• 제목/요약/키워드: Entry Regulation

검색결과 112건 처리시간 0.029초

치의학분야 3D 프린팅 기술이 적용된 의료기기의 인·허가전략과 과제 (Licensing strategies and tasks for medical devices utilizing 3D printing technology in dentistry)

  • 신은미;양승민
    • 대한치과의사협회지
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    • 제56권9호
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    • pp.479-490
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    • 2018
  • 3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

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HVEM is a TNF Receptor with Multiple Regulatory Roles in the Mucosal Immune System

  • Shui, Jr-Wen;Kronenberg, Mitchell
    • IMMUNE NETWORK
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    • 제14권2호
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    • pp.67-72
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    • 2014
  • The herpes virus entry mediator (HVEM) is a member of the tumor necrosis factor receptor superfamily (TNFRSF), and therefore it is also known as TNFRSF14 or CD270 (1,2). In recent years, we have focused on understanding HVEM function in the mucosa of the intestine, particularly on the role of HVEM in colitis pathogenesis, host defense and regulation of the microbiota (2-4). HVEM is an unusual TNF receptor because of its high expression levels in the gut epithelium, its capacity to bind ligands that are not members of the TNF super family, including immunoglobulin (Ig) superfamily members BTLA and CD160, and its bi-directional functionality, acting as a signaling receptor or as a ligand for the receptor BTLA. Clinically, Hvem recently was reported as an inflammatory bowel disease (IBD) risk gene as a result of genome wide association studies (5,6). This suggests HVEM could have a regulatory role influencing the regulation of epithelial barrier, host defense and the microbiota. Consistent with this, using mouse models, we have revealed how HVEM is involved in colitis pathogenesis, mucosal host defense and epithelial immunity (3,7). Although further studies are needed, our results provide the fundamental basis for understanding why Hvem is an IBD risk gene, and they confirm that HVEM is a mucosal gatekeeper with multiple regulatory functions in the mucosa.

A Comparative Study on the Distribution Regulation Policy in Korea and Foreign Countries

  • Park, Chul-Ju;Kim, Dae-Yun
    • 유통과학연구
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    • 제11권9호
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    • pp.43-49
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    • 2013
  • Purpose - The competitiveness of small- and medium-sized distribution companies has weakened with the entry of large distribution companies and Super Super Markets (SSMs). These companies have nationwide distribution networks and capital to take over street markets, thereby threatening the very survival of small merchants. In order to help these small- and medium-sized merchants, the government has recently reinforced distribution regulations for large distribution companies. Research design, data, methodology - The purpose of this study is to review domestic and foreign distribution regulations and to provide direction for establishing domestic distribution policies in the future. Results - The government must fully reassess its assistance policy for small and medium distribution companies to enable them to engage in differentiated competition with large retailers, based on their own strengths. This will allow all interested parties to coexist. Conclusions - Government assistance policies for small and medium distributors such as traditional markets must be reorganized. The objective is to ultimately protect small and medium distributors and allow them to coexist on their own strengths, rather than have regulations for large retail stores.

사회적 지지와 자기조절이 직무스트레스에 미치는 영향: 활동보조인을 중심으로 (Effects of Social Support and Self-Regulation on Job Stress: Focused on Personal Assistants for the Disabled)

  • 정명선;이경준;한건환
    • 한국산학기술학회논문지
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    • 제18권10호
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    • pp.265-273
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    • 2017
  • 본 연구는 활동보조인의 사회적 지지, 자기조절, 직무스트레스 간의 관련성에 초점을 두고, 특히 사회적 지지가 직무스트레스에 미치는 영향에 대한 자기조절 능력의 조절효과를 살펴보는 데 목적을 두었다. 이를 위해 총 330명의 활동보조인을 대상으로 사회적 지지, 자기조절, 직무스트레스에 관해 묻는 설문조사를 실시하였으며, 그중 276 사례를 최종분석에 사용하였다. 자료 분석을 위해서는 SPSS(PASW) 18.0과 SPSS용 PROCESS Macro를 사용하여 동시입력방식의 조절회귀분석이 이루어졌다. 본 연구의 결과는 다음과 같다. 첫째, 사회적 지지 및 자기조절은 직무스트레스의 감소에 기여하였다. 둘째, 자기조절은 사회적 지지와 직무스트레스와의 관계에서 조절효과를 가지는 것으로 나타났으며, 조절효과의 세 가지 기능 중 사회적 지지가 직무스트레스의 감소에 미치는 영향을 강화하였다. 끝으로 이러한 연구결과를 토대로 시사점과 제한점, 후속연구를 위한 제언을 제시하였다. 본 연구는 직무스트레스의 관리를 위해서는 장애인 활동보조서비스 현장에서 사회적 지지와 같은 외적 자원 외에도 자기조절과 같은 내적 자원이 필요함을 제안한다.

