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Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices (의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발)

  • Kim, Yong-Woo;Shin, Chae-Min;Bang, Ji-Young;Yi, Jung-Yeon;Oh, Hyeon-Joo;Bae, Woo-Jin;Choi, Jin-Man;Lim, Kyung-Mi;Oh, Heon-Jin;Kim, Mi-Young;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kwak, Ji-Young;Kim, Su-Yeon;Hwang, Sang-Yeon;Youn, Hae-Suk;Hong, Hye-Kyeong;Ahn, So-Young;Lee, Chang-Hyung;Jeong, Jin-Baek;Koo, Ja-Jung;Kang, Se-Gu;Jung, Jae-Hoon;Lim, Kyoung-Taek;Lim, Chang-Keun;Kim, Min-Su;Lee, Seong-Hyi;Lee, Jae-Keun;Park, Ki-Jung
    • Journal of Biomedical Engineering Research
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    • v.31 no.4
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    • pp.280-284
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    • 2010
  • Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

Abstracting Services in Korea (한국의 초록서비스에 대하여)

  • Choi Sung-Jin
    • Journal of the Korean Society for Library and Information Science
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    • v.24
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    • pp.9-51
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    • 1993
  • The purpose of this study is twofold: to investigate into general characteristics of the abstracting services in Korea and to discuss general directions of development of the abstracting services in the country. This study is designed to achieve the purpose by gathering and analysing data related to the abstracting journals published in the past ten years and by comparing the results with similar data gathered by the investigator in 1984. The major conclusions made in this study is summarised as follows. (1) Researchers and professionals working in limited numbers of subject fields are benefited by abstracting services of recent achievements in research and development in Korea. Those in most of the fields have essentially no abstracting services of such achievements. Even many researchers and professionals in the limited numbers of the fields that have some elementary abstracting services are not informed of research results in their fields because the abstracting journals are scattered in many narrow subjects and in many cases, the abstracting journals only cover publications in some specific forms and kinds. (2) Abstracting journals of general subjects, which are supposed to be of more or less help to the researchers in the subject fields that have no abstracting journals of their own, have rapidly increased in number in the past ten years. Most of such abstracting journals carry thesis and dissertation abstracts, and the rest those of research papers published in specific places, in specific forms, by specific institutes, and of reports of research projects sponsored by specific foundations. These abstracting journals are not of the kind that comprehensively provide general readers with current awareness of publications of research results in Korea. (3) Most of the abstracting journals existing in Korea are published by institutions of higher education and research institutes, and the rest by commercial publishers, industrial firms, libraries, information centers, government agencies, research foundations, learned societies, etc. Those which publish many titles are small in number and those publish one or two titles are large in number. The former is largely made up of institutions of higher education and research institutes. (4) Ten years ago, there was not a single publishing house that produced abstracting journals. Three commercial publishing houses now produce abstracting journals. As this change occurs, centers of excellence are founded and competitive elements are introduced in abstracting services. This change, in turn, is expected to improve quality of the other abstracting journals in Korea. (5) The abstracting journals published in Korea are classified by type into those of dissertations, research papers, journal articles, patent specifications in that descending order. The fact that Master's and doctoral dissertation abstracts are dominating in Korea is due to the irrational practice of publishing those abstracts at many institutions. (6) Most of the abstracting journals existing in Korea are published by national or government-supported research institutes in order to publicise their own research outputs. Their coverage of literature is normally narrow, and naturally their value to users is limited. (7) The abstracting journals published in Korea increased in number at the rate of $77.8-100\%$ every five years in the past twenty-five years. Most of the abstracting journals that ceased to be published during the period survived for two years. (8) Korean is the desirable language for the abstracting journals designed to be distributed within Korea. About half of the abstracting journals published in Korea is printed in Korean and the other half in foreign languages, and in Korean with foreign languages. All the abstracting journals in foreign languages are printed in English xcept one, which is printed in Japanese. (9) Some twenty percent of the abstracting journals in Korea is published monthly, bimonthly, and quarterly. Others are published annually, biannually, and irregularly. The latter may not function properly as a current-awareness tool due to long intervals between their issues. It is particularly undesirable that about half of the abstracting journals in Korea is published irregularly. Most of the abstracting journals published in Korea are distributed freely to individuals and institutions selected by the publishers. (10) The abstracting journals published by the use of computers increased drastically in the past ten years. The abstracting journals produced by the conventional type-setting method will probably disappear In Korea in another ten years to come. Automation of the production of abstracting journals does not simply mean technical, economic improvement of publishing processes but availability of machine-readable databases that can be used for other purposes, including the generation of other publications and the provision of machine literature searching capabilities. Necessary steps should be taken for this important development that is occurring in the abstracting services in Korea.

