• 제목/요약/키워드: Approval of use

검색결과 242건 처리시간 0.028초

활성물질을 사용하는 선박평형수 처리장치의 IMO 승인 절차 고찰 (Consideration of the Procedure for IMO Approval of Ballast Water Treatment System that Make Use of Active Substances)

  • 김은찬
    • 한국해양환경ㆍ에너지학회지
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    • 제11권4호
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    • pp.214-220
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    • 2008
  • 선박평형수 관리 협약에서 활성물질을 사용하는 선박평형수 처리장치는 IMO가 제정한 절차에 따라 IMO로부터 승인을 받아야하는 것으로 되어 있다. 협약에서 활성물질이란 유해 수중 생물과 병원균에 대하여 바이러스나 균류를 포함한 일반적인 또는 특정한 작용을 하는 물질 또는 생물을 말한다고 되어 있다. IMO 해양환경 보호위원회에서는 2008년 10월까지 13개의 선박평형수 처리장치에 기본승인을 부여하였고 4개의 처리장치에 최종승인을 부여하였다. 본 논문에서는 "활성물질을 사용하는 선박평형수 관리시스템의 승인을 위한 절차서(G9)"와 "GESAMP-BWWG의 정보 수집과 업무 수행을 위한 방법"에 근거하여 기본승인과 최종승인의 절차와 문서의 요소를 고찰하였고, IMO로부터 기본승인 또는 최종승인을 받은 처리장치의 승인 내용을 요약하였으며, 이로부터 몇 가지 문제점을 제기하였다.

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소방공무원의 효율적인 전자결재시스템 활용방안에 관한 연구 (A Study on the Application of the Electronic Approval System for the Fire Officer)

  • 우성천;채진
    • 한국화재소방학회논문지
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    • 제20권3호
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    • pp.54-64
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    • 2006
  • 정보통신기술(IT)의 급속한 발전은 공직사회 전반에 새로운 변화를 요구하고 있으며, 정부도 정보기술을 토대로 공공부문의 생산성과 효율성을 진작시키기 위해 부단히 노력하고 있다. 본 연구의 목적은 전자결재시스템의 운영에 관한 사항을 평가하고, 운영상 나타난 문제점을 바탕으로 효과적인 활용 방안을 제시하는 데 있다. 연구의 결과를 통해 효율적인 전자결재시스템의 활용을 위해 체계적인 교육, 결재업무절차의 개선, 시스템 안정, 시스템 처리속도 개선, 기관별 시스템 연계 등을 제시하였다.

철도안전법의 제작자 승인 기술기준에 대한 연구 (Technical Specifications for Manufacturer Approval in Railway Safety Law)

  • 이환덕;정원
    • 한국신뢰성학회지:신뢰성응용연구
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    • 제15권1호
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    • pp.19-26
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    • 2015
  • The amended law of railway safety in Korea has recently come into effect in order to strengthen the railway safety management system. The new law, which took effect March 1, 2014, will implement stricter oversight of railway companies. As a result, a company that manufactures railroad system or components for domestic use must obtain an approval in accordance with the technical specifications of manufacturer approval. Although Korea had established the legal system in enforcing railway safety, the government wants the companies continue to develop the more improved safety systems until they gain competitive edge on the world class railway manufacturers. This paper presents an in-depth analysis of the technical specifications for manufacturer approval in International Railway Industry Standard (IRIS), which is the global standard. This paper also proposes measures and guidelines that would help Korean manufacturers those who want further develop their safety management systems, as a prerequisite for them to obtain the manufacturer approval.

암호 알고리즘을 이용한 XML 기반 비즈니스문서의 전자 결재 시스템 (Electronic Approval System of XML-based Business Document using Crypto Algorithm)

  • 김창수;정회경
    • 한국정보통신학회논문지
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    • 제10권11호
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    • pp.1983-1988
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    • 2006
  • 산업의 주축이 정보 중심적으로 변화되고 있는 시점에서, 정보 공유에 대한 처리 역시 전자화, 자동화되고, 인터넷을 효율적으로 사용하기 위한 전자상거래 시스템과 비즈니스 정보시스템이 구축되고 있다. 전자상거래 및 비즈니스 정보시스템에서의 비즈니스 문서의 활용은 비약적으로 증가된 상태이며, 기업 내 정보공유에 이르기까지 그 영역이 확대되고 있어 비 즈니스 문서의 전자결재 시스템 개발은 필수적이다. 현재 그룹웨어 기반으로 개발된 전자결재 시스템들은 결재처리에서 서명 이미지를 삽입하는 방식을 사용하고 있다. 이것은 서명 도용, 전자문서의 가로채기 공격 등 많은 보안 취약성을 지닌다. 본 논문에서는 비즈니스 문서 구조를 가지는 DTD를 기반으로 유효한 비즈니스 XML문서 작성을 위한 XML폼 생성 기를 구현하였다. 작성된 XML 비즈니스 문서의 기밀성을 보장하고 신속한 전송처리를 행하기 위하여 서버와 클라이언트의 키 교환에 공개키 교환 방식의 암호 알고리즘의 비밀키를 사용하여 문서를 암호화한 후 전송 가능한 안전한 XML 기반 비즈니스 문서의 전자결재 시스템을 설계하였다.

