• Title/Summary/Keyword: Regulation Recognition

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Changes and Perspects in the Regulation on Medical Device Approval Report Review, etc. : Focus on Traditional Korean Medical Devices (의료기기 허가·신고·심사 등에 관한 규정 변화와 전망 : 한의 의료기기 중심으로)

  • DaeJin Kim;Byunghee Choi;Taeyeung Kim;Sunghee Jung;Woosuk Kang
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.1
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    • pp.31-42
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    • 2024
  • Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

Roles of Conceptus Secretory Proteins in Establishment and Maintenance of Pregnancy in Ruminants

  • Bazer, Fuller W.;Song, Gwon-Hwa;Thatcher, William W.
    • Asian-Australasian Journal of Animal Sciences
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    • v.25 no.1
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    • pp.1-16
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    • 2012
  • Reproduction in ruminant species is a highly complex biological process requiring a dialogue between the developing conceptus (embryo-fetus and associated placental membranes) and maternal uterus which must be established during the peri-implantation period for pregnancy recognition signaling and regulation of gene expression by uterine epithelial and stromal cells. The uterus provide a microenvironment in which molecules secreted by uterine epithelia and transported into the uterine lumen represent histotroph, also known as the secretome, that are required for growth and development of the conceptus and receptivity of the uterus to implantation by the elongating conceptus. Pregnancy recognition signaling as related to sustaining the functional lifespan of the corpora lutea, is required to sustain the functional life-span of corpora lutea for production of progesterone which is essential for uterine functions supportive of implantation and placentation required for successful outcomes of pregnancy. It is within the peri-implantation period that most embryonic deaths occur in ruminants due to deficiencies attributed to uterine functions or failure of the conceptus to develop appropriately, signal pregnancy recognition and/or undergo implantation and placentation. The endocrine status of the pregnant ruminant and her nutritional status are critical for successful establishment and maintenance of pregnancy. The challenge is to understand the complexity of key mechanisms that are characteristic of successful reproduction in humans and animals and to use that knowledge to enhance fertility and reproductive health of ruminant species in livestock enterprises.

Design and Implementation of Vocal Sound Variation Rules for Korean Language (한국어 음운 변동 처리 규칙의 설계 및 구현)

  • Lee, Gye-Young
    • The Transactions of the Korea Information Processing Society
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    • v.5 no.3
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    • pp.851-861
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    • 1998
  • Korean language is to be characterized by the rich vocal sound variation. In order to increase the probability of vocal sound recognition and to provide a natural vocal sound synthesis, a systematic and thorough research into the characteristics of Korean language including its vocal sound changing rules is required. This paper addresses an effective way of vocal sound recognition and synthesis by providing the design and implementation of the Korean vocal sound variation rule. The regulation we followed for the design of the vocal sound variation rule is the Phonetic Standard(Section 30. Chapter 7) of the Korean Orthographic Standards. We have first factor out rules for each regulations, then grouped them into 27 groups for eaeh final-consonant. The Phonological Change Processing System suggested in the paper provides a fast processing ability for vocal sound variation by a single application of the rule. The contents of the process for information augmented to words or the stem of innected words are included in the rules. We believe that the Phonological Change Processing System will facilitate the vocal sound recognition and synthesis by the sentence. Also, this system may be referred as an example for similar research areas.

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A Study on the Recognition and Enforcement of Arbitral Awards Applied Public Policy by Chinese Court (중국 법원의 중재판정 승인 및 집행에서 공공질서 적용에 관한 연구)

  • Ha, Hyun-Soo
    • Journal of Arbitration Studies
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    • v.21 no.3
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    • pp.115-136
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    • 2011
  • In the past, Chinese arbitral system and Chinese arbitral associations were avoided by international society due to the cases which Chinese court rejected the recognition and enforcement of foreign arbitral awards based on rural protection. Especially Chinese court adjudicated to reject the recognition and enforcement of arbitral awards by interpreting public policy broadly. The abuse of public policy by court threats the existence of commercial arbitration system. Under this awareness, the author figured out Chinese court shows what kind of attitude about public policy of Chinese court in the present through analyzing the cases about rejection of enforcement in Chinese arbitral awards in order to analyze whether Chinese court still maintain the negative attitude like past or there exist changes with public policy which is one of the rejection reasons of recognition and enforcement in foreign arbitral awards as the central figure. Chinese court behaved in an uncooperative attitude about arbitral awards like that it reached a verdict to reject the enforcement of arbitral awards by reason of violation in public policy about several foreign arbitral awards at the beginning stage of establishing arbitration law. However, the situation of abuse in public policy was improved a lot by Chinese prime court which enforces pre-inspection system about judgment of rejection of enforcement in arbitral awards. So, there is no case about rejecting the approval and enforcement of arbitral awards by reason of violation in public policy by Chinese court except Yongning Co. case. Moreover, Chinese court got the trust and support from other countries through reinforcement of applied standard. However, Chinese court had been expressed concern from international society because they highly applied public policy and rejected to enforce arbitral awards in the recent case of Yongning Co.. Therefore, this study examined whether it is appropriate to apply public policy of Chinese court in the case of Yongning Co., and then I concluded that. Although Yongning Co. case is the first case which Chinese prime court agrees with public policy by reason of rejection of approval and enforcement in foreign arbitral awards, in my opinion, it doesn't mean that Chinese court has fundamental change in basic attitude and position about the approval and enforcement of foreign arbitral awards. Chinese court keeps the cautious uses of public policy in legal judgment of foreign arbitral awards and it looks like implementing the obligation in regulation of New York Convention sincerely.

