• Journal of the Korean Society for Marine Environment & Energy
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• v.11 no.4
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• pp.214-220
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• 2008

The Ballast Water Management Convention provides that ballast water treatment systems which make use of active substances shall be approved from IMO according to the procedure developed by the IMO. The Convention described that active substance means a substance or organism, including a virus or a fungus, that has a general or specific action on or against harmful aquatic organisms and pathogens. The Marine Environment Protection Committee of IMO gave basic approval to 13 ballast water management systems and final approval to 4 systems until October 2008. This paper considered the matter of procedure and documents of the basic and final approval based on the "Procedure for approval of ballast water management systems that make use of Active Substances (G9)" and "The Methodology for information gathering and the conduct of work of the GESAMP-BWWG" and summarized the specifications of the treatment systems which was granted the basic or final approval from IMO and raised several points.

• Fire Science and Engineering
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• v.20 no.3 s.63
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• pp.54-64
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• 2006

Rapid development of Information Technology(IT) requires new changes in overall official sections, and government also makes effort to promote the productivity and efficiency of official sections with IT. Objectives of this research are to evaluate the management of Electronic Approval System and to present the efficient way of using Electronic Approval System. In this research, we presented that the efficient use of Electronic Approval System requires systematic education, improvement of approval procedure, stability of system, improvement of system operation speed and connection with other official department.

• Journal of Applied Reliability
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• v.15 no.1
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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.

• Journal of the Korea Institute of Information and Communication Engineering
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• v.10 no.11
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• pp.1983-1988
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• 2006

There are gradually built on electronic commerce and business information system for the effective and automated use of internet while the mainstream of industry moves on information. It is necessary that a company should develop a electronic approval system because the business documents have application to an electronic commerce, business information system as well Currently, electronic approval system on groupware is using the way of inserting the image of an approval signature, which is vulnerable on a security by attacks of fraudulent use of electrical signature and eavesdropping on electronic documents. In this paper, we implementation XML form generator based on DTD having business documents structure for creating a valid business XML documents. we designed electronic approval system based on secured XML which transfers encrypted documents. For the security issues of written XML business documents, it makes use of the crypto algorithm having high performance transaction by the interchange of public key between a server and a client.

• Quality Improvement in Health Care
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• v.1 no.1
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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.

• Korean Journal of Computational Design and Engineering
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• v.20 no.2
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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.

• Translational and Clinical Pharmacology
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• v.26 no.4
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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.

• Journal of Korean Society for Quality Management
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• v.36 no.1
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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.

• The Journal of Society for e-Business Studies
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• v.4 no.3
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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.

• Journal of Pharmaceutical Investigation
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• v.38 no.3
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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.