• Title/Summary/Keyword: 규제개선

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A Liability for Damage caused by Drug (의약품 부작용과 손해배상)

  • Song, Jinsung
    • The Korean Society of Law and Medicine
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    • v.21 no.3
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    • pp.77-116
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    • 2020
  • The use of drugs that reflect the experiences and achievements of modern science has given human being the benefits of treating diseases and improving health conditions. However, in addition to the benefits of those, medicines have inherently inevitable adverse reactions. Many countries are taking measures such as market entry regulations or post-marketing surveillance to minimize damage caused by drug side effects, but the occurrence of side effects cannot be eliminated. Although the damage is force majeure, in some cases, the doctor who prescribed the drug or the pharmacist who administered the drug may have to compensate for the damage. The liability depends on whether the side effects were known in advance, the type of medicine, etc. On the other hand, in some cases, drug manufacturer may have to take liability for the side effect itself. As it is not easy for victims to be compensated for damages in those cases, many countries, including Korea, are setting to protect victims through the Product Liability Act. Drugs are also one of the product, so liability set by the Product Liability Act may apply. Even before the enactment and enforcement of the Product Liability Act, damage caused by drug has occurred. To resolve them, precedents have developed case law, which have many similarities with the Product Liability Act, but also have differences. Damage caused by drug manufactured prior to the enforcement of the Product Liability Act may occur in the future. In this context, the legal principles of the case laws will remain valid and be applied. This is an important reason to review the case law of precedents.

A Study on the Effectiveness of Risk Assessment for School Food Service Workers (학교 급식종사자를 대상으로 한 위험성평가의 실효성에 관한 연구)

  • Cho, Guy-Sun;Yi, Dae-Ho;Jun, Jin-Woo
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.22 no.4
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    • pp.90-98
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    • 2021
  • Since 2017, the Occupational Safety and Health Act has been fully applied to school food services, and risk assessments have been implemented since 2019. The introduction was slow compared to other industries and was evaluated by non-professional nutritionists, so there was a limit to establishing the system. All schools under the Seoul Metropolitan Office of Education apply the KRAS every year in accordance with the OSH Act for school foodservice and a notice from the Ministry of Employment and Labor. A risk assessment is applied according to legal regulations. On the other hand, the effectiveness of risk assessment has been questioned because the frequency and intensity criteria of the risk are qualitative and subjective. Based on the accident statistics of catering workers, the frequency and intensity criteria of risk were presented quantitatively and objectively, and a risk assessment was conducted by applying a new calculation standard for some work during the catering service and compared with current risk assessment results. The risk was increased, and the improved effectiveness was confirmed by the specific suggestions for improvement. Thus, the pilot evaluation for the entire food service should be expanded, and the feasibility confirmed. The pilot evaluation should be applied to all schools to enhance the effectiveness and operability of the risk assessment.

The in-use stability study of multi-use ophthalmic solutions -Focused on Olopatadine, Fluorometholone, Dorzolamide, Timolol- (다회용 점안제의 개봉 후 안정성 평가 -올로파타딘, 플루오로메톨론, 도르졸라미드, 티몰롤 약물 중심-)

  • Shin, Seo-young;Jang, Kyoung won;Sun, Sangouk;Ha, Dongmun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.2
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    • pp.681-693
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    • 2019
  • Multi-use ophthalmic solutions are used many times after opening; therefore, there is a high possibility of decreased quality during use. This study was conducted to determine the recommended use period of multi-use ophthalmic solutions based on evaluation of the stability by comparing stability evaluation regulations of the USA, EU and Korea We selected four types of multi-use ophthalmic solutions (Olopatadine (Olo), Fluorometholone (Flu), Dorzolamide (Dor), Timolol (Timol)) that are frequently marketed in Korea and evaluated their stability during storage according to the actual usage method after opening. The Olo had a decrease in assay and preservative content at 2 months after opening, while Flu showed a significant difference from day 28 after opening. For Dor, significant differences were observed from day 14 after opening in the assay and impurity test item and Timol showed a significant difference from day 28 after opening. Based on the results of the stability test Olo and Flu should only be used within 28 days of opening, while Dor and Timol should be used within 14 days of opening. Therefore, we suggest that regulations system related use periods of multi-use ophthalmic solutions designed as aseptic preparations should be improved based on the results of stability tests after opening.

