefore shown to be capable of modulating glucose uptake by transcription level with insulin in HC 11 cells.