• 제목/요약/키워드: regulatory agency

검색결과 201건 처리시간 0.025초

A Review on Mutagenicity Testing for Hazard Classification of Chemicals at Work: Focusing on in vivo Micronucleus Test for Allyl Chloride

  • Rim, Kyung-Taek;Kim, Soo-Jin
    • Safety and Health at Work
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    • 제6권3호
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    • pp.184-191
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    • 2015
  • Chemical mutagenicity is a major hazard that is important to workers' health. Despite the use of large amounts of allyl chloride, the available mutagenicity data for this chemical remains controversial. To clarify the mutagenicity of allyl chloride and because a micronucleus (MN) test had not yet been conducted, we screened for MN induction by using male ICR mice bone marrow cells. The test results indicated that this chemical is not mutagenic under the test conditions. In this paper, the regulatory test battery and several assay combinations used to determine the genotoxic potential of chemicals in the workplace have been described. Further application of these assays may prove useful in future development strategies of hazard evaluations of industrial chemicals. This study also should help to improve the testing of this chemical by commonly used mutagenicity testing methods and investigations on the underlying mechanisms and could be applicable for workers' health.

Issues and Vision of Korea Maritime Police

  • Lee, Sangjib
    • 해양환경안전학회:학술대회논문집
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    • 해양환경안전학회 2000년도 International Symposium:on the Maritime Management Systems for Safer and Cleaner Seas in the New Millennium
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    • pp.14-25
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    • 2000
  • Should the Korea Maritime Police Agency (KMPA) be a comprehensive, multi-functional organization for a unique on-scene service at sea, as in the case of the U.S. Coast Guard, or should it be simply a water police agency, confining its mission only to law enforcement? The argument about enlarging or limiting KMPA's function has been and will be repeated. In this paper, Lee Sangjib highlights the internal and external issues facing KMPA, stemming partly from deficiencies of its struggles for advancement of the organization and partly from shortcomings of political support for it. In this regard, he urges KMPA to practise a scientific management system for maximizing cost-effectiveness of its administrative resources and for maintaining its identity and characteristics as a lead maritime agency. In addition, he also suggests that KMPA adopt the Total Quality Management System for quality improvements in services and greater efficiency in its organization structure to meet the future competition in the changing political and legal environment. He further recommends the proactive, non-regulatory 'Prevention Through People' program, pioneered by the U.S. Coast Guard, as a way of changing KMPA's existing lopsidedly legalistic culture. He concludes by providing a 6-point vision statement for KMPA from the standpoint of favoring enlarging the function of KMPA.

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고준위 방사성폐기물의 국내철도운반에 관한 방사선영향 예비평가 (Preliminary Assessment of Radiological Impact on the Domestic Railroad Transport of High Level Radioactive Waste)

  • 서명환;도호석;홍성욱;박진백
    • 방사성폐기물학회지
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    • 제15권4호
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    • pp.381-390
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    • 2017
  • 국내 원자력발전소의 사용후핵연료는 소내저장시설에 보관되어 있으나 저장시설의 용량 확장이 어려움이 있으며, 연구기관의 연구로에서 발생하는 고준위 방사성폐기물도 자체 보관중이나 영구적으로 저장할 수 없다. 또한 원전의 해체 시에도 고준위 방사성폐기물이 발생할 것으로 예상된다. 이에 따라, 본 연구에서는 현재 개발된 사용후핵연료 운반용기를 사용하여 고준위 방사성폐기물을 가상의 관리시설로 철도를 통하여 운반하는 경우에 대하여 작업자 및 운반경로 주변 일반인의 예상 피폭선량을 평가하였으며, 그 결과를 국내 법적기준치와 비교하였다. 또한, 고준위 방사성폐기물의 상하차 작업 시 작업자와 운반용기 간 거리와 운반사고 시 방사성핵종의 누출율의 변화에 따른 피폭선량의 변화에 따른 피폭선량 추이와 운반에 사용되는 열차의 구성에 따른 운반작업자의 피폭선량 변화를 분석하였다. 본 연구에서 설정한 모든 조건에서의 예상피폭선량은 국내 법적제한치 이하임을 확인하였다.