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A study of SCM strategic plan: Focusing on the case of LG electronics (공급사슬 관리 구축전략에 관한 연구: LG전자 사례 중심으로)

  • Lee, Gi-Wan;Lee, Sang-Youn
    • Journal of Distribution Science
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    • v.9 no.3
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    • pp.83-94
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    • 2011
  • Most domestic companies, with the exclusion of major firms, are reluctant to implement a supply chain management (SCM) network into their operations. Most small- and medium-sized enterprises are not even aware of SCM. Due to the inherent total-systems efficiency of SCM, it coordinates domestic manufacturers, subcontractors, distributors, and physical distributors and cuts down on cost of inventory control, as well as demand management. Furthermore, a lack of SCM causes a decrease in competitiveness for domestic companies. The reason lies in the fundamentality of SCM, which is the characteristic of information sharing, process innovation throughout SCM, and the vast range of problems the SCM management tool is able to address. This study suggests the contemplation and reformation of the current SCM situation by analyzing the SCM strategic plan, discourses and logical discussions on the topic, and a successful case for adapting SCM; hence, the study plans to productively "process" SCM. First, it is necessary to contemplate the theoretical background of SCM before discussing how to successfully process SCM. I will describe the concept and background of SCM in Chapter 2, with a definition of SCM, types of SCM promotional activities, fields of SCM, necessity of applying SCM, and the effects of SCM. All of the defects in currently processing SCM will be introduced in Chapter 3. Discussion items include the following: the Bullwhip Effect; the breakdown in supply chain and sales networks due to e-business; the issue that even though the key to a successful SCM is cooperation between the production and distribution company, during the process of SCM, the companies, many times, put their profits first, resulting in a possible defect in demands estimation. Furthermore, the problems of processing SCM in a domestic distribution-production company concern Information Technology; for example, the new system introduced to the company is not compatible with the pre-existing document architecture. Second, for effective management, distribution and production companies should cooperate and enhance their partnership in the aspect of the corporation; however, in reality, this seldom occurs. Third, in the aspect of the work process, introducing SCM could provoke corporations during the integration of the distribution-production process. Fourth, to increase the achievement of the SCM strategy process, they need to set up a cross-functional team; however, many times, business partners lack the cooperation and business-information sharing tools necessary to effect the transition to SCM. Chapter 4 will address an SCM strategic plan and a case study of LG Electronics. The purpose of the strategic plan, strategic plans for types of business, adopting SCM in a distribution company, and the global supply chain process of LG Electronics will be introduced. The conclusion of the study is located in Chapter 5, which addresses the issue of the fierce competition that companies currently face in the global market environment and their increased investment in SCM, in order to better cope with short product life cycle and high customer expectations. The SCM management system has evolved through the adaptation of improved information, communication, and transportation technologies; now, it demands the utilization of various strategic resources. The introduction of SCM provides benefits to the management of a network of interconnected businesses by securing customer loyalty with cost and time savings, derived through the consolidation of many distribution systems; additionally, SCM helps enterprises form a wide range of marketing strategies. Thus, we could conclude that not only the distributors but all types of businesses should adopt the systems approach to supply chain strategies. SCM deals with the basic stream of distribution and increases the value of a company by replacing physical distribution with information. By the company obtaining and sharing ready information, it is able to create customer satisfaction at the end point of delivery to the consumer.

