• Title/Summary/Keyword: certification history

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The History of Korean GMP (우리나라 GMP 변천사)

  • Paik, Woo-Hyun
    • YAKHAK HOEJI
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    • v.59 no.1
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    • pp.40-46
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    • 2015
  • The term "GMP" firstly came on the 1962 amendment of the Federal Food, Drug and Cosmetic (FD&C) Act and the US FDA established and officially announced the Good Manufacturing Practice Regulation for the first time in the world in 1963. In 1969, the World Health Organization published the GMP regulation and recommended that member states adopt the GMP regulation and implement the "GMP Certification Scheme" for international commerce of finished pharmaceutical products. As a result, GMP requirements have become important ones that have to be complied with in the manufacture of pharmaceutical products. The Korean GMP regulation was announced as the official notification by the Ministry of Health and Social Affairs in 1977. The KGMP regulation was voluntarily adopted by pharmaceutical companies at the early stage, but it had become mandatory. In addition, various kinds of GMP regulations have been established to cover active pharmaceutical ingredients, biological products and others, in addition to finished pharmaceutical products. Taking account of technological development and changes in the pharmaceutical environments, the KGMP regulation was fully amended and harmonized with GMP requirements of developed countries. In this way, the KGMP has developed to keep up with international trends and standards, leading to accession to the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

A Case Study on the Havruta Method in the Reading the Chinese Classics (하브루타를 적용한 경전강독 수업 사례 연구)

  • LEE Hae-deum;KIM Yong-jin
    • The Journal of Korean Medical History
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    • v.36 no.2
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    • pp.89-98
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    • 2023
  • Objectives: This study applied Havruta, a learner-centered educational method, and verified its effectiveness, to break from the existing mechanical memorization methods of scripture reading classes, which are basic subjects of East Asian medicine at East Asian medicine universities. Method: To this end, D University's scripture reading course was redesigned according to Havruta's teaching model, and Havruta classes were conducted according to the instructional design. Results: As a result of the class, students' Chinese translation ability improved, and they were able to concentrate on class (M=4.24). Through class, they acquired knowledge in the field (M=4.21) and their ability to communicate with others improved (M=4.21). M=4.25), it can be inferred and interpreted that the learner is engaged. Conclusion: The results of this study are examples of applying various teaching and learning methods required in the East Asian medicine evaluation and certification of East Asian medicine at East Asian medicine universities, and can be used as practical basic data that can be applied not only to scripture reading subjects but also to other subjects.

A Study on the DID based Smart Remocon and FIDO Transaction Certification for Home-shopping (DID 기반의 스마트 리모콘과 홈쇼핑 FIDO 거래인증 연구)

  • Yeo, Hyupgoo;Kang, Mingoo;Sonh, Seungil
    • Smart Media Journal
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    • v.9 no.1
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    • pp.60-66
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    • 2020
  • In this paper, the FIDO (Fast IDentity Online) transaction certification platform was proposed for applying the DID (Decentralized ID) of blockchain with home shopping channels to the IPTV service providers based on the Remocon (Remote Control). In this case, the DID based smart remocon applies biometric identification techniques for personal identification. These individual DID smart remote controls apply distributed ID blockchain, enabling home shopping viewers to conduct reliable ratings surveys through the detection of channel changed information. In addition, this smart remocon utilizes the product purchased information history on home shopping channels, allowing IPTV's home shopping viewers to compare the same broadcasted production information on all channels by blockchain technique and their production characteristics. IPTV service providers can process home shopping order/authorization informations in one-stop service via a number of home shopping broadcasting companies, and DID smart remote controls for home shopping viewers with the checking results of their real-time online access to confirm the FIDO2.0 transaction certification homepage. Thus, the FIDO transaction authentication platforms of IPTV service provider(Telecommunication company) can be expected to improve the benefits of home shopping customers, and to reduce the broadcasting companies' burden of payment, too.

