• 한국항해항만학회:학술대회논문집
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• 한국항해항만학회 1995년도 춘계학술발표회 논문집
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• pp.59-64
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• 1995

The impediment in enhancing the ship safety and combating vessel-source marine pollution depends on the combination of the immediate and mediate factors. The former is mainly caused by human errors and failure in compliance with the international convention standards in operation of compliance with the international convention standards in operation of vessel. The latter by the attitudes and activities of some of the flay states taking little responsibilities with appropriate seriousness in policing their fleets due to the lack of implementing capability of adminstrations. So long as there exists a large size of variation in implementing capability of administration between flag states a globally remarked progress cannot expect to be made in assuring the ship safety and preventing the vessel-source pollution Therefore a new regulatory regime is suggested to be adopted by IMO to maintain high standard flag state adminstrations by recommending standard paradigm to member states so that the development of a implementing culture is encouraged and supported.

• 품질경영학회지
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• 제34권1호
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• pp.54-72
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• 2006

In recent years, the widespread application of quality management and measurement reliability has put increasing emphasis on procedures for periodic instrument calibration. By optimizing calibration intervals, unnecessary calibrations can be minimized, thereby reducing costs. Moreover, optimizing intervals will improve compliance with regulatory directives while ensuring maximal compliance with reliability targets. In this paper, we present Calibration Interval Analysis Program developed using several establishment methodologies of calibration interval for measurement quality and reliability improvement. Also, we perform calibration interval analysis for some measurement instruments and analyse its results.

• 항공우주시스템공학회지
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• 제5권1호
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• pp.17-23
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• 2011

Since the time, cost and lack of regulatory information and guidance, one of the largest regulatory obstacles for an airframe manufacturer of polymer based advanced composite materials in certified aircraft applications, is to generate design allowables that will satisfy Airworthiness Regulations. In the past two decades, the design allowables used in military aircraft had been generated and applied in Korea, however the qualification of composite materials used in certifying airframe structure was not accomplished for design and demonstration of compliance to applicable airworthiness regulation. It is the intend of this paper that provide the basis of composite material qualification for small aircraft certification to the airworthiness regulation.

• 법제연구
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• 제53호
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• pp.213-267
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• 2017

핀테크 장벽 중 가장 두터운 것은 규제적 장벽인데, 이는 많은 기술 혁신가들이 줄곧 경험해 온 문제이다. 비록 기술적 솔루션들이 보다 저렴하고 안전한 금융서비스를 약속하지만, 핀테크 산업 내에서의 혁신을 가능하도록 하는 규제를 창설하는 것이 큰 과제이다. 특히, 핀테크 관련 사업자는 어느 특정한 규제보다는 관련 규제를 둘러싼 모호함과 혼란을 더큰 쟁점으로 받아들일 수 있다. 다수의 핀테크 모델들이 금융서비스 공급을 위해 새롭고 혁신적인 방식들을 지속적으로 도입하고 있기 때문에, 기존의 규제 및 법원칙을 적용함에 있어 상당한 혼란이 야기될 수 있으며, 또한, 대규모의 금융회사에 적용되는 복잡한 규제적 준법 모델들을 소규모의 신생 기업들(start-ups)에 적용시키는 것이 적정한지 여부도 문제이다. 이는 다수의 기존 규제와 원칙이 모바일 장치, 전자상거래, 인터넷 등을 고려하지 않고 수립 도입되었기 때문이기도 하다. 이에 핀테크 사업의 성장을 위해 규제 정보에 신속하고 저비용으로 접근할 수 있는 방안이 반드시 마련되어야 한다. 이러한 문제들에 대한 적절한 해답을 찾기위하여, 규제 기관, 기술 개발자, 그리고 금융소비자들의 상호 협력해야만한다. 다수의 금융당국들이 서비스 공급자들에게는 그들의 혁신을 테스트해볼 수 있는 기회를 제공하고 동시에 규제기관에게는 상품의 리스크를 파악할 수 있는 시간을 제공하는 규제 샌드박스(Regulatory Sandbox) 제도를도입하고 있다. 그러나, 자체적인 한계를 가진 규제 샌드박스의 도입만으로는 핀테크 혁신을 실질적으로 이루어지기에 충분한 환경을 창설하여주지는 못한다. 따라서 금융당국은 샌드박스에만 의존하기 보다는 핀테크생태계의 지원을 위하여 보다 포괄적이고 다면적인 노력을 하여야 한다.

• 한국콘텐츠학회:학술대회논문집
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• 한국콘텐츠학회 2010년도 춘계 종합학술대회 논문집
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• pp.345-346
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• 2010

기업은 개인정보의 보호를 위해 다양한 방안들을 마련해 이러한 규제를 준수하며 내부에 관리중인 개인정보에 대해 보안을 강화하기 위해 빠르게 보안 솔루션을 도입하고 있다. 이에 수많은 데이터들이 저장되어 사용되고 있는 DBMS 측면에서 이러한 규제를 준수하는 동시에 효과적으로 데이터 보안을 확보하기 위한 방안을 암호화, 접근제어, 감사로 구분하여 각각의 대한 구현방법 및 해당 솔루션들을 비교하여 이를 통해 최적의 데이터 보안 방안을 모색할 수 있도록 한다.

