• International Journal of Highway Engineering
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• v.13 no.1
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• pp.97-105
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• 2011

This paper presents how one can investigate the effects on crash occurrence of freeway geometric design elements including the horizontal, vertical alignment and road environment. At present, the available research results for the most part involve geometric data analysis that are obtained along a relatively long section of freeway, and, because of the long section's diverse geometric conditions, the results tend to miss the specific local geometric impacts on vehicle crashes. In this regard, this research attempts to establish vehicle crash models based on a set of freeway geometric patterns whose crash generating characteristics are identical because they are homogeneous in terms of producing the same vehicle operating speeds, and subsequently their actual relationships are described by providing statistical analysis made in this research. Also each standard is comprised of part of straight, curve and continuous curve. This research has revealed that each type of model has different relation between accident and geometry structure. This research results should be useful for doing more reasonable highway designs and safety audit analysis.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.196-203
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• 2006

Objectives : The aim of this study is to investigate how does the methods of treatment and diagnosis of Traditional Korean Medicine(TKM) get the evidence of efficacy and safety and what type of efficient body and appropriate facility of the coordination center for clinical trial in TKM. Methods : We have got the information of clinical trial center or clinical collaboration center by site invitation, search of paper and reports and internet exploration for the domestic or foreign site. Results : Coordination center for clinical trial usually involves every steps of clinical trials, such as development of Case Report From (CRF), design of study, calculation of sample size, randomization, maintenance of blinding, monitoring and audit of the resource document, data and CRF, data entry, quality control of data, analysis and report. Conclusions : The body needs several aresa of experts, which are epidemiologists, biostatisticians, research nurses for coordination, data manager and programmer, and administrator. This body would be enhance and help he clinical researches including clinical trials in TKM.

• Journal of the Society of Disaster Information
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• v.13 no.2
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• pp.139-146
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• 2017

This research verified that how citizen feel about police protection for the mass rally and how they trust about police and private security. Mass rally is lots of people gathering therefore, each of member could feel fear for their safe. And that kind fear has effect on success of rally Therefore we researched that security level by police and private security and the result is that most of people think that the charge of security is police and they think police member need to be more for their security. And police should be involved for the rally security. But they don't think for the private security.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2016.05a
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• pp.313-316
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• 2016

Highly probable cause of the current turmoil critical national infrastructure and private enterprise information systems failures or national event of an accident, it is inevitable huge hit in corporate business as well as a significant impact on the national benefit. This is a trend subject to the stability of the national management information system has a significant impact on people and society, such as banking, telecommunications, transport and energy, which can be extended into a private institution. However, public and private ICT business through the development of Information system Audit or CMMI(Capability Maturity Model Integration) certification check the quality of the target system, but quality check on the reliability of the information system operations after construction is either not promoting met for some safety test results a situation that does not enabled by insufficient. By preventing the disorder or an accident of this study, the diagnostic reliability information systems through inspection and evaluation system development of information systems being established, and to minimize service confusion and study ways to ensure customer - oriented service.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.403-411
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• 2007

The importance of pharmaceutical additives is increasing and the sorts and application categories are being classified in detail. International pharmaceutical council based on IPEC-America, IPEC-Europe and JPEC was established for specifications, safety and efficacy, approval regulations of pharmaceutical additives in 1992. Therefore, scrutinized examination of pharmaceutical additives used for already approved domestic drug was performed under the supervision of KFDA and nomenclature on application categories of pharmaceutical additives was summarized and endowed their glossary. Additionally, the boundaries of pharmaceutical additives according to the dosage forms based on the principle of the dosage forms of Korean pharmacopoeia were classified. These informations could be available for standards & experimental methods, approval, evaluation, audit of drug and contribution for national welfare.

• Health Policy and Management
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• v.32 no.3
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• pp.304-316
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• 2022

Background: As prevention of coronavirus disease 2019 (COVID-19) transmission in healthcare settings has become a critical component in its effective management, COVID-19 specific infection prevention and control (IPC) guidelines were developed and implemented by numerous countries. Although largely based on the current evidence-base, guidelines show much heterogeneity, as they are influenced by respective health system capacities, epidemiological risk, and socioeconomic status. This study aims to analyze the variations and concurrences of these guidelines to draw policy implications for COVID-19 response and future guidelines development. Methods: The contents of the COVID-19 IPC guidelines were analyzed using the categories and codes developed based on "World Health Organization guidelines on core components." Data analysis involved reviewing, appraising and synthesizing data from guidelines, which were then arranged into categories and codes. Selection of countries was based on the country income level, availability of COVID-19 specific IPC guideline developed at a national or district level. Results: The guidelines particularly agreed on IPC measures regarding application of standard precautions and providing information to patients and visitors, monitoring and audit of IPC activities and staff illnesses, and management of built environment/equipments. The guidelines showed considerable differences in certain components, such as workplace safety measures and criteria for discontinuation of precautions. Several guidelines also contained unique features which enabled a more systematic response to COVID-19. Conclusion: The guidelines generally complied with the current evidence-based COVID-19 management but also revealed variances stemming from differences in local health system capacity. Several unique features should be considered for benchmark in future guidelines development.

