• 제목/요약/키워드: regulatory guidelines

검색결과 163건 처리시간 0.026초

Identification and Analysis of the Legal Status of International Maritime Organization Instruments

  • Nam, Dong
    • 해양환경안전학회지
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    • 제27권3호
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    • pp.421-428
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    • 2021
  • Identifying which international maritime legal instruments are mandatory or recommendatory is complicated task even for maritime regulatory bodies. Although International Maritime Organization (IMO) had tried to ease the complexity by adopting guidelines on uniform wordings for making reference to other instruments in IMO parent conventions, there has still been some confusion identifying the mandatory status of IMO instruments. The aim of this study was to map out a step-based guideline to resolve the complexity of the mandatory status of IMO instruments to the maximum extent possible. This study reviewed the history of IMO rule-making process to find the root cause of the problem, then analyzed the approaches of regulatory enforcement bodies to check the practices. In conclusion, readers are directed to find such information as to legal status of IMO instruments and an improvement is proposed to enhance the transparency of information sharing for maritime industry to make better informed decisions.

An Analytical Appraisal of Building Information Modelling (BIM) Guidelines to Identify Variations in the Procedures

  • Das, Dakshata;Moon, Sungkon
    • 한국BIM학회 논문집
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    • 제6권3호
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    • pp.1-14
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    • 2016
  • The usage of Building Information Modelling (BIM) in building projects has enabled improvement in project planning, implementation and collaboration process amongst various stakeholders within architecture, engineering and construction (AEC) industry. However, variations exist in the current practices of BIM implementation and coordination process in the industry. These variations result in inconsistent degree of BIM use across the construction industry. This inconsistency gives rise to several managerial and technological challenges such as data interoperability issues and purposeful integration and exchange of information within the BIM components. In order to tackle the issue, it is essential to analyse the different BIM approaches employed by the industry practitioners. BIM guidelines serve as a critical link between the BIM model, and its subsequent execution. They therefore provide the best reflection of BIM application and processes. This research paper aims to address the variations existing in BIM practices across the construction industry. It includes an extensive study of 21 existing, publicly available BIM-based guidelines in order to establish an understanding of the present state of practice and deduce issues and concerns related to them. All guidelines analysed in this paper are first categorised based on authorship and the release date for efficient comparison. The points of similarity and difference between them are thereby realized and outlined. In addition, the transition of project implementation process from traditional methods to BIM technology is also explained. The existence of inconsistencies in the BIM guidelines reviewed in this paper reflects the need of a BIM 'Code Compliance Check'. The Code Compliance Check will serve as a regulatory project guideline that will further improve the potential of BIM by incorporating a consistent BIM modelling methodology for the entire construction industry.

원자력발전소 방호도장 Service Level 분류에 대한 고찰 (Study on Classification of Protective Coating Service Level in Nuclear Power Plant)

  • 임상준
    • 한국건축시공학회:학술대회논문집
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    • 한국건축시공학회 2018년도 추계 학술논문 발표대회
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    • pp.140-141
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    • 2018
  • Protective coatings at nuclear power plants should be designed to withstand exposure to ambient conditions during normal operation or design-basis accidents. However, there was a change in the perception of the protective coating to the revision of the Regulatory Guidelines by the NRC in July 2000. In other words, maintenance guidelines have been strengthened in order to minimize the clogging of the cooling water system due to the substances in the containment building. Therefore, KHNP, the contractor and operator of the nuclear power plant, plans to develop the coating system for nuclear power plants in accordance with the regulation, and plans to develop its own coating expert.

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Guidelines for Manufacturing and Application of Organoids: Lung

  • Kyungtae Lim;Mi-Ok Lee;Jinwook Choi;Jung-Hyun Kim;Eun-Mi Kim;Chang Gyu Woo;Chaeuk Chung;Yong-Hee Cho;Seok-Ho Hong;Young-Jae Cho;Sun-Ju Ahn
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.147-157
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    • 2024
  • The objective of standard guideline for utilization of human lung organoids is to provide the basic guidelines required for the manufacture, culture, and quality control of the lung organoids for use in non-clinical efficacy and inhalation toxicity assessments of the respiratory system. As a first step towards the utilization of human lung organoids, the current guideline provides basic, minimal standards that can promote development of alternative testing methods, and can be referenced not only for research, clinical, or commercial uses, but also by experts and researchers at regulatory institutions when assessing safety and efficacy.

Guidelines for Manufacturing and Application of Organoids: Heart

  • Hyang-Ae Lee;Dong-Hun Woo;Do-Sun Lim;Jisun Oh;C-Yoon Kim;Ok-Nam Bae;Sun-Ju Ahn
    • International Journal of Stem Cells
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    • 제17권2호
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    • pp.130-140
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    • 2024
  • Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

원전디지털자산 사이버보안 규제 요건 개발을 위한 보안조치 적용 방안에 대한 분석 (Analysis of the Application Method of Cyber Security Control to Develop Regulatory Requirement for Digital Assets in NPP)

  • 김인경;변예은;권국희
    • 정보보호학회논문지
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    • 제29권5호
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    • pp.1077-1088
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    • 2019
  • 원자력 발전소의 사이버위협이 현실화되면서 국제사회 및 국내에서는 사이버보안 규제지침 마련을 통해 필수디지털자산에 대한 적절한 보안조치를 적용하도록 요구하고 있다. 그러나 각 필수디지털자산에 대해 일괄적으로 동일한 사이버 보안조치 적용에 대해 규제 대상 내에서도 원전의 비상정지를 일으키고, 노심 손상을 유발할 수 있는 사고와 직접적으로 관련된 디지털자산에 단계적 접근방식을 적용한 규제 효과성 제고가 필요하다. 이에 본 연구에서는 원전 사고와 직접 관련된 디지털자산에 대하여 단계적 접근방식의 규제요건 개발을 위한 보안조치 적용 방안을 제시하였다. 단계적 접근방식의 기본적 고려사항인 규제 대상 설비의 침해영향도(Consequence)를 기반으로 한 규제 요건 적용을 위해 기존의 필수디지털자산에 요구되고 있는 보안조치를 보다 강화하거나 추가적인 보안조치를 개발하여 원전 사고와 직접 관련된 디지털자산에 요구하는 방식과 기존의 보안조치를 재분석하여 원전 사고와 직접 관련되지 않는 필수디지털자산에 대해서는 최소한의 보안조치를 요구하는 방식으로 크게 나누고 각 방안 별 세부적 사항을 기술하였다.

