• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Journal of Venture Innovation
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• v.5 no.3
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• pp.19-40
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• 2022

The purpose of this study is to analyze and evaluate the role and merits and demerits of insurance agencies, which are the main sales channels of the domestic insurance market, from a neutral standpoint, and to present a roadmap by finding ways and tasks for the sustainable development of the insurance agency industry. Recently, criticisms and regulations on independent distribution channels have been strengthened due to deterioration in growth potential and profitability, and increase in civil complaints of insurance companies. In the 2000s, as the center of insurance sales channels shifted to GA and bancassurance, the supervisory authorities regarded the irrationality of project costs and recruitment fees as the root causes and announced a regulatory improvement plan. In view of these circumstance, the operating status, problems of domestic insurance agencies and their contribution to the insurance industry were reviewed. In addition, we tried to find a mid-to-long term development plan by analyzing the case of insurance agency operation in Japan. This study identified the operating status and contribution of insurance agencies in South Korea, and focused on the major status of the Japanese insurance agency industry, ways to improve management efficiency, and the status and role of self-regulatory organizations for insurance agencies. Based on this, it was proposed to improve the professionalism of the sales organization, introduce a company specializing in insurance sales, and to strengthen the status of the association of the insurance agency as for the development plan of the insurance agency industry in South Korea.

• Journal of Korean Society for Atmospheric Environment
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• v.34 no.2
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• pp.342-355
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• 2018

Emission inventory (EI) is often recognized as a foundational pillar for air quality planning. In this manuscript, we reviewed national emission inventory (NEI) development processes in United States(US) and made recommendations for South Korean emission inventory development for the future. First, we examined history of emission inventory development in US while focusing on what has been success and failure. We noticed that, in general, emission reductions led to air pollution abatement although efficacy of same degree of reduction may not result in similar air quality improvement. Second, we described conventional approaches of developing NEI and differences between NEI and EI for State Implementation Plan which is required for air quality management in US. Last, we analyzed how US Environmental Protection Agency and counterpart agencies in states came up with a new plan for the next major regulatory modeling project. Based on our analysis, we conclude that early and steady participation of local governments will lead to effective and efficient emission inventory development and, in turn, will result in successful air quality planning that is necessary for actual air quality improvement.

• Journal of Environmental Science International
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• v.23 no.6
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• pp.1111-1120
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• 2014

Ulsan made its contributions to modern Korea as an industrial city. In the 1960s, Ulsan was appointed as a special industrial zone. After that, industrial complexes were built without environmental considerations so Ulsan was once called "the polluted city". However, in the early 2000s, the main concern of Ulsan's policies was gradually shifted from the economic growth to the environmental issues. In order to enhance the environmental quality and to make the Ulsan more environmentally friendly eco-city where human and nature coexist, Ulsan city declared "The Eco-polis Ulsan" in 2004 based on "The Master Plan for Eco-polis Ulsan" which included the eco-industrial park as an action plan. This study aims at defining the concepts of eco-city and policies to build Ulsan-style eco-city as environmentally friendly city and proposing Ulsan as a role model to cities and towns of developing countries. In addition, Ulsan's EIP project which will be implemented for 15 years from 2005, is elaborated including regulatory issues and technologies to be applied.

• Asia Marketing Journal
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• v.10 no.2
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• pp.71-98
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• 2008

Considerably many numbers of studies on country-of-origin(hereafter COO) effects have been presented in international business and marketing areas. Recent studies have been included the effects of COO of manufacture, parts, and design, as well as the effects of brand origin, reflected by the accelerating convergent manufacture circumstances and increasingly competitive environments. Moderating constructs such as knowledge of product category and involvement as individual variables, have been also introduced and researched in various angles. In addition, how the effects of COO occur as processes is also argued in previous studies. This research has attempted to explain business corporation's strategic decisions on choosing a domain of its product manufacturing for several critical reasons, for cost reduction or better image. We displayed two constructs of brand and manufacture in a positive and negative country image group to reconfirm the existence of the effects of COO. Additionally, the effects of respondents' regulatory fit between their motivational focus and the contents of product messages, have been declared. Furthermore the respondents' motivational focus moderates the main effect of COO on product evaluations in a positive 'made-in' combination, while, surprisingly, it does not statistically moderate in a negative, except attitude. Based on the results, implications and suggestions on how to plan and execute more effective marketing strategies regarding COO dimensions, especially COO of manufacture, are separately presented for each situations when it has already been determined and when it is to be.