• 과학기술학연구
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• 제11권2호
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• pp.31-66
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• 2011

우리나라의 유전자변형식품에 관련된 사회 운동은 그동안 주로 표시제를 통해 소비자가 알권리와 선택할 권리를 보장해주어야 할 정부의 책임을 사회운동의 전면에 강조하는 방향으로 진행되었다. 실질적 동등성 개념에 기반을 두고 유전자 변형식품의 안전성을 평가하는 현행의 규제 방식에 대항적 전문성을 통하여 맞서고 비판하는 활동은 사회적으로 크게 확산되지 못하였다. 이 연구는 인터뷰와 문헌 조사를 통해 우리나라의 유전자변형식품에 관련된 논의에 참가한 세 그룹-규제 과학자, 시민단체, 대항 전문가-의 활동이 각각 현행 유전자변형식품 규제의 방식과 어떤 연관을 맺고 있는지 알아보았다. 대항 전문가들은 '국제기준 순응의 담론'의 생산자인 규제 과학자들과 충돌하면서 규제 형성의 과정에서 배제되었다. 이 연구는 우리나라의 유전자변형식품을 둘러싼 논란의 지형을 이해하기 위하여, 대항적 전문지식을 가진 행위자들이 다른 집단과 폭넓은 연대를 형성하지 못했던 과정과 맥락을 분석해 볼 필요가 있음을 제안한다.

• 수산경영론집
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• 제49권4호
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• pp.99-108
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• 2018

Maintaining a certain level of fisheries production is due to the increase in aquaculture production. In recent years, aquaculture plays an important role in fishery production in Korea. Nevertheless, aquaculture should be carefully managed by regulations because it also causes environmental load which can threat sustainability of aquaculture. For this reason, Korean government has regulated density of culturing facilities with the Fisheries Law and its adjective decrees. The regulatory compliance of fisheries businesses is very low because the criteria for the regulation of the density were not enacted with scientific research. Thus, this research was aimed to obtain scientific criteria for the regulation of oyster aquaculture in Jaran Bay with economic assessment. For this research, we collected the data necessary for the assessment on five investigation points in the bay for two years. With the data, simulation for the growth rate of oyster was performed and the result showed that at least 25.5% of facilities should be reduced. Also, it was revealed that removing 2 long lines would be most beneficial. The NPV of the best measurement was 35,120,300 won and IRR was 11.7%. With this research, the government will gain more accurate regulatory compliance due to the scientific approach. Moreover, fisheries businesses in oyster aquaculture can obtain flexibility to cope with market fluctuation.

• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.204-210
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• 2023

This study focuses on analyzing medical device standards and regulatory requirements in the medical device industry, based on the Medical Device Act in Korea. The objective of this analysis is to determine whether the domestic standards for medical devices in Korea align with international and regional standards. Furthermore, it aims to identify the current application of domestic standards in ensuring the safety and essential performance of medical devices. The analysis revealed that out of a total of 281 domestic standards, 127 standards reference international standards. In terms of the application of domestic standards to specific items, there were 473 types of instruments/machines, 30 types of medical supplies, and 45 types of dental materials. However, the level of compliance with international standards among the domestic medical device standards was only 21%. Upon detailed analysis, general and collateral standards accounted for 24%, while particular standards accounted for 19%. This indicates a significant deviation from the latest international standards. On the other hand, the level of compliance with international standards was analyzed to be 60% for particular standards and 72% for general and collateral standards in Korean industrial standards (KS). Considering these results, the disparities between domestic standards and international standards underscore the need for discussions on domestic medical device regulation and standardization. In conclusion, this study emphasizes the significance of maintaining up-to-date medical device standards and ensuring their alignment with international standards to ensure the safety and quality of medical devices. The findings highlight the necessity for further efforts to strengthen the domestic standardization system in order to promote the development of safe and high-quality medical devices.

• 한국임상약학회지
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• 제26권1호
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

• 통상정보연구
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• 제7권4호
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• pp.157-177
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• 2005

In many countries, a Single Window system for simplifications is establishing in order to reduce works submitted double data and compliance costs. A Single Window is defined as a facility that allows parties involved in trade and transport to lodge standardized information and documents with a single entry point to fulfil all import, export, and transit-related regulatory requirements. A Single window can bring improved level of security, faster clearance and reduced compliance costs. UN/CEFACT released "Recommendation and Guidelines on establishing a Single Window to enhance the efficient exchange of information between trade and government". Also, WCO has made progress several projects to assist effective establishing a single window, i.e. CDM, UCR, ICT. Korea has being established a single window system, "e-trade platform" connected with trade, clearance, logistics, marketing and payment system. Some suggestions to establish a effective single window system in Korea are as follows. Firstly, it is necessary to clearly define roles and responsibilities of a lead agency in a single window system and form a organic relationship with PGA. Secondly, a single window system has to be progressed by stages, namely, customs clearance portal system should be established first, and later established e-trade platform. Lastly, the Korean government has to take part in CDM project to gain an advantage over other countries.