• Title/Summary/Keyword: 심사정

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Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices (의료기기 일괄허가 및 기술문서 심사를 위한 품목별 길라잡이 개발)

  • Kim, Yong-Woo;Shin, Chae-Min;Bang, Ji-Young;Yi, Jung-Yeon;Oh, Hyeon-Joo;Bae, Woo-Jin;Choi, Jin-Man;Lim, Kyung-Mi;Oh, Heon-Jin;Kim, Mi-Young;Hur, Chan-Hoi;Kim, Hyung-Bum;Choi, Min-Yong;Kwak, Ji-Young;Kim, Su-Yeon;Hwang, Sang-Yeon;Youn, Hae-Suk;Hong, Hye-Kyeong;Ahn, So-Young;Lee, Chang-Hyung;Jeong, Jin-Baek;Koo, Ja-Jung;Kang, Se-Gu;Jung, Jae-Hoon;Lim, Kyoung-Taek;Lim, Chang-Keun;Kim, Min-Su;Lee, Seong-Hyi;Lee, Jae-Keun;Park, Ki-Jung
    • Journal of Biomedical Engineering Research
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    • v.31 no.4
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    • pp.280-284
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    • 2010
  • Approvals of medical device increase every year as industry of medical device grows. Therefore KFDA keeps trying to improve approval systems. However, the firms of medical device are in trouble due to regulation amendment, a firm of small size, exchange of the person in charge. The staffs of KFDA increase their work load because applicants of approval of medical device aren't used to writing of document. Therefore the firm of medical device in business have a long term. KFDA develops eight guidance document item by item for one-step evaluation and approval for Medical Devices because applicants of approval of medical device write documents easily. KFDA reviewer can carry on quick reviewing in use of this eight guidances. This guidance are improved on satisfaction of applicants of approval of medical device.

Administrative Legislation Procedures, Pre-Notices, Listening to Opinions under the Administrative Law of the United States - Focusing on the Analysis of the 2019 Ruling, Federal Supreme Court Azar v. Allina Health Service, 587 U.S. 1804 - (미국 행정법상 행정입법절차와 사전통지, 의견청취 - Azar v. Allina Health Service, 587 U.S. 1804 2019 판결에 대한 분석을 중심으로 -)

  • Kim, Yong-Min
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.187-220
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    • 2020
  • Today, administrative legislation is becoming more and more important in that it not only sets the legal life relationship of the people in great detail and detail, but is closely related to the occurrence, extinction, and alteration of rights and obligations held by prisoners. In the United States, the types of administrative legislation are divided into substantive and interpretative regulations, so-called substantive regulations, which give prior notice and opportunity to comment on interested parties through formal or informal administrative procedures in accordance with Article 553 of the Federal Administrative Procedures Act. On the other hand, the interpretation regulation, which is "the regulation established by the Administration for the simple interpretation of statutes," does not require prior notice or comment because it does not affect the people's rights obligations. The Azar v. Allina Health Service, 587 U.S. 1804, 2019 ruling by the U.S. Constitutional Court, subject to this research paper, is about a dispute over a new decision to require Medicare to determine the amount of compensation for care providers that provide medical services for the poor, and should the regulations be regarded as substantive under the Administrative Procedures Act and should not be given a hearing or a simple internal process for processing. Given that the current administrative procedure law of our country stipulates the procedures for administrative pre-announcement through Articles 42.1 and 44.1, but that our courts have not judged violations of legislative pre-announcement procedures under the Administrative Procedures Act so far as to judge the illegality of administrative legislation, the dispute of the U.S. Constitutional Court will provide new implications for controlling legal orders beyond simple legal interpretation and has great significance in terms of readjustment of relevant regulations under future administrative procedures.

A Systematic Review and Meta-Analysis on the Correlation between Learning Satisfaction and Academic Achievement (학습자의 교육훈련 만족도와 학업성취도의 상관관계에 관한 체계적 문헌고찰과 메타분석)

  • Jeong, Sun-jeong;Rim, Kyung-hwa
    • Journal of vocational education research
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    • v.37 no.2
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    • pp.39-75
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    • 2018
  • The purpose of this study is to verify the general characteristics in the previous studies and the magnitude of the correlation between the learner's satisfaction and the academic achievement in the education and training program. To do this, we searched relevant literature from 2000 to 2016, and conducted a systematic review of the literature on the final 31 studies through the selection criteria and quality evaluation. Among them, 27 meta-analysis of the literature was conducted. The finding of the study were as follows. First, a total of 31 studies were conducted from 2000 to 2016, and more than half of them(16) were conducted for the last 4 years(2009~2012). In terms of education and training students, there are 18 college students, 9 workers, and 4 elementary students in order of study. In terms of methods, 15 collective education, 14 distance education, 2 blended education. In terms of learner's participation, 22 the general participation, 9 the active participation. Second, as a result of the meta-analysis, the magnitude of the correlation between satisfaction and achievement was moderate(ZCOR=.297, 95%: CI .210~.383). Third, as a result of verifying the difference in the magnitude of the correlation effect between satisfaction and achievement according to the characteristics of the education and training program, there was no difference between the groups in the student object and education method, but there was a difference in the magnitude of the correlation effect depending on the participant type(Q=15.40, df=1, p<.0001). The active participation showed a correlation effect size larger(ZCOR=.588, 95%: CI .422~.754). The effect size of the general participation was lower than the median(ZCOR=.211, 95%: CI .12 ~.300).

