• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Asian Journal of Business Environment
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• 제8권2호
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• pp.5-13
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• 2018

Purpose - The aim of this study is to investigate the problems, challenges, opportunities and future prospects of Islamic banking and finance in the UK. However, this study brings forward into 3 main purposes. Firstly, to explore the development of financial institutions, products and regulatory reforms. Secondly, to find out the performance of Islamic banking institutions. Lastly, to identify the problems, challenges and Islamic banking future prospects. Research design, data, and methodology - An in-depth literature review was carried out to fulfil the research objectives. Results - The findings point out the basic problems of Islamic banking industry in UK such as unfavorable regulatory environment, unfamiliarity with the Islamic Banking System, lack of portfolio management, absence of liquidity instruments, in need of professional bankers, and blending of approach of Islamic scholars with the approach of the conventional bankers. The findings also indicate that there are greater opportunities in the UK for development and growth of Islamic financial system because Muslim community is eager to take financial products. Conclusions - It is hoped that issues pertaining to Islamic banking products can be resolved through consensus of Shariah scholars. There is need to educate the Muslim community about Islamic financial products and service.

• 약학회지
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• 제57권3호
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• pp.173-186
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• 2013

To ensure the safe use of pharmaceuticals in the market, US, EU and Japan reached a consensus to adopt ICH harmonised tripartite guideline "E2E Pharmacovigilance Planning" in 2004. Subsequently these regions established and implemented new pharmaceutical safety management systems for patients based on ICH E2E guideline and Risk Evaluation and Mitigation Strategy (REMS) in US or Risk Management Plan (RMP) in EU and Japan. In this study we investigated these new foreign systems and suggested a way to improve Korea's regulatory system for pharmaceutical safety management under Korea Pharmaceutical Law in the view of international harmonization.

• 한국방사성폐기물학회:학술대회논문집
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• 한국방사성폐기물학회 2017년도 추계학술논문요약집
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• pp.21-22
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• 2017

• 아태비즈니스연구
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• 제13권3호
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• pp.227-243
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• 2022

Purpose - This study surveyed real estate financial consumers and financial company staff regarding the components of the financial consumer protection system to seek detailed improvement plans for the Financial Consumer Protection Act. Design/methodology/approach - The Analytic Hierarchy Process (AHP) technique is applied. Findings - Both consumers and staff highly evaluated the importance of the preventive measures in the main classification factors. Regarding the sub-classification factors of preventive measures, consumers emphasized the responsible management of investment staff and financial institutions; however, the staff stressed the principle of effectiveness and efficiency. Regarding the elements of ex-post remedies, consumers answered that fast remedy would have a significant effect. At the same time, staff believed that punitive measures hinder free trading and investment activities. Regarding the sub-sub classification factors of prevention measures, the consumers value responsible management of staff and financial companies, while the staff tend to prefer the importance of the self-regulatory governance. Research implications or Originality - Based on the above results, financial regulatory authorities should find a balance between preventive and ex-post components once focusing on preventative measures. Our paper is one of the first research findings in this field of financial consumer protection system in Korea.

• 대한기계학회:학술대회논문집
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• 대한기계학회 2003년도 춘계학술대회
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• pp.610-616
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• 2003

Recently, the common concern of nuclear power industry in the development of technology mitigating and preventing the aging of steam generator tubes prevails, because the trends of steam generator flaws at Uljin unit #1,2 and KSNP(Korea Standard Nuclear Power Plant) impose a burden on the operation of nuclear power plant. While the regulatory agency is demanding the establishment of the advanced general performance maintenance system, the steam generator management program adapting advanced technology is being developed which may comply with EPRI PWR SG Guidelines based on NEI 97-06 ‘ General Guidelines including all the maintenance aspects consist of the tube integrity assessment criteria, repair limit, allowable leakage level, water chemistry will be composed in order to obtain the approval of regulatory agency and be applied to Nuclear power plant early 2005. This presentation is to introduce maintenance state including SG tube degradation and main contents of advanced SG management program being developed, and futhermore update present and future plan, and estimate the alternation after the completion.