밀폐공간진입을 위한 가상현실(VR) 훈련의 효과 (Effect of Virtual Reality Training for the Enclosed Space Entry)

  • 채종주;이진우;정진기;안영중
    • 해양환경안전학회지
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    • 제24권2호
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    • pp.232-237
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    • 2018
  • 국제해양사고조사포럼(MAIIF)의 조사에 따르면 1998~2009까지 밀폐공간진입 시 발생한 101건의 사고에서 93명의 사망자와 96명의 부상자가 발생하였다. 이에 국제해사기구(IMO)는 밀폐공간진입을 위한 지침과 SOLAS 1974 협약 제3장 규칙 19를 개정하여 주기적으로 선박에서 밀폐공간진입 훈련을 시행하도록 강제화 하였다. 밀폐공간진입 훈련은 실제적이고 진입 시의 위험성을 인식할 수 있도록 실시되어야 하며, 훈련 중 훈련참가자나 교육생들의 안전도 고려되어야 한다. 최근에는 교육 및 훈련효과의 향상을 위해 가상현실(VR) 교육 컨텐츠들이 다양한 분야에서 이용되고 있으며, 이러한 방법은 장소의 제한 없이 실제적이고 반복적인 학습에 장점을 가지고 있다. 이에 본 연구에서는 VR을 이용한 밀폐공간진입 훈련이 강의형 교육훈련과 비교하여 어떤 효과와 특징 및 차별성이 있는지 훈련참가자들에 대한 정량적 평가와 설문을 통해 확인하였다. 평가 및 설문분석을 통해 VR을 이용한 밀폐공간진입 훈련 참가자들의 학습요소에 대한 숙지도가 강의형 교육훈련 참가자들보다 우수하였고, 교육방식에 대한 참가자들의 주관적 선호도도 VR을 이용한 훈련이 높게 나타났다. 연구결과 VR을 이용한 훈련의 학습효과를 확인할 수 있었으며, VR을 이용한 선상훈련은 동영상 및 시뮬레이터와 같이 효과적인 교육방식으로 이용될 수 있을 것이다.

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

  • 김대진;최병희;김태영;정성희;강우석
    • 대한예방한의학회지
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    • 제28권1호
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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.

건설감리업계 해외진출 전략 수립 방향 (Direction of Establishing Oversea's Market Entry Strategy for Construction Supervision Industry)

  • 오은호;박환표;한재구;진경호
    • 한국건축시공학회:학술대회논문집
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    • 한국건축시공학회 2011년도 추계 학술논문 발표대회
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    • pp.87-88
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    • 2011
  • Construction projects that should be under the construction supervision regulation were decreased in 2008 and new supervision projects in 2010 were significantly reduced by 60% comparing to the ones as of 2009. On the contrast, the volume of world construction projects including Middle·South Asia and Africa is forecasting to be increased by 46% in 2018. However, although the needs of oversea expansion of domestic construction supervision firms are appeared more and more, their preparations to the strategically important areas in the world are insufficient. Thus, this paper aims to suggest directions of strategics and plans for domestic construction supervision industry to expand the market to the world through questionnaire surveys and expert investigation.

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HVAC 파라미터 모니터링 시스템에 대한 고찰 (Computer Validation 중심으로) (A Study on HVAC Parameter Monitoring System (Regarding Computer Validation))

  • 김종구
    • 대한설비공학회:학술대회논문집
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    • 대한설비공학회 2008년도 하계학술발표대회 논문집
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    • pp.90-95
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    • 2008
  • This article presents practical advice regarding the implementation and management of an impeccable Building Management System. The BMS was introduced to the series of computerized systems including manufacturing, storage, distribution, and quality control. Recently revised GMP regulation is requesting an improvement in drug product quality regulatory system by computer system validation. Quality is critical to guarantee the efficacy and the safety of drugs and is approved in the evaluation process after the audit trail application. HVAC parameter monitoring system will record the identity of operators entering or confirming critical data. Authority to amend entered data should be restricted to nominated persons. Any alteration to an entry of critical data should be authorized in advance and recorded with the reason for the change.

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방송과 통신정책, IPTV 융합정책의 지대추구론적 분석 : 지대추구의 효율성 분석을 중심으로 (A Study on the Convergence Policy of Broadcasting and Telecommunication in IPTV Convergence Service with Reference to Rent Seeking Theory)

  • 이상호;김재범
    • Journal of Information Technology Applications and Management
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    • 제14권3호
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    • pp.199-225
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    • 2007
  • This study deals with the regulatory policy of government on the convergence of broadcasting and telecommunication by applying rent seeking theory to Internet Protocal TV (IPTV). Existing literature has mainly focused on the negative implications of rent seeking since Tullock [1967], Krueger [1974] and Buchanan [1980]. We have investigated the regulatory policy along with the progress of the convergence of broadcasting and telecommunication. Regulatory policy on broadcasting, despite its impartial intent. has created the entry barrier in the industry, resulting in high rents. Meanwhile, regulatory policy in telecommunication is more geared by the encouragement of more competitive environments, resulting in reasonably low rents in the market. Regulatory policy in the age of convergence needs to improve the efficacy of the industry and welfare, while maintaining the rent at a reasonably low level. This research has contributed to emphasizing the positive aspect of rent seeking in policy concerned with the convergence of broadcasting and telecommunication, notably IPTV.

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연안어업 어업허가 거래 실태와 개선 필요성에 대한 연구 (The Status and Improvement of the Fishing Boat Market in Korea Coastal Fishery)

  • 신용민
    • 수산경영론집
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    • 제44권1호
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    • pp.25-37
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    • 2013
  • The permit system is the most typical regulation system in Korean fishery. Even now, it has caused resource management failure, it has also invited economic inefficiency and inequity. Accordingly, the Korean government has recently introduced the fishing boats market, it would be improve entry barrier for new capital and labor in fishing industry. This study aims to survey and to analyze the status of coastal fishing boat market using the executive documents on permit system in Gyongnam province. And also, this study put focus on improve fishing permit trade take advantage of the fishing boat trading. The survey results indicated that the number of fishing boats trading is estimated about 5,000 per year, however, fishing boat market is very narrow. An analysis on fishing permit trading showed that policy support is essential to reduce transaction cost. Therefore, it is necessary to explore corresponding policy tasks, this will be reduce transaction costs and sunk cost.