• 제목/요약/키워드: regulatory guidelines

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Searching for Best Practices in Developing Ports as Logistics Centers

  • Jun, Il-Soo;Yi, Sang-Won
    • 한국항만경제학회지
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    • 제21권4호
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    • pp.183-207
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    • 2005
  • Global firms are seeking to implement their global logistics strategies in two ways: the use of centralized inventories and/or postponement of final assembly. These strategies stress the importance of regional logistics centers. In most cases, regional logistics centers are located in or near ports so that changing demands can be met with economy, reliability and flexibility, The port can profit not only from the activities of logistics center itself, but also the increasing flow of cargo through the logistics center. A number of ports respond to this trend by shifting their emphasis from traditional cargo-handling services to value-added services. This paper presents guidelines drawn from the best practices of ports to be successful logistics centers to provide many aspects of value-added logistics services. These include: Effective Planning and Development of Logistics Centers; Institutional Incentive Scheme; Development of Free Trade Zones; Financing Infrastructure related to Logistics Centers; Developing Logistics Service Providers and Logistics Professionals; Development of Information Technology; and Regulatory and Administrative Issues. These guidelines will help managers of ports and policy makers of governments in the East Asian region learn to recognize, analyze and adopt the best practices for use.

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야영장 화재 안전대책에 관한 연구 (A Study on the Safety Measures of Camping Ground Fire)

  • 최지훈;최돈묵
    • 대한안전경영과학회지
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    • 제18권1호
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    • pp.57-64
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    • 2016
  • The leisure life pattern of people is changing to a familial and enthusiastic way that eventually develops the camping culture. Thus, the number of campers and the size of camping market have been dramatically increased due to significant expansion of camping people. However, many camp grounds and facilities are operating without a proper registration by government rules and regulations. In addition, many of electronic and gas equipment and tools are not used in a safe way and in a safety regulatory boundary. Therefore, campers at the camping ground is situated in a fire and safety hazard. In addition, there is limitation in rules and regulations associated with camping ground safety and fire. This study analyzed the fire and hazard guidelines and rules regulations of developed countries of campground and compared them to the current situation in South Korea. Therefore, this study is to develop a safety and fire hazard guidelines and rules and regulations related to camp ground operation, gas and electronic equipment operation and management. The study will eventually reduce the future fire and safety incidents in a campground in South Korea.

Rejection of DNA, Protein-DNA Complexes and Chromatin by Hollow Fiber Membranes

  • Higuchi, Akon;Hara, Mariko;Sato, Tetsuo;Ishikawa, Gen;Nakano, Hiroo;Satoh, Sakae
    • 한국막학회:학술대회논문집
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    • 한국막학회 1996년도 추계 총회 및 학술발표회
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    • pp.18-21
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    • 1996
  • Virus and DNA removal in bio-drug manufacturing processes has received a great deal of attention in recent years. Removing of a virus using a membrane process is a promising method, because inactivated virus can be removed from the bio-drug and the process can be used as an additional and security inactivation after the method of general heat-inactivation of the virus in the bio-drug. The FDA and the biopharmaceutical industry have recently announced strict guidelines for impurities of virus and DNA contamination. The regulatory guidelines on residual amounts of DNA in mammalian cell culture products require DNA contamination of less than 100 pg/dose. Therefore, permeation and rejection of DNA through the porous membranes have become important in the application of DNA removal in bio-drug manufacturing using membrane technology. In this study, the permeation of DNA and chromatin through regenerated cellulose hollow fibers that have a mean pore diameter of 15 nm was investigated.

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국내 및 해외의 임상시험 데이터모니터링위원회 지침의 현황 (Independent Data Monitoring Committees: Review of Current Guidelines)

  • 이보람;이경은
    • 한국임상약학회지
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    • 제26권2호
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    • pp.181-186
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    • 2016
  • Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

대학보건실의 운영체계 및 건강증진 서비스 제공 실태 (Health Promotion Services and Administrative System of the University Health Clinic)

  • 박천만;김영복
    • 보건교육건강증진학회지
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    • 제27권2호
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    • pp.151-163
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    • 2010
  • Objectives: This study was conducted to analyze problems and priority of university health services through analysis of health promotion programs and administrative system of university health clinics. Methods: In first telephone survey, 349 colleges and universities nationwide were surveyed to find out whether they operate health clinic or not. The administrative system and health promotion services of university health clinics were analyzed in 198 schools which had health clinic in it. Results: 160 schools were included in the final analysis. The most common name of university health clinic was 'health clinic' (35.2%), and heads of 52 university health clinics were non-medical school professors. 20.9% of the school provided details of the rules and implement guidelines of health care service. Health promotion services of university health clinic were set the non-smoking area (90.6%), health counseling (81.8%), providing health information (74.8%), health check-up (65.4%), health education (61.4%), partnership with health institutions in a community (61.4%), and immunization (48.1%) in order of that. Conclusion: It is urgent to establish the regulatory and guidelines for university health clinic. Each member of school should have interests in their health clinic and acknowledge health promotion services which they can get at the university health clinic.