결합전문기관의 역할 확대를 위한 개선방안 (Improvement Plan to Expand the Role of Expert Data Combination Agency)

  • 김기범;권헌영
    • 정보보호학회논문지
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    • 제33권1호
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    • pp.99-116
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    • 2023
  • 데이터, AI 등 정보기술 기반의 초연결 사회인 4차 산업혁명 시대의 데이터 중요성이 증가하고 있으며 이에 발맞추어 정부도 데이터경제 활성화를 위한 법률 제정 및 개정이 활발히 진행되고 있으나 규제 법률인 개인정보보법과 데이터 활성화 법률(데이터기반행정 활성화에 관한 법률, 데이터 산업진흥 및 이용촉진에 관한 기본법, 산업디지털 전환 촉진법) 간 충돌 가능성, 결합전문기관 유형별 입장차, 데이터전문기관과 결합전문기관의 수행 범위 등 데이터산업 활성화의 발목을 잡거나 잘못된 방향 설정 등의 문제를 예방하고 개선할 필요가 있다. 이에 결합전문기관의 역할 및 현황, 활용 사례를 분석하고 현장의견을 청취하여 데이터경제 활성화를 위한 결합전문기관 역할 확대 방안과 개선방안을 도출하여 소개하고자 합니다.

Institution for Regional Innovation System: The Korean case

  • Kang, Byung-Joo;Oh, Deog-Seong
    • World Technopolis Review
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    • 제4권2호
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    • pp.46-61
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    • 2015
  • There is an implicit assumption in most regional innovation policy studies that once a policy has been made the policy will be implemented. This assumption is not valid for regional innovation policies formulated in many countries. This assumption rests upon certain political and organization conditions. It is frequently said that regional innovation system in Korea is one of the successful cases because of properly established institution for the implementation of innovation policies. The components of institution for innovation are defined in this article. For the analysis of institution for regional innovation system in Korea, three aspects such as organization, policies & programs, and governance structure were taken into account. Institution for regional innovation system in Korea is analyzed with three aspects: (1) organization for policy implementation, (2) innovation policy, and (3) governance structure. Firstly, organizations for innovation in Korea are composed of three categories such as organizations for policy formulation, organizations for policy implementation and agencies for coordination. Secondly, there are two categories of policies for innovation: (1) policies for the enhancement of national competitiveness and policies for the regional innovation capacity building, and (2) policies for fostering manpower and policy for regulatory reform. Thirdly, innovation governance in Korea is composed of three layer structure: (1) top level governance which is composed of two committee, three ministries and two agencies, (2) local level governance such as one innovation related offices and one center for regulatory reform, and (3) one category of agency for coordination as a regional platform.

의약품 허가 후 발생하는 변경사항에 대한 EMEA 관리 지침 (Understanding Key Thrust of EMEA Post-Authorisation Guidance)

  • 사홍기
    • Journal of Pharmaceutical Investigation
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    • 제36권6호
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    • pp.421-435
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    • 2006
  • The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

Development and strengthening of the nuclear and radiation safety infrastructure for nuclear power program of Bangladesh

  • Islam, Md. Shafiqul;Faisal, Shafiqul Islam;Khan, Sadia
    • Nuclear Engineering and Technology
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    • 제53권5호
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    • pp.1705-1716
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    • 2021
  • Bangladesh, as a newcomer country, is expecting to start her nuclear power journey by 2022. Due to evident reasons, newcomer nuclear countries face several key challenges concerning the development of national nuclear safety infrastructure. The paper investigates the status of the 7 key safety infrastructure issues out of the 19 and readiness of the supportive organizations, laboratories, and workforces following the International Atomic energy Agency's status evaluation guide at milestone 3 and foreign countries' practice. Much progress has been achieved at phase 3 regarding the establishments of a few Acts, a regulator, and an operator. However, comprehensive regulatory frameworks, skilled workforces, establishments of a few supportive organizations, and laboratories for managing environmental radioactivity, radiological accidents, and radioactive wastes are yet to ready. Several suggestions are made for establishing and expediting radiation monitoring laboratories, a radiological emergency management center, a radioactive waste management company, and technical support organizations for the safety infrastructure. To avoid perceived risks, policymakers and competent authorities need to emphasize creating an optimized safety infrastructure before commissioning and operating the 1st nuclear power plant safely, securely, and cost-sustainably.

