• Journal of Aerospace System Engineering
• /
• v.14 no.3
• /
• pp.32-41
• /
• 2020

The International Civil Aviation Organization (ICAO) in 2015 proposed a road-map for the global recognition system of the Approved Maintenance Organization (AMO) fto mitigate the redundant work and regulatory burdens of the aviation industry and authorities on the certification and oversight activities of the State of Registry. Since then, the ICAO standards and guidelines have been revised accordingly with the goal of implementing the system in 2024. Korea should actively prepare for this AMO global recognition system to cope with the ICAO road-map appropriately as well as to develop the Maintenance Repair Overhaul (MRO) industry. Thus, this paper focused on the ratings and limitations system, a key element of the AMO, and proposes the improvement of domestic regulatory/administrative rules necessary for the global recognition system, through the review of newly established ICAO standards/guidelines and the comparative analysis of leading aviation countries' and Korean system/requirements.

• Journal of the Korean Institute of Landscape Architecture
• /
• v.39 no.2
• /
• pp.18-28
• /
• 2011

This study is aimed at the improvement of administrative operations of landscape design competitions and qualitative enhancement of design quality by mutually comparing the guidelines and entry plans. The case targeted for the current study is landscape design proposals for the Seoul Hangdong Bogeumjari Housing District recently launched within a greenbelt zone in the outskirts of Seoul. The study examines from a critical perspective the design guidelines and the contents of the three winning design proposals with a focus on whether or not they have reflected the guidelines. It was observed that many provisions of the principles and conceptual guidelines which serve as clues to the designs for winning designs proposals show the direction in which the project is to be headed It was also observed that the provisions and the way they are expressed are intertwined, while, at the same time, the guidelines were not organized or developed in an orderly manner. Such a structural pattern of the guidelines is linked to the aspects of the contents of the winning design proposals as described in the following. It is observed that guidelines related to the direction in which the design to be headed are so regulatory and lengthy that they are overly standardized. This could make it difficult to read the possibility of the alternative shifts in the winning design proposals. At the same time, the attributes of winning design proposals themselves, which require observable discriminatory superiority, could serve as a factor causing excess of meanings by jumping on the bandwagon of naming. On the contrary, where autonomy of design is guaranteed or no guidelines are provided for the winning design proposals, discriminatory differences were observed, thereby making it easy to measure them This illustrates well that guidelines and structural format should be provided through a separate undertaking that has taken into careful consideration environmental traits of the site in question, objectives required and so forth.

• Proceedings of the Korean Society of Toxicology Conference
• /
• 2006.11a
• /
• pp.80-86
• /
• 2006

Bioequivalence is a term in pharmacokinetics used to access the expected in vivo biological equivalence of two proprietary preparations of a drug. Bioequivalence studies are usually performed for generic drugs. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilioes after administration in the same molar dose are similar. Bioequivalence is usually accessed by single dose in vivo studies in healthy volunteers and the reference product is usually the innovator product that is marketed. Regulatory definition of bioequivalence is based on the statistical analysis of thebioavailability of the reference and test product. In general, two products are evaluated as bioequivalent if the 90% confidence interval of the relative mean Cmaxand AUC of the test to reference product are within 80.00% to 125.00% in the fasting state. Key process in bioequivalence study is development and validation of bioanalytical method, determination of the drug concentration in the biosamples (usually plasma or serum) obtained from volunteers, calculation of the pharmacokinetic parameters and statistical analysis of the pharmacokinetic parameters. Although current guidelines and regulations do not require the bioequivalence studies to be done under good laboratory practice (CLP), the issues to perform the bioequivalence studies under GLP environment is emerged both from the regulatory and industry side. GLP perspectives of bioequivalence studiesare needed to be discussed in respect to achieve quality assurance in bioequivalence studies.

• Journal of Information Science Theory and Practice
• /
• v.4 no.3
• /
• pp.6-27
• /
• 2016

There has been a growing interest and enthusiasm for the application of virtual worlds in learning and training. This research proposes a design framework of a virtual world-based learning environment that integrates two unique features of the virtual world technology, immersion and interactivity, with an instructional strategy that promotes self-regulatory learning. We demonstrate the usefulness and assess the effectiveness of our design in the context of information security learning. In particular, the information security learning module implemented in Second Life was incorporated into an Introduction to Information Security course. Data from pre- and post- learning surveys were used to evaluate the effectiveness of the learning module. Overall, the results strongly suggest that the virtual world-based learning environment enhances information security learning, thus supporting the effectiveness of the proposed design framework. Additional results suggest that learner traits have an important influence on learning outcomes through perceived enjoyment. The study offers useful design and implementation guidelines for organizations and universities to develop a virtual world-based learning environment. It also represents an initial step towards the design and explanation theories of virtual world-based learning environments.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
• /
• v.19 no.3
• /
• pp.367-386
• /
• 2021

