• 한국임상수의학회지
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• 제35권4호
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• 한국안전학회지
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• 제33권4호
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• pp.30-37
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• 2018

Although the safety management plan review system according to the Construction Technology Promotion Act for securing the safety of the construction work is a fundamental system essential for the prevention of the construction industry disaster, the necessity of its improvement has been raised because it often fails to meet the original purpose. In this study, through the analysis of the effect of the safety management plan and the problems of the operation, we suggest ways to improve it in view of the construction accident reduction and conducted surveys on the construction site through the questionnaires of the client, construction company, and construction business technology manager. In order to improve the effectiveness of this system as a result of the study, it is necessary to distribute the guidelines for the preparation of the safety management plan, manuals, etc., to simplify the contents of the safety management plan, also the step-by-step approval of the safety plan can be a solution. For this, it is necessary to revise the policy through consultation with the Ministry of Land, Transport and Maritime Affairs and related experts.

• 한국시스템다이내믹스연구
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• 제13권1호
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• pp.5-40
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• 2012

This study focus on oriental way for Win-win leadership of modern time using systems thinking approach. We constructed concept, 'Modesty Leadership' from oriental bible- Tao Te Ching, Change Ching, the Analects of Confucius. This work described in the paper based on case collected from 2011 Seoul city mayor election in the Korea. There are three initial aims : to confirm what feedback loop affected approval rating, to determine how these feedback interacted and to establish the significance of cognitive mapping. The use of system thinking to model cognitive mapping of political election untraditional approach in study of oriental bible. This approach is valuable in that it can be to understand management strategies and their effect on decision making.

• 보건행정학회지
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• 제28권3호
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• pp.272-279
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• 2018

Since the introduction of new health technology assessment in 2007, benefit coverage process of health insurance related to new health technology has become an upgraded system through the evidence-based decisions. As a result of enforcing this system for 10 years, however, there have been several rising concerns. It needs to support the insufficient evidence of medical technologies, introduce reassessment system for post management of market entry technologies, and improve evaluation methods and process. In addition, there is the possibility of emerging an unheard-of medical technology, fused various categories like artificial intelligence, robot, information technology, physics and life science in the fourth industrial revolution. Now, new updated system introduced to improve new technology assessment, such as 'limited health technology assessment system,' 'system for postponement of new health technology assessment,' 'one-stop service system,' and 'integrated operation of approval for medical devices and new health technology assessment.' Therefore it needs to prepare the improvement plan for new health technology assessment to be established more advanced system, and we have to resolve concerns by communication with various healthcare experts and patients now and for ever.

• 한국기록관리학회지
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• 제16권2호
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• pp.81-112
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• 2016

본 연구의 목적은 정부3.0에 추진에 따라 기록관리와 정보공개 체계를 수립해야 하는 상황에 놓인 정부산하공공기관들이 설명책임 강화 요구에 신속히 대응하면서 동시에 업무효율성을 높이기 위해 '업무관리시스템'을 도입할 것을 제안하고 기능과 개발방향성을 제시하는데 있다. 최근 기록관리와 정보공개 체계를 도입하는 정부산하공공기관들 중에 전자결재 기능 위주의 전자문서시스템을 도입하고 이에 맞춰 기록물분류기준표를 개발하는 경우가 발생하고 있다. 다종다양한 업무시스템을 운영하고 있는 정부산하공공기관들이 기록관리와 정보공개에 잘 대응하기 위해서는 문서 결재 외에도 과제관리 및 통제, 의사결정 과정을 지원하는 '업무관리시스템'이 필요하다고 본다. 본 연구에서는 최근 자체 기록관리시스템을 개발하고 전사적 기능분류체계를 구축한 후 기관 맞춤형 '업무관리시스템'을 도입하고자 정보화전략계획을 수립한 A기관의 사례를 살펴보면서 정부산하공공기관의 전자기록생산시스템의 도입 방향성을 제시하고자 하였다.

• 환경영향평가
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• 제22권2호
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• pp.183-194
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• 2013

The Ministry of Environment, Ministry of Agriculture, Fishery and Forestry, and Ministry of Construction, Transportation and Maritime Affairs are in charge of livestock manure management. There are national statistics regarding the livestock industry such as the National Pollution Source Survey, Livestock Statistic Survey, and Livestock-breeding Trend Survey. The current statistical data are focused on the scale of livestock breeding and the production of livestock manure using these data, but it is difficult to establish database due to lack of information. In order to plan relevant policies including management of livestock manure, the government established database systems such as the integrated information system of livestock manure, the integrated system of national infectious animal-disease prevention, and the Sae-ol public administrative system. We have tried to suggest improvements for the comprehensive environmental information system of livestock manure management by detecting problems in each level of the livestock manure life-cycle, making use of the existing systems, and considering the electronic transfer system of livestock manure. The services and functions of this comprehensive system include information of livestock farmers, the production, collection, transportation, and treatment of livestock manure, the area of agricultural land used for livestock manure, the report of approval and results on livestock manure products, management of statistical information, management of civil affairs, and relevant mobile application services. The system is made up of three processes: first, establishment of GIS-based management database of livestock manure; second, establishment of a history management system for livestock manure transactions; and third, development of a water quality assessment system.

