• Title/Summary/Keyword: regulatory standards

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The Present Status of and Development Plans for Legal Technology in the Fourth Industrial Revolution (4차 산업혁명시대 법정보기술의 현황과 발전방안)

  • Lee, Sung-Jin;Lee, Yeon-Ju;Son, Hyoung-Kun;Kim, Gi-Bum
    • Informatization Policy
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    • v.28 no.1
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    • pp.3-21
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    • 2021
  • Klaus Schwab's discussion on the Fourth Industrial Revolution provides a framework for predicting the direction of legal technology development. Technological convergence, which has emerged as the core concept of the Fourth Industrial Revolution has a significant effect on legal technology. In particular, various new technologies, such as legal chatbots and platforms, are being introduced to enhance efficiency and accessibility in the legal field. However, legal technology is still in its early stage, with institutional improvement needed to vitalize the industry. In this paper, we first specify the concept and classification of legal technology in Chapter 2, followed by trends and limitations in Chapter 3 and ways of vitalizing legal technology in the future in Chapter 4. To invigorate legal technology development, it is necessary to put in place legal regulatory measures that stipulate the active disclosure of legal data, such as precedents, and make free use of such measures. In the law, many issues, such as the safety of artificial intelligence, personal information protection, and ethical standards, will be discussed in the future. Therefore, via this paper, we hope to promote the formation of social consensus and prepare countermeasures, such as legislative measures.

A Study on How to Set up a Standard Framework for AI Ethics and Regulation (AI 윤리와 규제에 관한 표준 프레임워크 설정 방안 연구)

  • Nam, Mun-Hee
    • Journal of the Korea Convergence Society
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    • v.13 no.4
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    • pp.7-15
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    • 2022
  • With the aim of an intelligent world in the age of individual customization through decentralization of information and technology, sharing/opening, and connection, we often see a tendency to cross expectations and concerns in the technological discourse and interest in artificial intelligence more than ever. Recently, it is easy to find claims by futurists that AI singularity will appear before and after 2045. Now, as part of preparations to create a paradigm of coexistence that coexists and prosper with AI in the coming age of artificial intelligence, a standard framework for setting up more correct AI ethics and regulations is required. This is because excluding the risk of omission of setting major guidelines and methods for evaluating reasonable and more reasonable guideline items and evaluation standards are increasingly becoming major research issues. In order to solve these research problems and at the same time to develop continuous experiences and learning effects on AI ethics and regulation setting, we collect guideline data on AI ethics and regulation of international organizations / countries / companies, and research and suggest ways to set up a standard framework (SF: Standard Framework) through a setting research model and text mining exploratory analysis. The results of this study can be contributed as basic prior research data for more advanced AI ethics and regulatory guidelines item setting and evaluation methods in the future.

A Study on the Evaluation of Radiation Safety in Opened-Ceiling-Facilities for Radiography Testing (천장 개방형 RT 사용시설의 방사선 안전성 평가 연구)

  • Sung-Hoe, Heo;Won-Seok, Park;Seung-Uk, Heo;Byung-In, Min
    • Journal of the Korean Society of Radiology
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    • v.16 no.6
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    • pp.741-749
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    • 2022
  • Radiography-Testing that verify the quality of welding structures without destruction are overwhelmingly used in industries, but many safety precautions are required as radiation is used. The workers for Radiography-Testing perform the inspection by moving the Iridium-192 radiation source embedded in the transport container of the gamma-ray irradiator within or outside the facility. The general facility is completely blocked about radiation from the outside with thick concrete, but if it is difficult for worker to handle object of inspection, facilities ceiling can be opened. A general facility may be constructed using a theoretical dose evaluation method because all exterior facilities are blocked, but if the ceiling is open, it is not appropriate to evaluate radiation safety with a simple theoretical calculation method due to the skyshine effect. Therefore, in this study, the radiation safety of the facility was evaluated in the actual field through an ion chamber survey-meter and an accumulated dose-meter called as OSLD, and the actual evaluation environment was modeled and evaluated using the Monte Carlo simulation code as FLUKA. According to the direction of the irradiation, the radiation dose at the facility boundary was difficult to meet the standards set by the regulatory authority, and radiation safety could be secured through additional methods. In addition, it was confirmed that the simulation results using the Iridium-192 source were valid evaluation with the actual measured results.