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Varieties of Community Unionism: A Comparison between the Youth Community Union and the Arbeit Workers' Union in South Korea (커뮤니티유니온의 다양성: 청년유니온과 아르바이트노동조합의 비교연구)

  • Yang, Kyunguk;Chae, Yeon Joo
    • Korean Journal of Labor Studies
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    • v.24 no.2
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    • pp.95-136
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    • 2018
  • As the number of precariats grows, their poor labor rights and working conditions are becoming issues of major concern all over the world but how to represent their interests is still controversial. Basically, the union is the institutional mechanism for representing the labor rights. However, it is difficult for workplaceand enterprise-based unions to fully represent the labor rights of precarious workers. Recently, so-called community unions have emerged in the United States, the United Kingdom, and Japan as independent organizations representing the rights of non-standard workers. Community unions refer to labor unions which organize precarious workers across firms at the regional level. They are known to be suitable for covering the unemployed, job seekers, indirect employment workers, short-term contract workers, and small-firm workers. In South Korea, since the financial crisis in 1997, a dramatic increase in the number of precariats leads to emergence of new types of trade unions such as the Youth Community Union, the Arbeit Workers' Union, the Artist Social Union and the Korea Musician's Union. They have engaged in various activities to guarantee the labor rights of precariats. Recently, researchers have also tried to identify defining characteristics of these new forms of unionism. To expand research on trade unionism in South Korea, this study compares two different types of community unions: the Youth Community Union and the Arbeit Workers' Union. We believe that this attempt can contribute to the research on the alternative labor movement. For this purpose, this study starts with theoretical discussions on community unions, and compares the Youth Community Union with the Arbeit Workers' Union based on the five characteristics of community unionism: membership and organization structure, the recognition struggle, the type or scope of interest, solidarity with other civic organizations, and the repertoire of resistance strategies. Based on this comparative analysis, this study seeks to foresee the possibility of how community unionism will develop in South Korean in the future.

A Study on the Key Factors Affecting Big Data Use Intention of Agriculture Ventures in Terms of Technology, Organization and Environment: Focusing on Moderating Effect of Technical Field (농업벤처기업의 빅데이터 활용의도에 영향을 미치는 기술·조직·환경 관점의 핵심요인 연구: 기술분야의 조절효과를 중심으로)

  • Ahn, Mun Hyoung
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.16 no.6
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    • pp.249-267
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    • 2021
  • The use of big data accumulated along with the progress of digitalization is bringing disruptive innovation to the global agricultural industry. Recently, the government is establishing an agricultural big data platform and a support organization. However, in the domestic agricultural industry, the use of big data is insufficient except for some companies in the field of cultivation and growth. In this context, this study identifies factors affecting the intention to use big data in terms of technology, organization and environment, and also confirm the moderating effect of technical field, focusing on agricultural ventures which should be the main entities in creating innovation by using big data. Research data was obtained from 309 agricultural ventures supported by the A+ Center of FACT(Foundation of AgTech Commercialization and Transfer), and was analyzed using IBM SPSS 22.0. As a result, Among technical factors, relative advantage and compatibility were found to have a significant positive (+) effect. Among organizational factors, it was found that management support had a positive (+) effect and cost had a negative (-) effect. Among environmental factors, policy support were found to have a positive (+) effect. As a result of the verification of the moderating effect of technology field, it was found that firms other than cultivation had a moderating effect that alleviated the relationship between all variables other than relative advantage, compatibility, and competitor pressure and the intention to use big data. These results suggest the following implications. First, it is necessary to select a core business that will provide opportunities to generate new profits and improve operational efficiency to agricultural ventures through the use of big data, and to increase collaboration opportunities through policy. Second, it is necessary to provide a big data analysis solution that can overcome the difficulties of analysis due to the characteristics of the agricultural industry. Third, in small organizations such as agricultural ventures, the will of the top management to reorganize the organizational culture should be preceded by a high level of understanding on the use of big data. Fourth, it is important to discover and promote successful cases that can be benchmarked at the level of SMEs and venture companies. Fifth, it will be more effective to divide the priorities of core business and support business by agricultural venture technology sector. Finally, the limitations of this study and follow-up research tasks are presented.