인터넷 의료광고의 규제방향에 대한 법적 검토 (Legal Review of Regulatory Guidelines for Medical Advertisements Online)

  • 이경권
    • 의료법학
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    • 제9권2호
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    • pp.269-308
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    • 2008
  • The contemporary age is a period of PR for the self. Regardless of how good the quality of goods or services offered is, if it is not made known to the buyers, a sell is impossible. As a result, the contemporary man is flooded with advertisements and is living in a time of over-saturated information. This is not much different in the medical services sector, as it too is experiencing an overflow of information due to the expansion of advertisement approaches to include not only the previous positive-method, but also the negative-method. In tandem, recent advancements in electronics and information technology has made possible a rapid increase in then number of internet advertisements. However, outmoded medical law, which was created to regulate newspapers and billboards, is still being applied to regulate today's modem medical advertisements. At the same time, collateral ordinances such as "corrective statutes for signs and advertisements" are not sufficient in providing the necessary regulatory countermeasures. In the midst of all this, as IPTV is scheduled to be broadcast nationwide starting next year, and with the market for search advertisements and internet advertisements annually growing at a rapid pace, it has become evermore urgent to come up with an adequate regulatory measure. Consequently, it is necessary to look into the possibility of restricting the medium and content of internet medical advertisements as well as realistic schemes for its realization. In particular, regulatory measures that take into consideration the special characteristics of internet advertisements should be found, and the necessity of an prior deliberation procedure and the likelihood of introducing a certification system should be examined.

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원전 사이버 보안 취약점 점검 도구 개발을 위한 규제요건 분석 (Regulatory Requirements Analysis for Development of Nuclear Power Plants Cyber Security Vulnerability Inspection Tool)

  • 김승현;임수창;김도연
    • 한국전자통신학회논문지
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    • 제12권5호
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    • pp.725-730
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    • 2017
  • 원전의 안전 유지를 위한 계측제어계통에 일반적인 IT 자원을 활용하는 사례가 증가하고 있다. 이에 따라 기존 IT 자원이 갖는 잠정적인 보안 취약점으로 인해 원전 사이버 보안 침해 사고가 발생할 수 있으며, 원전의 가동 중단뿐만 아니라 국가적 재난에 이르는 심각한 사고를 야기할 수 있다는 문제가 제기되고 있다. 국내 원자력 규제기관에서는 이에 대응하기 위해 원전 사이버 보안 규제지침을 개발하고 규제 대상 및 범위를 확대시키고 있지만, 원전의 일반적인 보안 문제뿐만 아니라 원전 취약점에 특화된 공격에도 대응할 수 있는 방안이 필요하다. 이에 본 논문에서는 R.G.5.71에서 규정하고 있는 내용 중 취약점 점검과 관련된 42개 항목을 선별하여 5가지의 유형으로 분류 분석하였다. 제안된 분석 내용을 바탕으로 취약점 점검 도구를 개발한다면 원전 사이버 보안 취약점 점검 효율성을 향상시킬 수 있을 것으로 판단된다.

Work-Related Stress Risk Assessment in Italy: A Methodological Proposal Adapted to Regulatory Guidelines

  • Persechino, Benedetta;Valenti, Antonio;Ronchetti, Matteo;Rondinone, Bruna Maria;Tecco, Cristina Di;Vitali, Sara;Iavicoli, Sergio
    • Safety and Health at Work
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    • 제4권2호
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    • pp.95-99
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    • 2013
  • Background: Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. Methods: After close analysis of the Italian and European reference regulatory framework and workrelated stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. Results: We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. Conclusion: This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

치과의사 자율규제 논의를 위한 해외 치과의사관리기구 검토 -국제치과의료인관리협의회, 영국, 캐나다 온타리오주, 미국 캘리포니아주, 호주, 일본을 중심으로- (Review of overseas dental regulatory authorities for a discussion on self-regulation of the dentist : Focused on International Society of Dental Regulators, the U.K., Ontario in Canada, California in the U.S. and Japan)

  • 김경일;하세가와 사오리;김형성;최규진
    • 대한치과의사협회지
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    • 제57권3호
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    • pp.124-148
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    • 2019
  • Recently, there has been an increasing interest in the regulation of medical & dental profession in South Korea due to various medical scandals & exacerbated commercialism. Consequently, the voice asking for strengthening the license management of medical & dental profession is rising. However, there is an absolutely lacking discussion on self-regulation of the Korean dentist community. This study investigated International Society of Dental Regulators and dental regulatory authorities in the U.K., Ontario in Canada, California in the U.S. and Australia. In addition, this study examined what situations Japan was in, which was similar to Korea in terms of systems. In the U.K., the U.S., Canada and Australia, there are independent dental regulatory authorities, which place emphasis on lay personnel participation. In addition, the organizations prepared very specific and detailed ethics, standards, and punishment guidelines to be followed by professionals. And, various efforts are being made to secure transparency and trust. As a result of this study, self-regulation in Korea seems to require an open approach that embraces civil society, and it is considered that dentist should lead social discussion more positively.

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