Estimation of Consumer Value on Import Management of Seafood Obtained from IUU Fishing: Using Choice Experiment Method

  • Ji-Eun An;Se-Hyun Park;Heon-Dong Lee
    • Journal of Korea Trade
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    • v.27 no.2
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    • pp.115-129
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    • 2023
  • Purpose - This study empirically analyzes the consumer value of risk management associated with illegal, unreported, and unregulated (IUU) fishing of fishery products imported to Korea. The global regulatory paradigm for IUU fishing has shifted from production-centered to market-centered. As a result, changes in the international fisheries trade environment emphasizing "transparency" and "legality" of the production process are accelerating. Therefore, changes in the management systems of fishery products entering the country are also needed. Accordingly, this study estimated the consumer value for risk management of IUU fishing, targeting major fish species imported to Korea, and derived the feasibility of introducing related policies. Design/methodology - This study used the choice experiment as an analysis model to estimate consumers' willingness to pay for the "possibility to check for IUU fishing." The choice experiment assumes that the value of a good or service is composed of separable attributes and that the sum of the part-worth of these individual attributes becomes the total value. In this study, respondents were presented with profiles comprising three attributes (country of origin, price, and possibility of checking IUU fishing) and the levels of frozen poulp squid, the subject of the analysis. The participants were asked to select their preferred profile. The marginal willingness to pay for each attribute was derived from the results of the respondents' choices using conditional logit model estimates. Findings - There is a marked difference in utility based on the preference of the country of origin of fishery products among consumers. In addition, the utility of fishery products that have undergone IUU fishing verification was observed to be higher, with the utility marked to be higher for lower prices. Originality/value - Estimating the policy value of the risk management in IUU fishing of imported fisheries products in this study is a novel attempt that has never been conducted before. Several studies have been conducted to assess the risk of IUU fishing associated with the import of fishery products internationally. However, such studies are yet to be conducted in Korea. Instead, policies and studies have focused on issues related to complying with trading partners' legal and transparent standards for exporting fishery products. This study should be the beginning of more in-depth empirical and theoretical explorations to establish order in the domestic seafood market and respond to changes in international regulations on IUU fishing.

Increased Utilization of LTE-Maritime Networks Based on User Requirements (사용자 요구사항 기반 초고속 해상무선통신망 활용성 증대 방안에 대한 연구)

  • Sangjin JANG;Bu-Young KIM;Si-Hwan LEE;Hyo-Jeong KIM;Taehan SONG;Woo-Seong Shim
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.29 no.7
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    • pp.812-818
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    • 2023
  • During the years 2016 to 2020, the Ministry of Oceans and Fisheries embarked on a strategic initiative to develop a comprehensive Korean e-navigation system, which encompassed the establishment of an 'Long Term Evolution for Maritime (LTE-M).' The primary objectives were to proactively align with international navigation standards and enhance maritime safety for small vessels, particularly fishing boats. However, limitations were identified in the utilization of this network, primarily its constrained application for specific purposes. In response to these limitations, this study delves into user-centric investigations through surveys and interviews, with the goal of expanding the horizon of network utilization. User requirements emerged as the result of study, emphasizing the need for broader network applications, a wider range of target users, diverse network utilization methods, and regulatory streamlining. The user-driven insights gleaned from this study hold the potential to inform and shape future legislative measures, fostering more versatile and inclusive LTE-M network utilization for enhanced maritime safety.