A Study on Intelligent Value Chain Network System based on Firms' Information (기업정보 기반 지능형 밸류체인 네트워크 시스템에 관한 연구)

  • Sung, Tae-Eung;Kim, Kang-Hoe;Moon, Young-Su;Lee, Ho-Shin
    • Journal of Intelligence and Information Systems
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    • v.24 no.3
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    • pp.67-88
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    • 2018
  • Until recently, as we recognize the significance of sustainable growth and competitiveness of small-and-medium sized enterprises (SMEs), governmental support for tangible resources such as R&D, manpower, funds, etc. has been mainly provided. However, it is also true that the inefficiency of support systems such as underestimated or redundant support has been raised because there exist conflicting policies in terms of appropriateness, effectiveness and efficiency of business support. From the perspective of the government or a company, we believe that due to limited resources of SMEs technology development and capacity enhancement through collaboration with external sources is the basis for creating competitive advantage for companies, and also emphasize value creation activities for it. This is why value chain network analysis is necessary in order to analyze inter-company deal relationships from a series of value chains and visualize results through establishing knowledge ecosystems at the corporate level. There exist Technology Opportunity Discovery (TOD) system that provides information on relevant products or technology status of companies with patents through retrievals over patent, product, or company name, CRETOP and KISLINE which both allow to view company (financial) information and credit information, but there exists no online system that provides a list of similar (competitive) companies based on the analysis of value chain network or information on potential clients or demanders that can have business deals in future. Therefore, we focus on the "Value Chain Network System (VCNS)", a support partner for planning the corporate business strategy developed and managed by KISTI, and investigate the types of embedded network-based analysis modules, databases (D/Bs) to support them, and how to utilize the system efficiently. Further we explore the function of network visualization in intelligent value chain analysis system which becomes the core information to understand industrial structure ystem and to develop a company's new product development. In order for a company to have the competitive superiority over other companies, it is necessary to identify who are the competitors with patents or products currently being produced, and searching for similar companies or competitors by each type of industry is the key to securing competitiveness in the commercialization of the target company. In addition, transaction information, which becomes business activity between companies, plays an important role in providing information regarding potential customers when both parties enter similar fields together. Identifying a competitor at the enterprise or industry level by using a network map based on such inter-company sales information can be implemented as a core module of value chain analysis. The Value Chain Network System (VCNS) combines the concepts of value chain and industrial structure analysis with corporate information simply collected to date, so that it can grasp not only the market competition situation of individual companies but also the value chain relationship of a specific industry. Especially, it can be useful as an information analysis tool at the corporate level such as identification of industry structure, identification of competitor trends, analysis of competitors, locating suppliers (sellers) and demanders (buyers), industry trends by item, finding promising items, finding new entrants, finding core companies and items by value chain, and recognizing the patents with corresponding companies, etc. In addition, based on the objectivity and reliability of the analysis results from transaction deals information and financial data, it is expected that value chain network system will be utilized for various purposes such as information support for business evaluation, R&D decision support and mid-term or short-term demand forecasting, in particular to more than 15,000 member companies in Korea, employees in R&D service sectors government-funded research institutes and public organizations. In order to strengthen business competitiveness of companies, technology, patent and market information have been provided so far mainly by government agencies and private research-and-development service companies. This service has been presented in frames of patent analysis (mainly for rating, quantitative analysis) or market analysis (for market prediction and demand forecasting based on market reports). However, there was a limitation to solving the lack of information, which is one of the difficulties that firms in Korea often face in the stage of commercialization. In particular, it is much more difficult to obtain information about competitors and potential candidates. In this study, the real-time value chain analysis and visualization service module based on the proposed network map and the data in hands is compared with the expected market share, estimated sales volume, contact information (which implies potential suppliers for raw material / parts, and potential demanders for complete products / modules). In future research, we intend to carry out the in-depth research for further investigating the indices of competitive factors through participation of research subjects and newly developing competitive indices for competitors or substitute items, and to additively promoting with data mining techniques and algorithms for improving the performance of VCNS.