• The Journal of KAIRB
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• v.4 no.1
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• pp.5-15
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• 2022

To suggest future directions for the improvement in the Institutional Review Board (IRB) review process and efficient operation of IRB, we have analyzed the IRB review results from 460 new research proposals submitted to the Review by the Convened IRB of the Keimyung University Dongsan Hospital IRB from January 2019 to July 2021. IRB is an independently established institutional committee to protect the human subjects by reviewing the research protocol in ethical as well as scientific aspects, so it is necessary to continuously contemplate the ethical versus scientific dilemma of 'what is ethical or scientific and what can actually protect human subjects.' Particularly, in this process, it is necessary to consider diverse ways to strengthen self-supervision through continuous Internal Audit rather than simple reporting outcomes. In addition, if it does not directly affect the protection of the human subjects, the discussion with the committee members is needed so that the comments such as administrative and typographical errors can be reduced as much as possible. Furthermore, as statistical analysis methods can have a significant impact on the safety of human subjects, if a legal basis and/or support related to statistics is provided for the composition of IRB members, a more specialized IRB review will be achieved.

• Journal of Society of Preventive Korean Medicine
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• v.28 no.1
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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.

• Korean Security Journal
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• no.38
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• pp.7-32
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• 2014

This study is aimed to analyze problems of police budgetary execution and to suggest better ways for establishing effective budget implementation as well as legitimacy of securing budget in the field of police work. For this purpose, this paper analyzed the annual reports on police budgetary execution, from 2009 to 2012, conducted by National Assembly Budget Office. In result, most parts of the police budgetary execution were not satisfied with the audit standard, and especially in terms of management of budgetary execution, it showed 40% in inappropriateness. In addition, excessive and underestimate appropriation in the police budgetary execution, which happened frequently in other offices, was recorded on the second place. 10% of the amount of budget was executed for ordinance violence. Given results analyzed from each division, Transportation Division occupied 40% of the amount of related problems and all of types in the field did not meet the audit standard, thus it is required to manage budgetary execution effectively. In terms of Public Safety Division, the problem was related to budgetary allocation prior to execution, such as overlap in other works, excessive and underestimate appropriation, and inappropriate business plans. Director General for Planning and Coordination did not meet the standard of law system maintenance, Given the light of the result of analyzing programs, traffic safety and securing communication was the most problematic and support for police administration, crime prevention and protecting the disadvantaged, educating professional police officers, and establishment of policing infrastructure were required to be reformed in sequence. In order to resolve these problems, it is demanded to check budgetary execution and the process in business plans on a regular basis. Additionally, in case of using budget in inappropriate parts, tough penality including reduction of budget in related to the local police should be implemented to increase the importance of budgetary execution. Moreover, because of the fact that a part of problem of budgetary execution was originally caused by the budgetary allocation, it is advised to allocate police budget using the budget proposal of National Finance Act and Ministry of Strategy and Finance.

• The Korean Journal of Air & Space Law and Policy
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• v.29 no.1
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• pp.67-95
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• 2014

Some Contracting States of the Chicago Convention issue FAOC(Foreign Air Operator Certificate) and conduct various safety assessments for the safety of the foreign operators which operate to their state. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident. FAOC also burdens the other contracting States to the Chicago Convention due to additional requirements and late permission. EASA(European Aviation Safety Agency) is a body governed by European Basic Regulation. EASA was set up in 2003 and conduct specific regulatory and executive tasks in the field of civil aviation safety and environmental protection. EASA's mission is to promote the highest common standards of safety and environmental protection in civil aviation. The task of the EASA has been expanded from airworthiness to air operations and currently includes the rulemaking and standardization of airworthiness, air crew, air operations, TCO, ATM/ANS safety oversight, aerodromes, etc. According to Implementing Rule, Commission Regulation(EU) No 452/2014, EASA has the mandate to issue safety authorizations to commercial air carriers from outside the EU as from 26 May 2014. Third country operators (TCO) flying to any of the 28 EU Member States and/or to 4 EFTA States (Iceland, Norway, Liechtenstein, Switzerland) must apply to EASA for a so called TCO authorization. EASA will only take over the safety-related part of foreign operator assessment. Operating permits will continue to be issued by the national authorities. A 30-month transition period ensures smooth implementation without interrupting international air operations of foreign air carriers to the EU/EASA. Operators who are currently flying to Europe can continue to do so, but must submit an application for a TCO authorization before 26 November 2014. After the transition period, which lasts until 26 November 2016, a valid TCO authorization will be a mandatory prerequisite, in the absence of which an operating permit cannot be issued by a Member State. The European TCO authorization regime does not differentiate between scheduled and non-scheduled commercial air transport operations in principle. All TCO with commercial air transport need to apply for a TCO authorization. Operators with a potential need of operating to the EU at some time in the near future are advised to apply for a TCO authorization in due course, even when the date of operations is unknown. For all the issue mentioned above, I have studied the function of EASA and EU Regulation including TCO Implementing Rule newly introduced, and suggested some proposals. I hope that this paper is 1) to help preparation of TCO authorization, 2) to help understanding about the international issue, 3) to help the improvement of korean aviation regulations and government organizations, 4) to help compliance with international standards and to contribute to the promotion of aviation safety, in addition.