• International Journal of Stem Cells
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• 제17권2호
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• pp.102-112
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• 2024

An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1997년도 추계학술대회
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• pp.57-74
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• 1997

To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

• 환경영향평가
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• 제23권3호
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• pp.227-235
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• 2014

Interest has been growing worldwide in unconventional natural gas that has become an increasingly important source of energy in the world. Unconventional gas development, including shale gas, generally involves a larger environmental impact, compared to conventional gas development, due to its intensity and scale of the operation. There are a growing number of studies on identifying and minimizing the environmental impacts of unconventional gas development. This study aims to examines the current environmental policies and regulatory systems related to the unconventional gas development. The study shows that few environmental regulation exists concerning unconventional gas development, even in the USA where unconventional gas development is most actively pursued. Regulations, however, are being developed based on studies currently underway on health and environmental risks of unconventional gas development and on guidelines designed to reduce the risks. In a world where environmental regulations are ever strengthening, review the environmental regulatory systems and guidelines about unconventional gas need to be established for Korean firms to understand environmental impacts of unconventional gas development they invest or take part in, enabling them to manage and operate gas activities in a way that minimizes environmental damages.

• Asian Journal of Business Environment
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• 제7권2호
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• pp.5-16
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• 2017

Purpose - The purpose of this research study is to make a comparative analysis between corporate governance guidelines 2016 and 2012 and area of further improvement to ensure better governance, accountability and transparency. Research design, data and methodology - This research study is mainly based on the corporate governance guidelines 2016 and 2012 issued by the regulatory authority known as Bangladesh Securities and Exchange Commission (BSEC). Results - This study finds that corporate governance guideline 2012 include some new issues such as criteria and qualification of independent director; some additional statements in the directors' report; mandatory requirement of separation of chairman and CEO; constitution of audit committee; chairman of audit committee; role of audit committee, duties of CEO and CFO on financial statements; and collection of compliance certificate from professional accountant or secretary in compare to corporate governance guidelines 2016. Conclusions - This study suggests that the regulatory authority should include more issues such as tax management and reporting, risk management and reporting; individual and overall performance analysis of the board and independent directors; separate nomination and compensation committee; assessment of true independence of the board and its supporting committees to ensure higher quality of corporate governance and transparency.

• 대한조선학회논문집
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• 제46권2호
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• pp.179-188
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• 2009

WIG crafts are a high speed vessel with features of dynamic supported craft. These crafts, which are predominantly of light weight and operate any substantially greater speeds than conventional craft such as bulk carrier, tanker, container ship, etc., could not be accommodated under traditional maritime safety instruments. It means that there is the need for risk and safety levels to be assessed on a holistic basis, recognizing that high levels of operator training, comprehensive and thoroughly implemented procedures, high levels of automation and sophisticated software can all make significant contributions to risk reduction. To response this requirement, the Interim Guideline for WIG craft(MSC/Circ.1054) were developed in the view of the configuration of WIG craft, which fall between the maritime and aviation regulatory regimes. This paper reviews a safety assessment process and methodology to be used in the design phase of a new ship. The process and methodology is based on the risk-based approach and is applied to safety assessment in concept development phase of small WIG craft in the 20-person class.

• 한국산업보건학회지
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• 제34권2호
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• pp.148-155
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• 2024

Objectives: Among the regulations that have recently attracted a lot of social attention in Regulation on Occupational Safety and Health Standards, we would like to specifically present the reasons why even companies with strong will to comply with regulations that are not effective or entail a number of legal problems, and suggest ways to improve them. Methods: The facts were confirmed and identified through various methods such as interviews and meetings with labor inspectors who enforce the Regulation on Occupational Safety and Health Standards and safety officials at industrial sites experiencing them. Results: Due to the lack of effectiveness in Regulation on Occupational Safety and Health Standards, there are not a few areas that do not function properly as a preventive standard. Although operating the regulatory nature of punishment as an administrative guideline without basing it on Regulation on Occupational Safety and Health Standards is a direct violation of the principles of the administration of the rule of law, there are many expedient ways to replace what should be placed in this rule as just an administrative guideline. Conclusions: It should be prioritized to explicitly stipulate effective regulations within the Regulation on Occupational Safety and Health Standards. In addition, as regulations on occupational safety and health standards play a large part in preventing industrial accidents, comprehensive and practical measures are indispensable rather than fragmented and formal measures to ensure that these rules function properly in the prevention industrial accidents.

• 한국대기환경학회:학술대회논문집
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• 한국대기환경학회 2003년도 추계학술대회 논문집
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• pp.51-52
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• 2003

A numerical study on PM using a dispersion and deposition model which can analyze for both quantify and quality would not only offer us to understand our environment more easily, but also make it easy that we can make a plan in order to prevent air pollution. The U.S. EPA has proposed the CALPUFF modeling system as a guideline model for regulatory applications involving long-range transport and on a case-by-case basis for near-field applications where. non- steady- state effects which consider situations such as spatial variability in the meteorological fields, calm winds, fumigations, re-circulation or stagnation, and terrain or coastal effects may be important. (omitted)

• 한국철도학회:학술대회논문집
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• 한국철도학회 2008년도 춘계학술대회 논문집
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• pp.1255-1263
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• 2008

A Safety Case is an railway organization's formal arrangement, through the provision of policies, resources and processes, to ensure the safety of its work activity within safety management system. An effective system helps the organization to identify and manage risks effectively. It allows an organization to demonstrate its capability in achieving its safety objectives and in meeting regulatory requirements. The purpose of this research is to give how to the risk assessments are described within Railway Safety Cases can be prepared and maintained to meet the criteria specified by the upcoming railway regulations. Through this research, we propose the elements of safety management system that include arrangements for the ongoing identification of hazards, assessment of risks and the implementation of necessary control measures.

• 한국압력기기공학회 논문집
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• 제20권1호
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• pp.7-15
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• 2024

Environmental qualification is required for safety related electrical equipment under harsh environments located in nuclear power plants according to 10 CFR 50.49 and RG 1.89. As analog technology has recently been replaced by digital technology, NRC established RG 1.209 as a regulatory guideline for environmental qualification of safety related computer-based I&C system located in mild environments, requiring evaluation for electromagnetic compatibility, smoke exposure and type test for actual service conditions such as temperature and humidity. In this paper, the trend of environmental qualification for digital equipment is analyzed by comparing the environmental qualification requirements between digital and analog equipment.

• 디지털융복합연구
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• 제14권3호
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• pp.151-164
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• 2016

본 연구는 개인이 구체적인 목표를 달성해 가는 과정에서 자기효능감이 미치는 영향을 알아보고, 나아가 목표를 달성해 나가는 과정에서 개인이 자아를 통제하는 힘인 자아조절자원이 어떠한 역할을 하는지 알아보고자 하였다. 구체적으로 자기효능감과 목표설정이론 간의 관계를 자아조절자원을 조건으로 구분하여 분석하고자 한다. 이를 위해 대학생들을 대상으로 자아조절자원의 고갈 및 비고갈 집단을 조작하여, 자기효능감과 목표설정에 따른 성과를 측정하였다. 분석 결과, 자기효능감과 성과에 대한 목표설정의 매개효과가 확인되었으며, 자기효능감이 높을수록 자아조절자원이 강화되는 것을 일부 확인하였다. 따라서 자기효능감의 증대는 자아조절자원의 강화를 통해 꾸준히 높은 성과를 올릴 수 있는 토대가 된다는 사실을 확인할 수 있다. 이를 통해 기업에서는 종업원의 장기적인 고성과를 원하는 경우에 참고할만한 가이드라인을 제공할 수 있을 것으로 판단된다.