A Study on the Impact of Venture Capital Investment Experience and Job Fit on Fund Formation and Investment Rate of Return (벤처캐피탈의 투자경험과 직무적합도가 펀드결성과 투자수익률에 미치는 영향력에 관한 연구)

  • Kim Dae-Hee;Ha Kyu-So
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.18 no.4
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    • pp.37-50
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    • 2023
  • Venture capital invests the necessary capital and supports management and technology in promising small and medium-sized venture companies in the early stages of start-up with promising technology and excellent manpower. It plays a role as a key player in the venture ecosystem that realizes profits by collecting the investment through various means after growth. Venture capital's job is to recruit various investors(LPs) to invest in small and medium-sized venture companies with growth potential through the formation of venture investment funds, and to collect investment as companies grow, distribute and reinvest. The main tasks of venture capitalists, which play the most important role in venture investment, are finding promising companies, corporate analysis and evaluation, investment screening, follow-up management, and investment recovery. Venture capital's success indicators are fund formation and return on investment, and venture capitalists are rewarded with annual salary, performance-based incentive, and promotion with work performance such as investment, exit, and fund formation. Compared to the recent rapidly growing venture investment market, investment manpower is insufficient, and venture capital is making great efforts to foster manpower and establish infrastructure and systems for long-term service, but research has been conducted mainly from a quantitative perspective. Accordingly, this study aims to empirically analyzed the impact of investment experience, delegation of authority, job fit, and peer relationships on fund formation and return on investment according to the characteristics of the venture capital industry. The results of these empirical studies suggested that future venture capital needs a job environment and manpower operation strategy so that venture capitalists with high job fit and investment experience can work for a long time.

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The Behaviors of Phosphorus-32 and Ptoassium-42 under the Control of Thermoperiod and Potassium Level (가리(加里)와 온도주기성(溫度週期性)이 고구마 생육(生育) 및 인(燐)-32, 가리(加里)-42 동태(動態)에 미치는 영향(影響))

  • Kim, Y.C.
    • Korean Journal of Soil Science and Fertilizer
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    • v.1 no.1
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    • pp.89-115
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    • 1968
  • 1. The experiment was carried out for investigating the interaction between potassium nutrition and thermoperiod (as an environment regulating factor) in relation to behaviors of several nutrients including phosphorus-32 and Potassium-42 in IPOMOEA BATAS. 2. To obtain same condition to trace the behaviors of phosphorus and potassum-42 they were simultaneously incorporated to roots. The determination of each CPM by counting twice with adequate interval and calculating true CPM of each isotope according to different half-life, was carried out with satisfactory. 3. Some specific symptoms i.e, chlorosis and withering of growing point under the condition of lower potassium level were found and was accelerated by the low night temperature. 4. A manganese shortage in growing point of the lower potassium level was found by activiation analysis and very low distribution ratio of phosphorus-32 and potassium-42 in the growing point of the lower potassium level was manifested, though the contents of nitrogen, phosphorus, potassium, sodium and magnesium were not in great difference. 5. In addition to the low water content with appearence of "hard", shorterning internode and lower ratio of roots to shoot as well as the symptoms of potassium deficiency such as brown spot in leaf blade and necrosis of leaf margin were appeared at later stage of experiment at the lower potassium level. 6. Very stimulating vegetative growth, e.g, large plant length, leaf expansion, increasing node number and fresh weight as well as high ratio of roots to shoot, high water content was resulted in the condition of higher potassium level. 7. A specific interaction between higher potassium level and thermoperiod was found, that is, the largest tuber production and the largest ratio of roots to shoot were resulted in the combined condition of higher potassium level and constant temperature while the largest plant length, fresh weight etc. i.e. the most stimulative vegetative growth was resulted in the combined condition of higher potassium level and low night temperature. 8. Comparatively low water content in the former condition of stimulative tuber production was resulted(especially at the tuber thickening stage), while high water content in the latter condition of stimulative vegetation was resulted though the higher potassium level made generally high water contents. 9. The nitrogen contents of soluble and insoluble did not make distinct difference between the lower and higher potassium level. 10. Though the phosphorus contents were not distinctly different by the potassium level, the lower potassium level made the percentage of phosphorus increased at tuber forming stage accumulating more phosphorus in roots, while the higher potassium level decreased percentage of phosphorus at that stage. 11. The higher potassium level made distinctly high potassium contents than the lower potassium level and increased contents at the tuber forming stage through both conditions. 12. The sodium contents were low in the condition of higher potassium level than the lower potassium level and decreased at tuber forming stage in both conditions, on the contary of potassium. 13. Except the noticeable deficeney of manganese in the growing point of the lower potassium level, mangense and magnesium contents in other organs did not make distinct difference according to the potassium level. 14. Generally more uptake and large absorption rate of phosphorus-32 and potassium-42 were resulted at the higher potassium level, and the most uptake, and the largest absorption rate of phosphorus and potassium-42 (especially potassium-42 at tuber forming stage) were resulted in the condition of higher potassium level and constant temperature which made the highest tuber production. 15. The higher potassium level stimulated the translocation of phoshorus-32 and potassium-42 from roots to shoots while the lower potassium level suppressed or blocked the translocation. 16. Therefore, very large distribution rate of $p^{32}$, $K^{42}$ in shoot, especially, in growing point, compared with roots was resulted in the higher potassium level. 17. The lower potassium level suppressed the translocation of phosporus-32 from roots to shoot more than that of potassium-42. 18. The uptake of potassium-42 and translocation in IPOMOEA BATATAS were more vivid than phosphorus-32. 19. A specific interaction between potassium nutrition and thermoperiod which resulted the largest tuber production etc. was discussed in relation to behaviors of minerals and potasium-42 etc. 20. Also, the specific effect of the lower and higher potassium level on the growth pattern of IPOMOEA BATATAS were discussed in relation to behaviors of minerals and isotopes. 21. An emphasize on the significance of the higher potassium level as well as the interaction with the regulating factor and problem of potassium level (gradient) for crops product ion were discussed from the point of dynamical and variable function of potassium.

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