NUWARD SMR safety approach and licensing objectives for international deployment

  • D. Francis;S. Beils
    • Nuclear Engineering and Technology
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    • v.56 no.3
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    • pp.1029-1036
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    • 2024
  • Drawing on the deep experience and understanding of the principles of nuclear safety, as well as many years of nuclear power plant design and operation, the EDF led NUWARD SMR Project is developing a design for a Small Modular Reactor (SMR) of 340 MWe composed of two 170 MWe independent units, that will supplement the offering of high-output nuclear reactors, especially in response to specific needs such as replacement of fossil-fuelled power plants. NUWARD SMR is a mix of proven and innovative design features that will make it more commercially competitive, while integrating safety features that comply with the highest international standards. Following the principles of redundancy and diversity and rigorous application of Defence in Depth (DID), with an international view on nuclear safety licensing, the Project also incorporates new safety approaches into its design development. The NUWARD SMR Project has been in development for a number of years, it entered conceptual design formally in mid-2019 and entered Basic Design in 2023. The objective of the concept design phase was to confirm the project technological choices and to define the first design configuration of the NUWARD SMR product, to document it, in order to launch pre-licensing with the French Safety Authority (ASN) and to define its estimated cost and its subsequent development and construction schedules. As a delivery milestone the Safety Options file (called the Dossier d'Options de Sûreté (DOS)) has been submitted to ASN in July 2023 for their opinion. An integral part of the NUWARD SMR Project, is not only to deliver a design suitable for France and to satisfy French regulation, but to develop a product suitable and indeed desirable, for the international market, with a first focus in Europe. In order to achieve its objectives and realise its market potential, the NUWARD SMR Project needs to define and realise its safety approach within an international environment and that is the key subject of this paper. The following paper: • Summarises the foundation principles and technological background which underpin the design; • Contextualises the key design features with regard to the international safety regulatory framework with particular emphasis on innovative passive safety aspects; • Illustrates the Project activities in preparation for first licensing in France, and also a wider international view via the ASN led Joint Early Review of the NUWARD SMR design, including Finnish and Czech Republic regulators, recently joined by the Swedish, Polish and Dutch regulators; • Articulates the collaborative approach to design development from involvement with the Project partners (the Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Naval Group, TechnicAtome, Framatome and Tractebel) to the establishment of the International NUWARD Advisory Board (INAB), to gain greater international insight and advice; • Concludes with the focus on next steps into detailed design development, standardisation of the design and its simplification to enhance its commercial competitiveness in a context of further harmonisation of the nuclear safety and licensing requirements and aspirations.

A Study on the Proposal for Deposit Linkage Plan Based on the Survey of Online Material Identification System (온라인 자료 수집 전략 및 중장기 로드맵 수립 연구)

  • Younghee Noh;Inho Chang;Youngmi Jung;Aekyoung Son;Kyungsun Lee;Hyunju Cha
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.35 no.2
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    • pp.5-23
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    • 2024
  • The seventh year of implementing online material deposit demands a systematic collection, legal and regulatory improvements, and the establishment of a long-term strategic plan for online material collection. In this study, we aimed to propose an online material collection strategy and a long-term roadmap for preserving online resources as national intellectual and cultural heritage for future generations. To achieve this, we analyzed the status of domestic and foreign libraries, related laws and regulations, and the types and collection status of online materials. Based on this analysis, we proposed practical collection standards and methods. Ultimately, a long-term roadmap and implementation plan were suggested. The long-term development plan for online material collection established a phased, concrete implementation strategy. This includes the foundation-building phase of online material collection, followed by the expansion phase, and finally reaching the maturity phase.

Non-clinical Trials using 14C-Acetaminophen to Validate Biomedical Accelerator Mass Spectrometry System (14C-아세트아미노펜 비임상시험을 통한 생체시료 분석용 가속질량분석기의 검증)

  • Jinho Song;Jae Hoon Shim;Jung Bae Park;Chang Su Yeo;Soo Hyeon Bae;Min Sun Choi;Mi Hye Kwon;Kyeong Min Kim
    • Journal of Radiation Industry
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    • v.17 no.2
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    • pp.127-134
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    • 2023
  • Pharmacokinetic (PK) data provide pivotal information in drug development, and they are usually first studied in the preclinical stage using various animals. However, quite often, animal PK data may not match with human PK, especially in metabolites. Thus, most regulatory agencies in the world make it mandatory to obtain metabolite information using 14C radiolabeled drug in human for small molecule drug candidates. However, such studies are expensive and time consuming and they are usually done at the end of Phase II trials using ~3.7 MBq of 14C labeled drug in a limited number of human subjects. Introduction of accelerator mass spectrometry (AMS) in this kind of study has revolutionized it. Since AMS can measure 14C level as close as natural abundance, it can quantify the amounts of 14C labeled drugs and their metabolites produced in human body that consumes less than the amount of 0.0037 MBq of 14C labeled drug, a very safe level of radioactive dose in human. Therefore, it is now possible to conduct human 14C studies safely in early clinical trials without spending hefty amount of money and time. Korea Radioisotope Center for Pharmaceuticals(KRICP) at Korea Institute of Biological and Medical Sciences(KIRAMS) has established an AMS facility in 2018, housing a 0.5MV AMS manufactured at the US National Electrostatics Corps (NEC). The AMS instrument has been validated using various standard samples that have been prepared at Lawrence Livermore National Laboratory in the US, a worldly reputable provider of AMS standards. In this paper, we present a mass balance study for acetaminophen in rats using AMS and prove that the study results are equivalent with those of literature, which shows the AMS facilities at KRICP has successfully installed and be ready to be used in the various PK studies using 14C labelled compounds for new drug development.

