• 한국항공운항학회지
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• 제22권4호
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• pp.115-125
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• 2014

Ground-Based Augmentation System (GBAS) is providing precision approach and landing service with aircraft around airport. FAA granted System Design Approval (SDA) of SLS-4000 to Honeywell as the first GBAS category I system on September 2009. Since then, according to their own kind of approval process including System Design Approval, Facility Approval and Operational Approval, USA, Germany, Spain and Australia have approved GBAS category I system which are installed in some airports in order to provide commercial GBAS service. Recently, KARI has also installed GBAS category I system into Gimpo international airport to establish operational technology of GBAS domestically and to validate effectiveness of GBAS system in Korea. This paper introduces overseas trends and activities regarding approval process of GBAS system and presents approval process and criteria appropriate for future commercial operation of GBAS in Korea.

• 한국정보통신학회:학술대회논문집
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• 한국해양정보통신학회 2001년도 춘계종합학술대회
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• pp.532-536
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• 2001

WTO체제에서 정보통신표준화 분야의 국제규범 역할을 담당하고 ITU-T는, 이 분야에 대한 신속한 표준화 요구 등 변화하고 있는 환경을 고려하여, 최근 표준승인절차를 개정하고 민간 산업체의 참여를 적극 유도하고 있다. ITU-T의 새로운 표준승인절차는 초안이 성숙된 후 승인까지 최소 2개월 정도로 단축함으로써, 짧아진 기술 수멍주기에 대응하고 있다. 아울러 ITU에서는 기술적 표준화에 대한 민간의 결정권을 둘러싸고 이를 개선하기 위한 논의가 현재 진행중에 있다. 이는 기존의 ITU가 가지는 국제규범으로서의 위치를 유지하면서 민간의 역할을 더욱 강화하려는 것으로 현재 시행중에 있는 새로운 표준 제정절차와도 관계되어 있다. 본 글에서는 새로 제정되어 시행되고 있는 표준승인절차(AAP ; Alternative Approval process)를 단계별로 분석하고 이에 대한 우리나라 및 민간의 참여에 대한 대응책을 제시함과 아울러 현재 진행중인 ITU 개혁에 대한 논의를 소개함으로써 표준화 방향 설정에 대한 토대를 제시코자 한다.

• 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.

• 국제학술발표논문집
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• The 6th International Conference on Construction Engineering and Project Management
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• pp.664-664
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• 2015

Advanced countries have mandated applying BIM in construction projects. Also, Public Procurement Service has planned to mandate applying BIM to all construction project that ordered in PPS from 2016 in KOREA. However, now Seumter that is building administration system is not supported BIM based construction license BIM information from Seumter. Thus, despite the applicant is preparing a BIM model, they do not take advantage of BIM information in Seumter. In previous studies. We developed a BIM based building approval submission system. In this study, we verified the system that developed in previous research. As a result, requirement information input time reduction in Seumter system showed high satisfaction. But there was as low usability because building approval submission system cannot support some information for building approval in seumter. If the system will do utilization and management with the building approval system, the applicant can be using BIM base design document information and saving the time that takes at building approval submission. Study about the system improvement is required for application to building approval system.

• 국제학술발표논문집
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• The 1th International Conference on Construction Engineering and Project Management
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• pp.731-736
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• 2005

The governmental attitude toward private investment and financing for infrastructure projects has changed from the initial prohibition to the current encouragement in China, which has been embodied in the legal documents and administrative process. However, the problem of identification, bidding, and approval procedure for privately financed infrastructure projects has been observed in policies and administrative measures promulgated by different or even the same government branches, which is prohibitive factors for smooth project implementation. After analysis of the identification, bidding, and approval process of infrastructure projects, the authors proposed a simplified and alternative procedure and clarified the key points of relevant project documents.

• 산업공학
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• 제12권1호
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• pp.79-93
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• 1999

As most of information systems developed are data-centric rather than process-centric, it is difficult for users to understand and manage the system from the viewpoint of work processes. To resolve the problem of the data-centric design, we propose a new method to design WFMSs(Workflow Management Systems), which are focused on processes and modified from current information engineering methods. In this research, the drawing approval and engineering change approval process of a K manufacturing company has been analyzed as a sample process. This method takes two steps, i.e., process analysis and system design. In the prosess analysis, data and processes are analyzed, and functions and tasks are derived from the processes. In the system design, a data model for the operation of WFMS is designed, and based on this data model, build-time and run-time functions of WFMS are designed.

• 대한예방한의학회지
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• 제28권1호
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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• pp.22-24
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• 2003

This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

• 한국임상약학회지
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• 제28권4호
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• pp.263-272
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• 2018

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

• 연구논문집
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• 통권30호
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• pp.169-176
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• 2000

The Evolution of Workflow Managment consists of rhe automation of business procedures or "workflows" during which documents, information or tasks are passed from one participant to another in a way that is governed by rules or procedures. Workflow technologies have evolved from image management system, document management system, relational or object database systems, and electronic mail system. Workflow Management system has the benefits to improve better efficiency, process control,flexibility, business process. Automation of many business processes results in the elimination standdardizing working methods. Consistency in the processes leads to greater predictability in levels of response to customers and software control over processes enables their re-design in line with changing business needs, In this present study, we implement Electronic Approval System which is a kind of Workflow Management system using static and dynamic flow control information on the web environment.