Status and prospect of safety evaluation of genetically modified microorganism (GMM) for domestic and foreign food application (국내·외 식품용 유전자변형미생물 안전성 심사 현황 및 전망)

  • Kim, Seong-Bo;Kim, Yang Hee
    • Food Science and Industry
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    • v.52 no.2
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    • pp.153-170
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    • 2019
  • With the breathtaking stride beingmade in the field of biotechnology, biocatalyst research using genetically modified microorganism (GMM) is actively being pursued in food industry. However, domestic food and food additive regulation standards and the number of examination management examples currently used in industry is lacking significantly. Up till now, there are only 6 examples of domestic GMM examination and approval cases for food production purposes and furthermore they are limited to the production of functional sweeteners. Domestically, although GMM is developed as a processing aid (contained use), if they are used in the production of food, the safety of GMM, including environmental safety, is evaluated. Also the produced food or food additives using GMM need to be separately examined and approved as a novel food. On the other hand, imported products produced using GMM need to gain approval for the final product only. Thus the expense and the time to obtain regulatory approval is advantageous for imported products versus domestically produced products. This commentary is written to create the opportunity to reform the current domestic food GMM regulation by comparing and discussing domestic and foreign case analyses of safety evaluation of GMM and related regulations.

Secure Training Support Vector Machine with Partial Sensitive Part

  • Park, Saerom
    • Journal of the Korea Society of Computer and Information
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    • v.26 no.4
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    • pp.1-9
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    • 2021
  • In this paper, we propose a training algorithm of support vector machine (SVM) with a sensitive variable. Although machine learning models enable automatic decision making in the real world applications, regulations prohibit sensitive information from being used to protect privacy. In particular, the privacy protection of the legally protected attributes such as race, gender, and disability is compulsory. We present an efficient least square SVM (LSSVM) training algorithm using a fully homomorphic encryption (FHE) to protect a partial sensitive attribute. Our framework posits that data owner has both non-sensitive attributes and a sensitive attribute while machine learning service provider (MLSP) can get non-sensitive attributes and an encrypted sensitive attribute. As a result, data owner can obtain the encrypted model parameters without exposing their sensitive information to MLSP. In the inference phase, both non-sensitive attributes and a sensitive attribute are encrypted, and all computations should be conducted on encrypted domain. Through the experiments on real data, we identify that our proposed method enables to implement privacy-preserving sensitive LSSVM with FHE that has comparable performance with the original LSSVM algorithm. In addition, we demonstrate that the efficient sensitive LSSVM with FHE significantly improves the computational cost with a small degradation of performance.

Improving the Port-Reception-Facility System (선박 배출 오염물질 항만처리시스템 확보방안 연구)

  • Ha, Shin-Young;Gug, Seung-Gi
    • Journal of Navigation and Port Research
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    • v.44 no.6
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    • pp.488-493
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    • 2020
  • In this study, we sought to establish a vessel-discharge pollutant-treatment system recommended by IMO by first investigating advanced facilities overseas to help us understand and evaluate our domestic facility and needs. IMO recommends the installation and operation of port pollutant-storage facilities to adequately treat pollutants emitted by ships entering the port, and we reviewed the registration and operation of these facilities in IMO member countries, focusing on the IIII Code. Due to recent environmental regulations, additional facilities are required to treat the washing water discharged from equipment such as scrubbers mounted on the ship so pollutant-storage facilities must be established. Currently, Korea's ship-discharged wastes are being moved from ports to land waste-treatment plants, and their quantity and properties are not being monitored. Therefore, in this study, we improved monitoring of the discharged pollutants and investigated the proper arrangement of pollutant storage facilities as recommended by IMO. The system we established can help provide smooth service to incoming ships - and appropriate treatment of pollutants and will greatly benefit international maritime operations.

An Analysis of Movements in the Labor Share of Income in the Korean Manufacturing Industries (한국 제조업에서의 노동소득분배율 변동요인 분석)

  • Hong, Jang-Pyo
    • Korean Journal of Labor Studies
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    • v.19 no.1
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    • pp.1-34
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    • 2013
  • Labor share of income in Korea has fallen from 90% in 1996 to 79% in 2010. This paper explores the factors driving the movements in the labor share of income based on a panel dataset containing 19 years of data on 18 Korean manufacturing industries. The effects of technical progress, globalization and the bargaining power of labor and capital on the labor share of income are tested for the period of 1991-2009. The main empirical results are as follows. (1) Capital-aug menting technical prog ress measured by capital-labor ratio and R&D intensity has a negative effect on the labor share. (2) Market openness measured by the value of export and import as a ratio to value-added production is found to have a positive impact. (3) Globalization of production measured by inward-FDI and outward-FDI as a ratio to total domestic fixed capital is found to have a negative impact on the labor share. (4) Union density is found to have had a statistically significant effect in 1991-1998. This finding is consistent with the efficient bargain model in which firms and workers bargain over both wages and employment. But union density is insignificant in 2000-2009. This implies that since the financial crisis in 1997, the bargaining institution in Korea has been approaching the right-to-manage model in which firms and unions bargain over wages and then firms set employment unilaterally. (5) Variables for domestic financialization measured by dividend-income ratio and financial-fixed assets ratio have an insignificant effect on labor share.