A Study on Aviation Safety and Third Country Operator of EU Regulation in light of the Convention on international Civil Aviation (시카고협약체계에서의 EU의 항공법규체계 연구 - TCO 규정을 중심으로 -)

  • Lee, Koo-Hee
    • The Korean Journal of Air & Space Law and Policy
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    • v.29 no.1
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    • pp.67-95
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    • 2014
  • Some Contracting States of the Chicago Convention issue FAOC(Foreign Air Operator Certificate) and conduct various safety assessments for the safety of the foreign operators which operate to their state. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident. FAOC also burdens the other contracting States to the Chicago Convention due to additional requirements and late permission. EASA(European Aviation Safety Agency) is a body governed by European Basic Regulation. EASA was set up in 2003 and conduct specific regulatory and executive tasks in the field of civil aviation safety and environmental protection. EASA's mission is to promote the highest common standards of safety and environmental protection in civil aviation. The task of the EASA has been expanded from airworthiness to air operations and currently includes the rulemaking and standardization of airworthiness, air crew, air operations, TCO, ATM/ANS safety oversight, aerodromes, etc. According to Implementing Rule, Commission Regulation(EU) No 452/2014, EASA has the mandate to issue safety authorizations to commercial air carriers from outside the EU as from 26 May 2014. Third country operators (TCO) flying to any of the 28 EU Member States and/or to 4 EFTA States (Iceland, Norway, Liechtenstein, Switzerland) must apply to EASA for a so called TCO authorization. EASA will only take over the safety-related part of foreign operator assessment. Operating permits will continue to be issued by the national authorities. A 30-month transition period ensures smooth implementation without interrupting international air operations of foreign air carriers to the EU/EASA. Operators who are currently flying to Europe can continue to do so, but must submit an application for a TCO authorization before 26 November 2014. After the transition period, which lasts until 26 November 2016, a valid TCO authorization will be a mandatory prerequisite, in the absence of which an operating permit cannot be issued by a Member State. The European TCO authorization regime does not differentiate between scheduled and non-scheduled commercial air transport operations in principle. All TCO with commercial air transport need to apply for a TCO authorization. Operators with a potential need of operating to the EU at some time in the near future are advised to apply for a TCO authorization in due course, even when the date of operations is unknown. For all the issue mentioned above, I have studied the function of EASA and EU Regulation including TCO Implementing Rule newly introduced, and suggested some proposals. I hope that this paper is 1) to help preparation of TCO authorization, 2) to help understanding about the international issue, 3) to help the improvement of korean aviation regulations and government organizations, 4) to help compliance with international standards and to contribute to the promotion of aviation safety, in addition.

Optimization of Analytical Methods for Octacosanol in Related Health-functional Foods with GC-MS (GC-MS를 이용한 건강기능식품 중 옥타코사놀 분석법 개발 연구)

  • Lee, Jin Hee;Oh, Mi Hyune;Lee, Kyung Jin;Kim, Yang Sun;Keum, Eun Hee;Park, Ji Eun;Cho, Mee Hyun;Seong, Min Hye;Kim, Sang A;Kim, Mee hye
    • Journal of Food Hygiene and Safety
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    • v.33 no.4
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    • pp.266-271
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    • 2018
  • The Ministry of Food and Drug Safety (MFDS) is amending its test methods for health-functional foods (dietary food supplements) to establish regulatory standards and specifications in Korea. In this regard, we continue our research on developing analytical methods for the items. Octacosanol is the major component of polycosanol and is a high-molecular-mass primary fatty alcohol, obtained from sugar cane wax. Previous researchers have shown that octacosanol can lower cholesterol and has antiaggregatory properties, cytoprotective uses, and ergogenic properties for human health. Recently, octacosanol products have been actively introduced into the domestic market because of their functional biological activity. We have developed a sensitive and selective test method for octacosanol that the TMS derivatives by means of gas-chromatographic-tandem mass spectrometry (GC-MS). The trimethylsilyl ether derivative of the target analyte showed excellent chromatographic properties. The procedure was validated in the range of $12.5{\sim}200{\mu}g/L$. Standard calibration curves presented linearity with the correlation coefficient ($r^2$) > 0.999, and the limits of detection (LOD) and limits of quantitation (LOQ) were $4.5{\mu}g/L$ and $13.8{\mu}g/L$, respectively. The high recoveries (92.5 to 108.8%) and precision (1.8 to 2.4%) obtained are in accordance with the established validation criteria. Our research can provide scientific evidence to amend the octacosanol test method for the Health-Functional Food Code.