• 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.

• 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.

• 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.

• 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.

• 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.

• Asia-Pacific Journal of Business Venturing and Entrepreneurship
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• v.7 no.2
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• pp.113-127
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• 2012

From the end of 1st quarter of 2012, Korean mandatory firms had started releasing financial reports conforming to the K-IFRS(Korean adopted International Financial Reporting Standards). Major characteristics of IFRS, such as 'principles based' features, consolidated reporting, 'fair value' measurement, increased pressure for non-financial disclosures have resulted in brief and various disclosure practices regarding the main body of each statements and vast amount of note description requirements. Meanwhile, a host of previous studies on IFRS disclosures have incorporated regulatory and/or 'compete information' perspectives, mainly focusing on suggesting further enforcement of strengthened requirements and providing guidelines for specific treatments. Thus, as an extension of prior findings and suggestions this study had explored to conduct an integrative approach embracing views of the reporting entities and the users of financial information. In spite of all the state-driven efforts for faithful representation and comparability of corporate financial reports, an overhaul of disclosure practices of fiscal year 2010 and 2011 had revealed numerous cases of insufficiency and discordance in terms of mandatory norms and market expectations. As to the causes of such shortcomings, this study identified several factors from the corporate side and the users of the information; some inherent aspects of IFRS, industry/corporate-specific context, expenditures related to internalizing IFRS system, reduced time frame for presentation. lack of clarity and details to meet the quality of information - understandability, comparability etc. - commonly requested by the user group. In order to improve current disclosure practices, dual approach had been suggested; Firstly, to encourage and facilitate implementation, (1) further segmentation and differentiation of mandates among companies, (2) redefining the scope and depth of note descriptions, (3) diversification and coordination of reporting periods, (4) providing support for equipping disclosure systems and granting incentives for best practices had been discussed. Secondly, as for the hard measures, (5) regularizing active involvement of corporate and user group delegations in the establishment and amendment process of K-IFRS (6) enforcing detailed and standardized disclosure on reporting entities had been recommended.

• Journal of Food Hygiene and Safety
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• v.33 no.2
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• pp.124-130
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• 2018

The Ministry of Food and Drug Safety (MFDS) is amending its test methods for the use of health functional foods (dietary food supplement), in order to establish regulatory standards and specifications in Korea. In this regard, we continue to pursue and perform our research on the analytical method development for the items being researched and reviewed. In this study, we have developed a sensitive and selective test method that could simultaneously separate and determinate six major bioactive flavonolignans in silymarin, which are based on the use of a liquid chromatographic-tandem mass spectrometry (LC-MS/MS). The standard calibration curves presented a linearity effect with the correlation coefficient ($r^2$) > 0.999. The limits of detection (LODs) and limits of quantitation (LOQs) were in the range of $0.3{\sim}9.0{\mu}g/L$ and $0.8{\sim}27.3{\mu}g/L$, respectively. The recovery results ranged between 96.2~98.6% at 3 different concentration levels, and its relative standard deviations (RSDs) were less than 5% as noted in this study. The proposed analytical method was characterized with a noted high resolution of the individual silymarin constituents, and the assay was fully validated as well. Our research can provide a significant scientific evidence that can be useful to amend the silymarin test method for the Health Functional Food Code.

• The Korean Journal of Air & Space Law and Policy
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• v.33 no.2
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• pp.291-314
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• 2018

In recent 3 years, Korea's low-cost airlines have expanded their areas of passenger transportation not only to domestic market but also to Japan, China, Southeast Asia and US territory as a total of 6 companies (8 airlines including small air operation business carriers). Currently, three more airlines have filed for air transportation business certification as future low-cost carriers, and this expansion is expected to continue. To cope with the aggressive airline operations of domestic and foreign low-cost carriers and to enhance their competitiveness, each low-cost airline is taking a number of strategies for promoting cabin service. Therefore, the workload of the cabin crew is increased in proportion to the expansion, and the fatigue directly connected with the safety task performance is increased. It is stipulated in the Enforcement Regulations of the Korea Aviation Safety Act that at minimum, one cabin crew is required per 50 passenger seating capacity, and all low cost carriers are boarding only the minimum cabin crew. Sometimes it is impossible for them to sit in a floor level emergency exit for evacuation, which is the main task of the cabin crew, and this can cause confusion among evacuating passengers in the event of an emergency. In addition, if one of the minimum cabin crew becomes incapacitated due to an injury or the like, it will become a serious impediment in performing emergency evacuation duties. Even in the normal situation, since it will be violating the Act prescription on the minimum cabin crew complement, passengers will have to move to another available airline flights, encountering extreme inconvenience. Annex 6 to the Convention on International Civil Aviation specifies international standards for the determination of the minimum number of cabin crew shall be based only on the number of passenger seats or passengers on board for safe and expeditious emergency evacuation. Thereby in order to enhance the safety of the passengers and the crew on board, it is necessary to consider the cabin crew's fatigue that may occur in the various job characteristics (service, safety, security, first aid)and floor level emergency exit seating in calculating the minimum number of cabin crew. And it is also deemed necessary for the government's regulatory body to enhance the cabin safety for passengers and crew when determining the number of minimum cabin crew by reflecting the cabin crew's workload leading to their fatigue and unavailability to be seated in a floor level emergency exit on low cost carriers.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.117-157
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• 2021

This research reviewed the HIPAA/HITECH, 21st Century Cures Act, Common Law, and private Guidances from the perspectives in protecting and utilitizing the medical data, while implications were followed. First, the standards for protection and utilization are relatively clearly regulated through single law on personal medical information in the United States. The HIPAA has been introduced in 1996 as fundamental act on protection of medical data. Medical data was divided into personally identifiable information, non-identifying information, and limited dataset under HIPAA. Regulations on de-identification measures for medical information, objects for deletion of limited data sets, and agreement on prohibition of data re-identification were stipulated. Moreover, in the 21st Century Cures Act regulated mutual compatibility for data sharing, prohibition of data blocking, and strengthening of accessibility of data subjects. Common Law introduced comprehensive consent system and clearly stipulates procedures. Second, the regulatory system is relatively simplified and clearly stipulated in the United States. To be specific, the expert consensus and the safe harbor system were introduced as an anonymity measure for identifiable medical information, which clearly defines the process while increasing trust. Third, the protection of the rights of the data subject is specified, the duty of explanation is specified in detail, while the information right of the consumer (opt-out procedure) for identification information is specified. For instance, the HHS rule and FDA regulations recognize the comprehensive consent system for human research, but the consent procedure, method, and requirements are stipulated through the common rule. Fourth, in the case of the United States, a trust-based system is being used throughout the health and medical data legislation. To be specific, Limited Data Sets are allowed to use in condition to the researcher's agreement to prohibit re-identification, and de-identification or consent process is simplified under the system.

• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.881-887
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• 2023

This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.