A Study on Structural Analysis for Improving Driving Performance of Agricultural Electric Car (농업용 전기운반차의 주행성능 향상을 위한 구조해석에 관한 연구)

  • Jo, Jae-Hyun;Lee, Sang-Sik
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.13 no.6
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    • pp.556-561
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    • 2020
  • The aging and declining agricultural population in the modern society requires improvement of the agricultural environment and is one of the representative problems. And since most of the work systems always require a transport work, the ratio of labor consumed in the transport work is very high. Accordingly, many types of transport vehicles are being developed and sold, and in the early days, most of them are powered transport vehicles using fossil fuels. However, it is paying attention to next-generation eco-friendly energy such as hydrogen, fuel cells, solar power, and bio due to the strengthening of international environmental regulations such as global warming and the Convention on Climate Change and the depletion of fossil fuels. Therefore, in this study, the ultimate goal is to develop an eco-friendly, easy-to-operate, safe agricultural electric vehicle that replaces fossil fuels. It was designed with a focus on controlling a wide range of vehicle speeds and securing stability of electric agricultural vehicles. Considering the performance and design, it is composed of a frame, a driving part, a steering part, and a controller system, and we are going to review and manufacture each part. It is believed that the manufactured electric vehicle for agriculture can be easily and conveniently operated in an agricultural society where young manpower is scarce, and can be helpful to the agricultural society through high efficiency.

Characteristics of Non-nano Needle Type Zinc Oxide and Its Application in Sunscreen Cosmetics (Non-nano 막대형 산화아연의 특성 및 자외선 차단용 화장품에의 응용)

  • Chong, Kyo Un;Xuan, Song Hua;Yoon, Yeo Min;Kim, Sang-uk;Choi, Bou Kun;Lee, Sung Ho;Park, Soo Nam;Lee, Jong Sung
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.47 no.1
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    • pp.1-7
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    • 2021
  • With increasing interest in the effectiveness and safety of sunscreen worldwide, research on the development of new inorganic sunscreen is also gaining momentum. In the present study, non-nano sized needle type zinc oxide, which can meet the regulation of nano-material as a recent problem, has been synthesized and surface-modified with cetyl alcohol to obtain needle type zinc oxide powder. Here, we also investigated their physical properties and evaluated their potential application as sunscreens. As a result of the experiment, the sunscreen with needle type zinc oxide powder, which was non-nano, showed similar UV-protection properties and transparency compare to that of 40nm size zinc oxide. It was further confirmed that the UV blocking effect was significantly increased when the needle type zinc oxide dispersion was applied to the sunscreen. Therefore, although the needle type zinc oxide is non-nano (200 nm) material, it has the potential to be applied to the product as an excellent transparency (improvement of whiteness), UV protection efficacy and smooth texture.

Analysis of Changes in Power Generation of Each Power Generation Company by the Fine-Dust Seasonal Management System (미세먼지 계절관리제로 인한 발전사별 전력생산량 변화 분석)

  • Kim, Bu-Kwon;Won, Doo Hwan
    • Environmental and Resource Economics Review
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    • v.30 no.4
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    • pp.627-648
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    • 2021
  • The fine-dust season management system refers to the policy of implementing enhanced reduction measures in transportation, power, business and living sectors in winter, when fine dust levels are high. The fine dust season management system is a regulatory policy that causes social costs and transfers to various economic players. Equity is an important issue for the cost burden. Therefore, in this study, the cost of each power generator was analyzed using the coal power generation reduction amount of each power generator to verify that the cost of the power sector is evenly distributed. In particular, the effect of the fine dust season management system on coal power generation of power generators was analyzed by applying a synthetic control method that can identify the time-variable effect of the policy. It was confirmed that the fine dust season management system reduced volume of fuel and power generation in coal power plants, resulting in an increase in the cost of the power generation sector, even considering the effect of some power demand due to the COVID-19 crisis. However, it could be seen that these costs were not distributed equally among the generators, and that they were more costly to the specific generators.Social costs incurred by fine dust season management need to be improved so that stakeholders are equally burdened.