소아환자의 Vancomycin에 대한 약물사용 평가 (II) -제한항균제로 사용규제 강화 후의 효과 (Drug Use Evaluation of Vancomycin in Pediatric Patients (II) -The effect of Approval for Vancomycin Use)

  • 이정민;이순실;김영주;신완균;이병구;이환종
    • 한국의료질향상학회지
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    • 제1권1호
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    • pp.32-43
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    • 1994
  • The 'Pharmacy and Therapeutic Committee' decided to restrict the use of vancomycin which was categorized into restricted antimicrobials, among general, reserved and restricted antimicrobials. The committee also established prescribing guidelines of vancomycin in Seoul National University Hospital, May, 1991. Especially, the restricted antimicrobials should be used after approval by infectious disease specialist physician. A retrospective drug use evaluation (DUE) on vancomycin has been conducted to compare with the previous vancomycin DUE study in 1990. 'Criteria for DUE on vancomycin' was modified from Am J Hosp Pharm. Total 65 charts of patients were retrospectively reviewed from July 1991 to June 1992 in Seoul National University Children's Hospital. The justification of use was improved from 56% to 75% comparing with the previous study. In analyzing process indicators, several criteria including body temperature monitoring, WBC monitoring and use of concomitant antibiotics were well documented, but serum creatinine monitoring, culture and sensitivity test and level monitoring were infrequently performed, while the accepted level has been improved. Accepted level for appropriate initial dosage and duration of therapy were decreased. In outcome analysis, blood culture after discontinuing the drug was relatively well documented compared with the previous study. As the results, the approval vancomycin use was shown to be effective and rational in antibiotic therapy. And it is suggested that the above findings should be communicated to the medical staff, and a active intervention, such as feedback control, also be necessary for rational drug use.

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BIM 기반 인허가신청 지원 시스템 개발 (Development of BIM-based Building Approval Submission System)

  • 유승은;김가람;김인한;유정호
    • 한국CDE학회논문집
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    • 제20권2호
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    • pp.171-181
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    • 2015
  • Building Information Modeling (BIM) provides many advantages when it is adopted in virtual design construction, to analyze constructability, etc. For this reason, advanced countries have made it mandatory to adopt BIM in public construction projects. The Korea Public Procurement Service announced that from 2016, BIM adoption will be mandatory in every construction project in Korea. Currently, however, it is not possible to fully adopt BIM in the building design process domestically because BIM-based systems have not been used broadly in Korea's building approval system (Seumter). In this research, four challenges were drawn from a focus group interview. Focusing on tackling one challenge, this paper reviewed previous research into building approval systems and the building approval systems of Singapore, the U.K. and the U.S., and identified elements of the building approval application process and presents a system to create and manage the information. The system supports the creation and management of information and 2D drawings from an IFC-based BIM model. We expect that the system will encourage designers to use BIM from the beginning of the design process and ultimately increase the efficiency of design in a BIM-based project.

Regulatory innovation for expansion of indications and pediatric drug development

  • Park, Min Soo
    • Translational and Clinical Pharmacology
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    • 제26권4호
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    • pp.155-159
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    • 2018
  • For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

R의 분류방법을 이용한 신용카드 승인 분석 비교 (A Comparison of Classification Methods for Credit Card Approval Using R)

  • 송종우
    • 품질경영학회지
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    • 제36권1호
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    • pp.72-79
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    • 2008
  • The policy for credit card approval/disapproval is based on the applier's personal and financial information. In this paper, we will analyze 2 credit card approval data with several classification methods. We identify which variables are important factors to decide the approval of credit card. Our main tool is an open-source statistical programming environment R which is freely available from http://www.r-project.org. It is getting popular recently because of its flexibility and a lot of packages (libraries) made by R-users in the world. We will use most widely used methods, LDNQDA, Logistic Regression, CART (Classification and Regression Trees), neural network, and SVM (Support Vector Machines) for comparisons.

건설CALS에서 고속도로인허가 시스템 구현 사례 (A Case Study on Implementing Highway Approval/Permission System in Construction CALS)

  • 윤주용;김민홍;이영재
    • 한국전자거래학회지
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    • 제4권3호
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    • pp.43-62
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    • 1999
  • This paper is to analyze business activities of approval/permission (A/P) and to describe its problems. To conduct the A/P business activities currently, there are many problems such as complex business process and different business policies among the each organization. In order to solve the problems, this paper suggests the A/P system of highway construction CALS (Commerce at Light Speed). CALS, a top down vision of complete computing integration, promises to support electronic data exchange. The A/P system is designed to classified documents based on CALS standard and store them to database. The data register to the A/P system by the Internet, and each construction company can use the A/P system by Internet also. Benefits of the A/P system is reduction in junk documents for approval/permission actives, improvement in conduct and services life cycle support.

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미국과 캐나다의 의약품 허가-특허 연계제도 (Drug Approval-Patent Linkage Systems in the US and Canada)

  • 박실비아
    • Journal of Pharmaceutical Investigation
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    • 제38권3호
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    • pp.207-215
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    • 2008
  • Drug approval-patent linkage is the practice of linking drug marketing approval to the patent status of the originator's product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. Article 18.9.5 of Korea-US Free Trade Agreement requires that Korea introduce the linkage system in drug marketing approval. However, Korea is unfamiliar with the linkage system. In addition, there have been lots of arguments over the impacts of this system on Korean pharmaceutical industry and pharmaceutical market in the future. This report investigated the linkage systems of the US and Canada. The US and Canada have implemented drug approval-patent linkage system since 1984 and 1993, respectively. Both countries have patent lists for drug approvalpatent linkage on which originators are required to list patents on substance, product, and use of their drugs. Generic or follow-on drug applicants must contain a certification regarding each patent listed that relates to the referenced drug. If the patent holder files suit for patent infringement within 45 days of notice of application, drug approval is not allowed for several months - 30 months in the US and 24 months in Canada. Both countries have amended their systems after having experienced unexpected results such as listing improper and additional patents, multiple patent litigations and delayed generic entries. After reviewing the US and Canada's experiences, we suggested three principles needed in implementing the system: protecting patent holder's right; promoting generic drug development and marketing; monitoring the process and the effect of the system.