• Journal of Venture Innovation
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• v.6 no.4
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• pp.83-97
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• 2023

The growth of the live commerce market allows you to conveniently and simply start live commerce anytime, anywhere with a smartphone. The use of smartphone services provides continuous communication and is used while feeling psychological attachment, and it leads to psychological attachment, self-consistency with consumers themselves, and self-identity. This study focuses on the motives and perceptions of consumers using live commerce. In other words, we will examine the relationship with service attachment through the moderating effect of self-efficacy and control focus tendency as consumers' personal and psychological characteristics. In other words, the tendency of regulatory focus, which determines the direction of behavior of consumers according to their motives and goals, affects the service attachment of live commerce. We believe that self-efficacy, which is personal confidence and belief that you can plan and execute on your own for the desired outcome in a given situation or task, will control this relationship. As a result of this research, consumers who highly perceive prevention focus were more likely to avoid negative consequences and pursue safety and obligations. Their attachment to live commerce services was stronger, offsetting their confidence and self-efficacy. When using live commerce services, the more they perceive that information acquisition is beneficial, the higher their belief, and self-efficacy, so service attachment, which is an emotional experience as well as a cognitive experience, is strongly formed for consumers with a preventive focus to avoid safety-seeking and negative consequences. Through the present research results, we believe that it will be helpful in operating strategies and management for companies and small business owners who want to understand the psychological behavior of consumers in using live commerce services.

• Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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• 2013.04a
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• pp.589-595
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• 2013

A reactor vessel internals comprehensive vibration assessment program(RVI CVAP) of an advanced power reactor 1400(APR1400) is being verified on the integrity of RVI for the design life of the plant by performing the non-prototype category-2 type on the US Nuclear Regulatory Commission Guide(NRC RG) 1.20, for which consists of a vibration and stress analysis program, a limited vibration measurement program, an inspection program, and the correlation of these programs. The aim of this paper is to describe the plan for the vibration measurement, test and acceptance criteria portion, and documentation and results of the APR1400 RVI CVAP. We will conduct the limited vibration measurement program of the APR1400 RVI CVAP according to the measurement plan and the vibration measurement testing in this paper.

• Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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• v.25 no.2
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• pp.87-95
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• 2011

A Renewable Portfolio Standard(RPS) is a regulation that requires the increased generation of energy from renewable energy sources such as solar, wind, fuel cell, small hydro, biomass and geothermal. By environmental, technical and these regulatory reasons, the amount of renewable energy sources will be increased in a network. However, it is hard to assess risk of a transmission network with large scale renewable energy sources because the output characteristics of renewable energies are intermittent. This paper evaluates effects of a transmission system with supplemental large scale renewable energies into the existing system. To evaluate these effects, a methodology for risk level of components in a network is proposed considering steady state and contingency N-1 in this paper. We consider line current and bus voltage in each state of a network.

• The Korean Journal of Air & Space Law and Policy
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• v.8
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• pp.297-332
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• 1996

It is well observed in the satellite telecommunication policy of several States that legal constraints imposed upon the service coverage of satellite telecommunication as well as broadcasting are to be relaxed in a progressive way. Major aspects of such policy change lie in the adoption of policy refusing traditional concept of national frontier. In the case of direct broadcasting satellite service, while a debate upon the legal issues regarding the spill-over effect of that service is no more major concern of the States, many multinational enterprises are looking for strategic alliance for regional or global DBS project. On the other hand, an implementation plan for connecting the world through global mobile personal communication satellite system is being pursued by several joint effort of multinational firms. Legal issues arise regarding the regulatory competence of each State, Especially, a controversial issue is concerning the sovereign right well recognized upon the regulation of telecommunication. This study is focusing upon the evolution of such policy change for the purpose of allowing us to expect future develpment of worldwide satellite telecommunication policy environment.

• Journal of the Korean Home Economics Association
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• v.43 no.1 s.203
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• pp.203-223
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• 2005

TV advertising(TV ad.) to children consumers is a useful method for both business and consumer socialization of children. The object of this study was to see if children could put TV ad. to practical use as a tool for purchasing information and as a learning method. For these purposes, the contents of TV ad. to children consumers were analyzed and their influence on children researched. Based on the findings of this study, it is suggested that TV ad. toward children consumers should be regulated and regulatory guidelines for children's ad. developed to create a better environment for children consumers.