• 한국ITS학회 논문지
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• 제19권2호
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• pp.1-17
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• 2020

본 연구는 자율주행 시대에 대비하여 기존의 인간 운전자 대상의 교통규제의 변화를 모색하기 위해, 기존 교통안전시설 규제정보 공공개방을 위한 기초 인식조사 연구를 수행하였다. 이를 위해 자율주행차 관련 정보 수요자 집단, 현행 교통규제정보 관련 정보 관리자 집단을 대상으로 전문가 심층면접(In-depth Interview, IDI)을 수행하여 교통규제정보 공공개방의 방향성을 확인하였다. 분석 결과, 동적 규제정보에 대한 체계적 제공, 정보의 신뢰성 향상, 일원화된 정보 관리 체계에 대한 필요성을 확인하였으며 자율주행차의 주행에 대비한 IoT 기반의 교통안전시설 도입에 대한 요구사항을 도출하였다. 또한 서비스 제공을 위한 관리기관 및 수요기관 간의 유기적인 협업체계가 필요함을 확인하였다.

• International Journal of Computer Science & Network Security
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• 제21권12spc호
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• pp.477-482
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• 2021

The existing approaches to ensuring the banking security of the state do not take into account the peculiarities of the banking system in the rapid development of the information economy (increasing uncertainty, imbalance and nonlinearity of processes in the banking system under the influence of innovation, institutions, information asymmetry, etc.). A methodological approach to determining the synergetic effect in the implementation of the regulatory influence of the state on the development of innovation processes related to informatization in the banking system, based on the use of differential equations and modelling the sensitivity of innovation processes related to informatization in the banking system, to the regulatory influence of the state to prevent the deployment of risks and threats to economic security of the state in this area has been suggested in the present article.

• 한국항공운항학회지
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• 제23권2호
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• pp.57-62
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• 2015

As the issuance of type certificate and production certificate for KC-100 Naraon, Korea is ranked as the State of Design and the State of Manufacture for civil aircraft specified in the Convention on International Civil Aviation. It means that another responsibilities are imposed and new frameworks are required for the airworthiness management including the continuing airworthiness. So far the minimum airworthiness management system was sufficient as the State of Registry for the aircraft operations and safety management. However, we need to establish and maintain the airworthiness management system for the effective certification and oversight of our air operators and approval holders. This paper introduces the new obligations under the Convention on International Civil Aviation, reviews the current aviation regulations and procedures and presents the strategy for the establishment of the regulatory system to ensure the airworthiness of aircraft.

• 해양환경안전학회지
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• 제27권6호
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• pp.737-743
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• 2021

본 논문에서는 해양산업시설 현황과 규제법규 체계, 그리고 이들 시설의 위험유해물질 배출실태 등을 분석하고, 이에 따른 규제체계의 개선방향을 제시하였다. 분석결과 2020년말 현재, 해양환경관리법의 적용을 받는 해양산업시설은 약 1천1백여개소에 이르는 것으로 파악되고 있다. 이들 해양산업시설로부터 배출되어 해양유입 가능성이 높은 위험유해물질은 190여종으로 추정되며, 이중 해양유입의 가능성이 가장 높은 물질은 수계로 배출되는 것으로 파악된 20여종으로 추정된다. 그러나 관련 법규정의 미비로 인하여, 배출되는 물질이 예외적 배출물질에 해당하는지 여부를 명확히 판단하기가 어려워, 현장에서의 효과적인 규제집행에 어려움을 겪고 있는 실정이다. 이에 해양환경관리법의 예외적 배출기준과 해당 물질의 종류에 대해 명확히 규정해야 하며, 예외적 배출물질을 무엇으로 할 것인지를 결정할 선정체계와 물질의 위해성 평가체계, 그리고 관련 위험유해물질의 배출정보수집 및 모니터링체계를 명확히 해야 한다.