• 한국가스학회지
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• 제22권3호
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• pp.74-83
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• 2018

국소배기장치를 설치하려는 경우 환경부 허가를 받더라도 고용노동부 허가를 새로 받아야 한다. 이는 대기환경보전법 뿐만 아니라 산업안전보건법 제48조2에 따른 제조업 유해위험방지계획서를 착공 15일 전까지 제출하도록 되어 있기 때문이다. 현행 환경부 대기환경보전법에서는 국소배기장치의 오염원을 대기 중으로 배출되는 부분만 규제하고 산업현장 내에서의 근로자 안전보건에 관한 내용은 산업안전보건법 등 고용노동부 소관 법률로 관리된다. 환경부의 승인을 받은 것임에도 고용노동부의 불승인 사례가 증가하여 생산지연 및 추가 개선비용에 따른 사업장의 불만이 커지고 있다. 또한, 화재 폭발의 위험성이 큰 국소배기장치의 경우 화재 폭발에 의한 중대산업사고 위험성이 증가하고 있다. 원인은 배풍량, 제어속도, 반송속도, 덕트구경, 화재폭발 위험성 등의 설계가 미흡했기 때문이다. 이는 국소배기장치 승인기준 및 절차는 대동소이 하나 산업안전보건법에서 근로자의 안전보건 및 화재 폭발에 대한 심사항목이 추가되어 있기 때문이다. 본 연구에서는 환경부와 고용노동부에서 이원화 되어 있는 국소배기장치 설치 승인기준을 비교 분석하여 합리적인 제도운영 방안을 모색하고자 한다.

• 수산해양교육연구
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• 제27권4호
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• pp.912-923
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• 2015

In the results of analyzing Korean corrective action for what are required to be improved according to EU listing Korea as yellow-card non-cooperating third countries against IUU fishing, in order to establish advanced fishery order, it is thought that the following additional improvements are required. (1) The introduction of integrated management system of fishing vessel sailing route, fishing activity, fish catch, and inshore fishing vessel must be considered. (2) It is necessary to establish a system to cross check catch transaction, catch landing, and fish catch report submitted by fishing vessel. (3) Catch transshipment approval system shall be introduced. And a system of reporting and checking catch transshipment at sea shall be reinforced. (4) Punishment shall be strengthened to the extent of making people to perceive that loss due to punishment is larger than profit made from illegal fishing. (5) It shall be so improved that more than a certain percentage of all vessels with fish and fish products caught in waters outside Korea's judicial waters shall be arbitrarily chosen and searched besides a case of being suspected to be IUU fishing. In conclusion, on being listed by EU as yellow-card non-cooperating third countries against IUU fishing, Korean fishery management system shall be generally reexamined, and it shall serve as an occasion to exterminate IUU fishing and to advance fishery management system.

• 의료법학
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• 제22권4호
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• pp.59-88
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• 2021

최근 제약기업이 조작한 자료를 제출하여 심사를 받아 의약품 품목허가를 받은 사례들이 적발되었다. 국회는 제약기업의 자료조작에 대한 제재를 강화하는 입법을 하였다. 현재와 같은 의약품 품목허가 제도는 Elixir Sulfanilamide 사고나 탈리도마이드 사고와 같이 의약품으로 인하여 환자들의 생명과 건강에 중대한 피해를 초래한 사건들을 경험하면서 그것을 방지하기 위하여 만들어졌다. 의약품 품목허가에는 위험이 내재되어 있다. 의약품 품목허가는 제약기업이 제출한 자료에 조작이 없다는 신뢰를 토대로 한 심사를 통해 우리 사회에 진입 가능한 위험에 대한 잠정적 허용 결정이다. 제약기업의 자료조작은 국민의 생명, 건강에 위해를 가하고 우리나라 제약산업의 경쟁력에 위해를 초래한다. 제약기업의 경제적 이윤 동기를 고려하면 우리나라 제약산업에서 자료조작이 '합리적인' 선택으로 자리잡을 우려가 있고 그럴 경우 그로 인한 피해가 일상화된다. 대법원 2008. 11. 13. 선고 2008두8628 판결은 제약기업이 아닌 제3자가 자료조작을 하였고 자료조작을 하지 않았어도 품목허가 요건이 충족되는 사례에서 의약품 안전성 확보를 위해 엄격하고 엄정한 기준이 요구된다고 밝히며 의약품 품목허가 취소 처분이 위법하지 않다고 판단하였다. 대법원의 입장이 타당하다. 제약기업이 자료조작으로 얻을 수 있는 기대이익을 최소화함으로써 제약기업이 자료조작을 선택할 경제적 유인을 약화시켜야 한다. 그러므로 해당 의약품의 품목허가를 취소할 뿐만 아니라 제약기업이 그로 인하여 얻은 '부당한' 이익을 환수해야 한다. 그리고 자료조작 적발 가능성을 높이기 위하여 내부자 고발을 활성화하고 품목허가 심사료 현실화 등을 통하여 품목허가 심사 인력 등 심사역량을 강화해야 한다.

• 한국CDE학회지
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• 제4권2호
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• pp.30-35
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• 1998

Recently, many enterprises wish to preoccupy competitive positions in the market by motivating themselves towards CALS(Commerce At Light Speed) and try hard to achieve system implementation with the use of new concept-based backbone systems such as ERP(Enterprise Resource Planning) or PDM(Product Data Management). However, unfortunately there is an inevitable discrepancy during implementation period between package vendors and customers due to lack of clear methodology and misunderstanding about system. In some cases, consensus on partially verified system design invokes customers'continuous change demands and often it tends to result in unnecessary project delays. PDM application system implementation project of the company L has been studied here to solve these sorts of problems. The major yields of this work are achievement of a willing approval from customers and rapid system design under a time-limited and conceptually defined project scope and finally, through fully verified system design, we were able to reach successful system implementation.