• Asia Marketing Journal
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• 제21권1호
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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.

• 규제연구
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• 제27권2호
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• pp.71-104
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• 2018

자원제약에 대한 규제기관의 대응행태는 규제의 효과성 측면에서 중요한 이슈임에도 불구하고 체계적인 연구가 부족하다. 본 연구는 이러한 한계를 벗어나기 위한 노력으로서 규제자원이 제약된 상황에 대응한 규제기관의 행태를 시론적으로 제시하는 데에 주된 목적을 두었다. 구체적으로, 규제이론과 조직이론에 기반한 선행연구를 비판적으로 검토하여 자원이 부족한 상태에서 나타날 가능성이 있는 규제기관의 행태(규제과정상의 변화, 집행방식의 변화, 비동조화, 규제위임과 민간위탁)를 제시하였다. 이 과정에서 주로 해운규제분야 사례들을 통해, 도출한 대응행태의 현실적인 설명가능성을 살펴보았으며, 자원제약에 대응한 규제기관의 행태가 가져올 수 있는 문제점에 대해서도 논의하였다. 연구결과를 토대로 규제자원의 부족 상태에서 규제기관이 보일 행태를 고려하여 규제의 효과성을 보다 담보할 수 있는 규제체계를 설계할 필요가 있다는 시사점을 제시하였다. 본 연구는 향후 실제 자원제약을 받고 있는 우리나라 규제기관들의 행태를 실증적으로 분석할 수 있는 이론적 분석틀을 마련하는 데에 도움을 주리라 기대한다.

• Nuclear Engineering and Technology
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• 제41권4호
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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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• 제35권3호
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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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• 대한예방의학회 1994년도 교수 연수회(환경)
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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.

• 한국지하수토양환경학회:학술대회논문집
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• 한국지하수토양환경학회 2001년도 총회 및 춘계학술발표회
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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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• 제56권2호
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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.

• 대한예방한의학회지
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• 제28권1호
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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.

• 벤처창업연구
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• 제17권4호
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• pp.1-16
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• 2022

이 논문은 규제방식이 창업과 혁신에 미치는 영향에 대해 연구한다. 규제는 정부가 강제성을 지닌 법적 조치로 시장 행위를 제한하거나 개입하는 것을 의미한다. 규제를 바라보는 관점으로는 규제는 정부가 공익을 저해하는 시장 주체의 행위를 시정하기 위해 필수불가결하다는 공익이론과 규제는 수요와 공급의 논리에 따라 정책입안자와 특정이익집단 간의 이익 교환의 산물로 나타난다는 공공선택이론이 있다. 이 논문은 규제에 관한 두 가지 상반된 이론을 중심으로 규제가 창업과 혁신에 미치는 영향을 분석한 기존 연구를 소개하며, 이를 토대로 최근 한국 창업생태계를 중심으로 이른바 '파지티브 규제'방식과 '네거티브 규제'방식에 대한 논쟁이 시작된 배경을 심도있게 논하고자 한다. 비용효율성 중심의 경제 구조에서 혁신주도형 경제로의 전환을 모색 중인 한국 경제는, 창업생태계의 성장과 함께 나타난 혁신적인 스타트업이 정부 주도의 시장 규제방식을 맞닥뜨렸을 때 발생하는 문제와 그 영향을 연구하는데 유용한 사례를 제공한다. 한때 정부 계획 하에 수출과 산업화로 빠르게 성장한 제조업 중심의 한국 경제가 혁신 기반 경제로 전환되는 과도기적 시점이 글로벌 경영 환경에서의 제4차 산업 혁명의 시작점과 공교롭게 맞물리고 있는 지금, 혁신을 기반으로 하는 창업 생태계를 조성하는 것은 우리 경제가 향후 국제 시장에서 지속가능한 경쟁우위를 확보할 수 있도록 하는데 중요한 과제 중 하나다. 이는 비단 개별 기업의 노력뿐만 아니라 창업과 혁신에 대한 유인을 보호하고 투명하고 공정한 경영환경을 조성하기 위한 정부의 지원과 노력을 요하는 문제이다. 이러한 시점에서 정부의 규제방식이 창업기업의 진입과 혁신적인 제품 및 서비스에 미치는 영향을 한국의 사례에 비추어 살펴보는 것은 학문적·정책적으로 시의적절한 의의를 지닌다고 생각된다.

• Asian-Australasian Journal of Animal Sciences
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• 제16권11호
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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.