The overestimation and underestimation of the radioactivity concentration of difficult-to-measure radionuclides can occur during the implementation of the scaling factor (SF) method because of the uncertainties associated with sampling, radiochemical analysis, and application of SFs. Strict regulations ensure that the SF method as an indirect method does not underestimate the radioactivity of nuclear wastes; however, there are no clear regulatory guidelines regarding the overestimation. This has been leading to the misuse of the SF methodology by stakeholders such as waste disposal licensees and regulatory bodies. Previous studies have reported instances of overestimation in statistical implementation of the SF methodology. The analysis of the two most popular linear models of the SF methodology showed that severe overestimation may occur and radioactivity concentration data must be dealt with care. Since one major source of overestimation is the use of minimum detectable activity (MDA) values as true activity values, a comparative study of instrumental techniques that could reduce the MDAs was also conducted. Thermal ionization mass spectrometry was recommended as a suitable candidate for the trace level analysis of long-lived beta-emitters such as iodine-129. Additionally, the current status of the United States and Korea was reviewed from the perspective of overestimation.

• Nuclear Engineering and Technology
• /
• v.54 no.11
• /
• pp.3975-3984
• /
• 2022

Distributed control system architecture is adopted for I&C systems of Prototype Fast Breeder Reactor, where the geographically distributed control systems are connected to centralized servers & display stations via switched Ethernet networks. TCP/IP communication plays a significant role in the successful operations of this architecture. The communication tasks at control nodes are taken care by TCP/IP offload modules; local area switched network is realized using layer-2/3 switches, which are finally connected to network interfaces of centralized servers & display stations. Safety, security, reliability, and fault tolerance of control systems used for safety-related applications of nuclear power plants is ensured by indigenous design and qualification as per guidelines laid down by regulatory authorities. In the case of commercially available components, appropriate suitability analysis is required for getting the operation clearances from regulatory authorities. This paper details the proposed approach for the suitability analysis of TCP/IP communication nodes, including control systems at the field, network switches, and servers/display stations. Development of test platform using commercially available tools and diagnostics software engineered for control nodes/display stations are described. Each TCP link behavior with impaired packets and multiple traffic loads is described, followed by benchmarking of the network switch's routing characteristics and security features.

• Food Science of Animal Resources
• /
• v.43 no.6
• /
• pp.1002-1016
• /
• 2023

This study aimed to develop appropriate temperature management practices and provide scientific evidence to support the development of sell-by-date guidance for eggs. Washed and unwashed eggs were subjected to storage under six different scenarios, and both types of eggs were stored at temperatures up to 35℃ to evaluate the sell-by-date. Despite temperature fluctuations or continuous storage at 30℃ for 5 days, subsequent storage at 10℃ resulted in significantly higher Haugh unit and yolk index on day 15. These results indicate that refrigerating eggs from retail sales until consumption is effective for egg quality management, despite the exposure of up to 35℃ during distribution. In terms of sell-by-date evaluation, washed eggs retained class B quality for an additional 37 days beyond the recommended sell-by-date at 15℃, which is above the regulated storage temperature. However, unwashed eggs maintained class B quality for approximately 20 days at 30℃-35℃, emphasizing the need for sell-by-date guidelines for unwashed eggs. This study is the first to provide appropriate egg-handling practices based on the actual distribution environment in Korea.

• Environmental Analysis Health and Toxicology
• /
• v.31
• /
• pp.26.1-26.9
• /
• 2016

Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

• Korean Journal of Clinical Pharmacy
• /
• v.31 no.1
• /
• pp.53-60
• /
• 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.

• Knowledge Management Research
• /
• v.24 no.3
• /
• pp.73-94
• /
• 2023

With the virtual asset market's rapid growth, government regulations on listing and trading procedures are expected. However, specific measures are currently lacking. To ensure stable inclusion in the institutional framework, precise regulations are needed for market development and investor protection. This study compares self-regulatory guidelines of the top domestic virtual asset exchanges with Korea Exchange's Preliminary Listing Examination Standards (2022) to enhance timeliness and relevance. It defines IEO, IPO, and ICO concepts and addresses conflicts of interest in IEO. Analyzing delisted virtual assets, it categorizes issues and classifies listing examination guidelines into formal and qualitative requirements. The study examines self-regulatory guidelines based on continuity, transparency, stability, corporate characteristics, and investor protection criteria, along with five special requirements for virtual assets. Improvement measures include regular disclosures of governance structure, circulation volume, and the establishment of independent audit institutions. This research further analyzes delisting cases, classifies issues, and proposes solutions. Considering stock market similarities, it offers measures based on the institutional framework.