Consumer's Negative Brand Rumor Acceptance and Rumor Diffusion (소비자의 부정적 브랜드 루머의 수용과 확산)

  • Lee, Won-jun;Lee, Han-Suk
    • Asia Marketing Journal
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    • v.14 no.2
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    • pp.65-96
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    • 2012
  • Brand has received much attention from considerable marketing research. When consumers consume product or services, they are exposed to a lot of brand related stimuli. These contain brand personality, brand experience, brand identity, brand communications and so on. A special kind of new crisis occasionally confronting companies' brand management today is the brand related rumor. An important influence on consumers' purchase decision making is the word-of-mouth spread by other consumers and most decisions are influenced by other's recommendations. In light of this influence, firms have reasonable reason to study and understand consumer-to-consumer communication such as brand rumor. The importance of brand rumor to marketers is increasing as the number of internet user and SNS(social network service) site grows. Due to the development of internet technology, people can spread rumors without the limitation of time, space and place. However relatively few studies have been published in marketing journals and little is known about brand rumors in the marketplace. The study of rumor has a long history in all major social science. But very few studies have dealt with the antecedents and consequences of any kind of brand rumor. Rumor has been generally described as a story or statement in general circulation without proper confirmation or certainty as to fact. And it also can be defined as an unconfirmed proposition, passed along from people to people. Rosnow(1991) claimed that rumors were transmitted because people needed to explain ambiguous and uncertain events and talking about them reduced associated anxiety. Especially negative rumors are believed to have the potential to devastate a company's reputation and relations with customers. From the perspective of marketer, negative rumors are considered harmful and extremely difficult to control in general. It is becoming a threat to a company's sustainability and sometimes leads to negative brand image and loss of customers. Thus there is a growing concern that these negative rumors can damage brands' reputations and lead them to financial disaster too. In this study we aimed to distinguish antecedents of brand rumor transmission and investigate the effects of brand rumor characteristics on rumor spread intention. We also found key components in personal acceptance of brand rumor. In contextualist perspective, we tried to unify the traditional psychological and sociological views. In this unified research approach we defined brand rumor's characteristics based on five major variables that had been found to influence the process of rumor spread intention. The five factors of usefulness, source credibility, message credibility, worry, and vividness, encompass multi level elements of brand rumor. We also selected product involvement as a control variable. To perform the empirical research, imaginary Korean 'Kimch' brand and related contamination rumor was created and proposed. Questionnaires were collected from 178 Korean samples. Data were collected from college students who have been experienced the focal product. College students were regarded as good subjects because they have a tendency to express their opinions in detail. PLS(partial least square) method was adopted to analyze the relations between variables in the equation model. The most widely adopted causal modeling method is LISREL. However it is poorly suited to deal with relatively small data samples and can yield not proper solutions in some cases. PLS has been developed to avoid some of these limitations and provide more reliable results. To test the reliability using SPSS 16 s/w, Cronbach alpha was examined and all the values were appropriate showing alpha values between .802 and .953. Subsequently, confirmatory factor analysis was conducted successfully. And structural equation modeling has been used to analyze the research model using smartPLS(ver. 2.0) s/w. Overall, R2 of adoption of rumor is .476 and R2 of intention of rumor transmission is .218. The overall model showed a satisfactory fit. The empirical results can be summarized as follows. According to the results, the variables of brand rumor characteristic such as source credibility, message credibility, worry, and vividness affect argument strength of rumor. And argument strength of rumor also affects rumor intention. On the other hand, the relationship between perceived usefulness and argument strength of rumor is not significant. The moderating effect of product involvement on the relations between argument strength of rumor and rumor W.O.M intention is not supported neither. Consequently this study suggests some managerial and academic implications. We consider some implications for corporate crisis management planning, PR and brand management. This results show marketers that rumor is a critical factor for managing strong brand assets. Also for researchers, brand rumor should become an important thesis of their interests to understand the relationship between consumer and brand. Recently many brand managers and marketers have focused on the short-term view. They just focused on strengthen the positive brand image. According to this study we suggested that effective brand management requires managing negative brand rumors with a long-term view of marketing decisions.

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