나노 물질 및 제품의 안전 관리: 윤리적 원리 및 행위지침 고찰 (Safety Management of Nanomaterials and Nanoproducts: Thinking of Ethical Principles and Guidelines for It)

  • 이중원
    • 한국진공학회지
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    • 제19권6호
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    • pp.415-422
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    • 2010
  • 최근 나노 물질의 독성에 대한 보고와 나노 물질을 함유한 제품들의 급속한 증가 그리고 제조 과정에서의 나노 물질의 폭 넓은 응용으로 인해, 나노 물질 및 제품의 안전 관리 문제가 중요한 쟁점으로 부상하고 있다. 특히 작업장에서의 안전, 제품을 사용하는 소비자의 안전 그리고 환경 보호 등 나노 물질 및 제품의 전주기 과정에 걸친 안전 확보가 문제다. 하지만 나노 물질 및 제품의 위험이 잠재적이고 불확정적이기에, 이것들을 대상으로 하는 엄격한 안전 관련 규제체계를 구축하는 것은 어렵다. 본 논문에서는 이러한 쟁점들과 관련하여 나노 물질을 연구 개발하고 나노 제품을 생산하는 각 기관들이 안전에 관한 책임 있는 거버넌스(governance)를 구현하기 위해 현재 최선의 것으로 취할 수 있는(엄밀히 말해 취해야 하는) 윤리적인 행위 조치들과 이에 바탕이 되는 윤리적인 원리들을 살펴보고자 한다. 그리고 이것이 법적.제도적인 차원의 견고한 안전관리 체계를 구축하는데 중요한 한 축을 형성함을 강조하고자 한다.

복지 사육환경에서 산란계 및 육계의 사양지침 변화 (Changes in the Feeding Regimen for Chicken Under Welfare-bestowed Environment)

  • 이준엽;이용준;채병조;이정헌;윤석민;이명호;오상집
    • 한국축산시설환경학회지
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    • 제16권1호
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    • pp.61-80
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    • 2010
  • Poultry welfare has recently appeared as worldwide concern as well as Korea. The recent action plan for farm animal welfare introduced by the European Commission intends to expand the body of regulatory standards. In this context, many countries and/or organization are on the verge of establishing the most optimum poultry welfare standards. To establish the most optimum standards, comparative analysis of feeding regimen before and after welfare-bestowed environment need to be preceded. Most guidelines or standards for poultry welfare do not suggest the nutritional requirements and feeding system in detail, although it is deterimental especially for the farmer. This review intends to find scientific base to establish detailed welfare feeding guidelines. However, only limited research has been conducted in the view of actual poultry welfare. The results indicated the incidence of SDS, ascites, skeletal dysfunctions caused by fast growth rate in broiler, feather pecking and cannibalism in laying hen, and feed restriction in broiler breeder could be reduced by changing nutritional regimen and feeding strategies or both. The regimen and feeding strategies are certainly near to the direction that the poultry welfare ought to be in the right track. In this article, feeding and drinking guidelines in many standards as well as welfare feeding experiments have been reviewed and compared In the view of chicken productivity, welfare physiology and poultry health.

Licensing Approach for New Fuel Design

  • Ahn, Seung-Hoon;Park, Jun-Sang;Auh, Geun-Sun;Koo, Bon-Hyun;Lee, Seung-Hyuk
    • 한국원자력학회:학술대회논문집
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    • 한국원자력학회 1998년도 춘계학술발표회논문집(2)
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    • pp.1026-1031
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    • 1998
  • A licensing approach for new fuel design is propose. It includes the possible licensing options to be taken according to the level of significance of design changes. This approach can be applied on legal grounds of the AEA, Article 44.3 and Article 21, but implies that the related ERAEAs should be revised or other alternative regulatory guidelines should be prepared. However, it is not intended to invoke additional requirements but rather to streamline and formulate the current practice by using one of supplementary provisions of the AEA, Article 104.2 which is recently enacted for approval of the technical report on a special topic.

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광양제철소 산소공장 위험특성 도출 및 중요도에 근거한 향상 안 제시

  • 최종승;김영수;김연종;박진섭
    • 시스템엔지니어링워크숍
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    • 통권1호
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    • pp.65-68
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    • 2003
  • The air separation plants in the POSCO's Gwangyang Steel Works require high standard on quality as well as reliability as they have to continuously supply essential utility gases as oxygen, nitrogen and argon. And the plants are in the category of high pressure gas systems by the regulatory guidelines, which signifies that they have to maintain utmost level of safety. As an effort to systematically understand and calculate the risk potentials in the air separation plants, risk assessments have been performed on a phased approach: qualitative and followed by quantitative POSCO has chosen to use hazard and operability study and fault tree analysis to satisfy the requirement. As a result, the risk assessment team has identified number of safety and operability related findings. With importance of each and ever findings calculated, a priority list for what/when to do for them could have been presented on a balance fashion.

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독성병리 Peer Review의 중요성과 실제적 접근방법 (Importance of Peer Review in Toxicological Pathology and Its Practical Approach)

  • 손우찬;김배환;장동덕;한범석;양기화;이영순
    • Toxicological Research
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    • 제20권1호
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    • pp.1-11
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    • 2004
  • Evaluation of toxicological pathology is to some extend subjective judgments by pathologist and the accuracy of pathologist's works is based on the individual training and experiences. It has been required to establish a peer review system for toxicologic pathology and these review system has been employed by various practice of toxicological pathology. It would be pointed out that the possible causes of drifts in pathology are due to 1) lack of knowledge or experience of individual pathologists, 2) poorly maintained consistence of grading among animals in study, 3) different interpretation of findings between pathologists, or 4) pathology data processing. Example cases of diagnostic errors and current practice of peer review including tissue selection criteria, documentation and problem resolution for short-term and carcinogenicity studies were introduced. For sound regulatory system and high integrity of practice in toxicological pathology, current approaches of peer review system were reviewed.