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Regulation of Melanosome Transfer to and Distribution in Keratinocytes

  • Boissy, Raymond E.;Minwalla, Ljiljana
    • Journal of Photoscience
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    • v.9 no.2
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    • pp.213-216
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    • 2002
  • Skin pigmentation, also known as complexion coloration, results from the biosynthesis of melanin within the melanocytes of the Stratum basalum and the subsequent transfer, translocation, and degradation of this pigment to, in, and by the neighboring keratinocytes respectively, Melanins are produced and retained in melanosomes synthesized in the cell body that are translocated along the dendrites using microtubules via motor proteins. Melanosomes are eventually captured and retained at the tips of dendrites by attachment to the peripherally localized actin. Melanosomes reaching the dendritic tips are transferred to keratinocytes, primarily via phagocytosis of released melanosomes by keratinocytes. Molecules responsible for cell/cell recognition and interaction that regulate transfer are being identified. Some of these putative mediators appear to be affected by ultraviolet radiation. After the keratinocytes receive melanosomes, the granules are distributed individually or as clusters in dark versus light skin respectively. These melanosomes are then aggregated over the nucleus for photoprotection ofkeratinocyte DNA and eventually degraded.

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Innate immune response to oral bacteria and the immune evasive characteristics of periodontal pathogens

  • Ji, Suk;Choi, Youngnim
    • Journal of Periodontal and Implant Science
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    • v.43 no.1
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    • pp.3-11
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    • 2013
  • Periodontitis is a chronic inflammation of periodontal tissue caused by subgingival plaque-associated bacteria. Periodontitis has long been understood to be the result of an excessive host response to plaque bacteria. In addition, periodontal pathogens have been regarded as the causative agents that induce a hyperinflammatory response from the host. In this brief review, host-microbe interaction of nonperiodontopathic versus periodontopathic bacteria with innate immune components encountered in the gingival sulcus will be described. In particular, we will describe the susceptibility of these microbes to antimicrobial peptides (AMPs) and phagocytosis by neutrophils, the induction of tissue-destructive mediators from neutrophils, the induction of AMPs and interleukin (IL)-8 from gingival epithelial cells, and the pattern recognition receptors that mediate the regulation of AMPs and IL-8 in gingival epithelial cells. This review indicates that true periodontal pathogens are poor activators/suppressors of a host immune response, and they evade host defense mechanisms.

Lane Positioning in Highways Based on Road-sign Tracking by Kalman Filter (칼만필터 기반의 도로표지판 추적을 이용한 차량의 횡방향 위치인식)

  • Lee, Jaehong;Kim, Hakil
    • Transactions of the Korean Society of Automotive Engineers
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    • v.22 no.3
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    • pp.50-59
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    • 2014
  • This paper proposes a method of localization of vehicle especially the horizontal position for the purpose of recognizing the driving lane. Through tracking road signs, the relative position between the vehicle and the sign is calculated and the absolute position is obtained using the known information from the regulation for installation. The proposed method uses Kalman filter for road sign tracking and analyzes the motion using the pinhole camera model. In order to classify the road sign, ORB(Oriented fast and Rotated BRIEF) features from the input image and DB are matched. From the absolute position of the vehicle, the driving lane is recognized. The Experiments are performed on videos from the highway driving and the results shows that the proposed method is able to compensate the common GPS localization errors.

A Study on Driving Control using Neural Network Identifier (신경회로망 동정기를 이용한 AGV의 주행제어에 관한 연구)

  • 이영진;이진우;손주한;최성욱;김한근;조현철;이권순
    • 제어로봇시스템학회:학술대회논문집
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    • 2000.10a
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    • pp.151-151
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    • 2000
  • The objective of this paper is to develop the new robust and adaptive control system against external environments as applying the probabilistic recognition which is one of the inherent properties of immune system, ability of learning and memorization, and regulation theory of immune network to the system under engineering point of view. In this paper, HIA(Humoral Immune Algorithm) PID controller using Neural Network Identifier was proposed to drive the autonomous guided vehicle(AGV) more effectively. To verify the performance of the proposed HIA PID controller, some experiments for the control of steering and speed of that AGV are performed.

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Autophagy as an Innate Immune Modulator

  • Oh, Ji Eun;Lee, Heung Kyu
    • IMMUNE NETWORK
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    • v.13 no.1
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    • pp.1-9
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    • 2013
  • Autophagy is a fundamental cellular process in eukaryotic cells for maintaining homeostasis by degrading cellular proteins and organelles. Recently, the roles of autophagy have been expanded to immune systems, which in turn modulate innate immune responses. More specifically, autophagy acts as a direct effector for protection against pathogens, as well as a modulator of pathogen recognition and downstream signaling in innate immune responses. In addition, autophagy controls autoimmunity and inflammatory disorders by negative regulation of immune signaling. In this review, we focus on recent advances in the role of autophagy in innate immune systems.

A Study on Children's Emotional Intelligence and Related Variables (아동의 정서지능과 관련변인들에 관한 연구)

  • Lee, Ju Lie
    • Korean Journal of Child Studies
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    • v.23 no.3
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    • pp.65-78
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    • 2002
  • This study investigated causality in children's emotional intelligence and sociodemographic variables, including family structure, number of siblings, home environment and peer group variables. Subjects were 301 elementary and junior high 11-and 13-year-olds and their mothers. Instruments were questionnaires from the Children's Emotional Intelligence Scale. Data analysis was by Pearson's r, Cronbach's ${\alpha}$, multiple regression and path analysis. Results showed that the variables that affected emotional recognition directly were age, sex, mother's education, economic status of the home, number of siblings, and emotional support of peers. Variables that affected emotion regulation directly were sex, economic status of the home, emotional support of peers, and common activity. Variables that affected emotional facilitation of thinking directly were age, sex, emotional support of peers, and common activity.

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