Ensuring the Quality of Higher Education in Ukraine

  • Olha Oseredchuk;Mykola Mykhailichenko;Nataliia Rokosovyk;Olha Komar;Valentyna Bielikova;Oleh Plakhotnik;Oleksandr Kuchai
    • International Journal of Computer Science & Network Security
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    • 제23권11호
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    • pp.142-148
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    • 2023
  • The National Agency for Quality Assurance in Higher Education plays a crucial role in education in Ukraine, as an independent entity creates and ensures quality standards of higher education, which allow to properly implement the educational policy of the state, develop the economy and society as a whole.The purpose of the article: to reveal the crucial role of the National Agency for Quality Assurance in Higher Education to create quality management of higher education institutions, to show its mechanism as an independent entity that creates and ensures quality standards of higher education. and society as a whole. The mission of the National Agency for Quality Assurance in Higher Education is to become a catalyst for positive changes in higher education and the formation of a culture of its quality. The strategic goals of the National Agency are implemented in three main areas: the quality of educational services, recognition of the quality of scientific results, ensuring the systemic impact of the National Agency. The National Agency for Quality Assurance in Higher Education exercises various powers, which can be divided into: regulatory, analytical, accreditation, control, communication.The effectiveness of the work of the National Agency for Quality Assurance in Higher Education for 2020 has been proved. The results of a survey conducted by 183 higher education institutions of Ukraine conducted by the National Agency for Quality Assurance in Higher Education are shown. Emphasis was placed on the development of "Recommendations of the National Agency for Quality Assurance in Higher Education regarding the introduction of an internal quality assurance system." The international activity and international recognition of the National Agency for Quality Assurance in Higher Education are shown.

원자력 규제기관의 SNS 활용 및 수용자 반응 분석 : 원자력안전위원회와 NRC 페이스북 비교를 중심으로 (An Analysis on SNS Management and Visitors' response of Nuclear Regulatory Organizations : Focus on the Comparison about facebook page between NSSC and NRC)

  • 최현주;심은정
    • 디지털융복합연구
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    • 제14권5호
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    • pp.11-19
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    • 2016
  • 최근 SNS 사용자가 증가함에 따라 정부부처의 홍보에도 SNS가 주요 홍보채널로 등장하였다. 특히 리스크를 관리하는 데 있어서 SNS는 유용한 도구이자 새로운 도전 과제가 되었다. 우리나라에서 원자력은 주요한 리스크 중 하나이며, 원자력 규제기관이 국민과 어떻게 소통하고 있는가는 원자력시설에 대한 신뢰 혹은 수용성에 매우 주요한 영향을 미칠 수 있다. 이를 반영하여 본 연구는 한국(NSSC)과 미국(NRC) 양국의 원자력규제를 담당하는 정부부처의 SNS 활용과 수용자 반응을 비교 분석했다. 연구 결과, 양 기관 모두 '정보제공'목적의 포스팅이 가장 많았으며, PR유형의 경우 한국은 '관계관리 PR', 미국은 '이미지 PR'의 포스팅이 많았다. 수용자 반응을 살펴보면 참여형과 비주얼형(동영상, 카드뉴스, 인포그래픽 등)의 포스팅에 수용자들의 반응이 높았으며, 관계관리 PR에 대한 수용자 반응이 더욱 높았다. 이러한 연구 결과가 향후 정부부처 정책을 소통 전략을 수립하는데 있어 도움이 되길 기대해 본다.

연구 실험실 안전보건 관리제도 비교 - 한국과 독일 사례 고찰 (Comparison of Regulatory Systems for Safety and Health Management in Research Laboratories - Case Review between Korea and Germany)

  • 박지훈;성백경;마티아스 올리버 알트마이어;김용준
    • 한국산업보건학회지
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    • 제30권2호
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    • pp.99-108
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    • 2020
  • Objectives: This study aimed to compare the regulatory systems for laboratory safety and health management between Korea and Germany and discuss the implications. Methods: Laboratory safety and health regulations for legal enforcement and relevant technical guidelines in Korea and Germany were reviewed. Results: Lab safety and health management is enforced by the Act on the Establishment of Safe Laboratory Environment in Korea. Most provisions focus on supervisory control, that is, the principal's liability is emphasized. In addition, there is a lack of laboratory-specific procedures for safety and health management in the act since it is stipulated that other relevant regulations apply to some technical contents. Non-compulsory technical guidelines for lab safety and health management are also provided by the Korea Occupational Safety and Health Agency (KOSHA) in order to enable researchers to follow safe procedures. There is no independent regulation for lab safety and health in Germany, and it is also governed by several regulations. The German Social Accident Insurance Institute provides technical guidelines on lab safety and health, and these contain more specific content to allow them to be followed more easily compared to the KOSHA guidelines. The most remarkable differences between the regulation of each country were contents of the risk assessment and specific protect measures from hazardous agents. Conclusions: Regulatory control is an essential way to prevent accidents, but it is more important to create an environment in which all stakeholders, including individual lab members, are allowed to participate actively in safety and health management activities.