The Access Network Architecture for BcN Adapted (BcN 적합형 액세스네트워크 구조)

  • Lee, Sang-Moon
    • 한국정보통신설비학회:학술대회논문집
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    • 2007.08a
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    • pp.121-124
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    • 2007
  • This article describes a function and structure of access network equipment under BcN environment. Access network until now have constructed separately to offer voice, data service. However, simplifies network structure, function that can do traffic concentration, subscriber certification, individual charging, QoS according to service and routing is required in BcN. In this paper, compare method offering by separate system with existing access network and method that offer integrating function inside system for structure of suitable access network to BcN and search structure of access network equipment for desirable access network of hereafter. Composition of this paper is as following. In Chapter 2, establishment history and structure of access network until present. In Chaprte 3, define suitable requirement and functions to BcN. And compare structure for access net work that is new with present. Last Chapter 4, suggests direction of structure of BcN access network and concludes conclusion.

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Evaluation of the Clinical Effectiveness of Laser Acupuncture for Disease Specific : Systematic Reviews and Meta-analyses (질환별 레이저 침의 임상적 효과 평가 : 체계적 문헌고찰 및 메타분석)

  • DaeJin Kim;Byunghee Choi;Taeyeung Kim;Sukang Park;Jinyoug Kwak
    • Journal of Biomedical Engineering Research
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    • v.45 no.2
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    • pp.81-89
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    • 2024
  • Purpose : This study conducted a systematic review and meta-analysis to evaluate the clinical effectiveness of laser acupuncture for each condition using information from laser acupuncture trials registered on clinicaltrials.gov from January 2013 to June 2023. Methods : We quantitatively and qualitatively analysed the results of 16 clinical trials of laser acupuncture whose research results were confirmed. A risk of bias assessment was also carried out to assess the quality of each clinical trial. Results : A meta-analysis including three clinical trials was conducted to evaluate the comparative effectiveness of laser acupuncture and sham laser acupuncture in reducing pain and found that the laser acupuncture group had a statistically significant reduction in pain compared with the sham laser acupuncture group. In addition, 11 of the 13 trials not included in the meta-analysis showed a positive effect of laser acupuncture. Conclusion : Although laser acupuncture has a long history of clinical use and a lot of research, there is still some scepticism due to the lack of a clear mechanism of action and inconsistent reports of clinical effectiveness. In addition, there is a significant lack of systematic reviews of clinical evidence for major disease specific, and ongoing research is needed to establish an objective evidence base for the clinical effectiveness of laser acupuncture.

A Study on Employment Channels to Find A Way for Practical Music Students -About the Need and the Direction of Use of The Certification- (실용음악 전공학생들의 취업 활로 모색에 관한 고찰 -자격증의 필요성과 활용 방향에 대하여-)

  • Kim, Hyeong-Chun;Cho, Tae-seon
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.22 no.1
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    • pp.379-384
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    • 2021
  • Despite the numerous graduates being produced in practical music and history, which have not been shorter than 30 years, the employment of students remains an unsolvable task. Most graduates are employed by private institutes as music instructors or got involved in band activities, which are non-regular work and not stable. The rapid development of K-pop along with national strength has changed our lives as well. As a result, the cultural and artistic fields, which were previously recognized only as luxury, have rapidly become popular. In the form of learning, internalized and experiencing, not just watching has a huge impact on improving the quality of our lives. This is reflected in national policies including the operation of cultural arts, education programs in elementary, middle, and high schools, and art programs designed to improve the welfare of residents at local community centers. It is time to expand its job-horizon to the relevant fields, and thus focus on promoting programs related to obtaining certificates to help our students find jobs. In addition, the government should create a course for music teacher certification in the field of practical music that differs from the current music teacher certification of secondary schools. It is very urgent to establish the teaching course in four-year universities or graduate schools of practical music education.

Current Issues and Tasks of Genetic Cancer Nursing in Korea (유전체학 시대의 한국 종양 유전 간호의 과제)

  • Jun, Myunghee;Choi, Kyung Sook;Shin, Gyeyoung
    • Asian Oncology Nursing
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    • v.12 no.4
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    • pp.267-273
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    • 2012
  • Purpose: The purpose of this review article is to introduce how the Korean Society of Genetic Nursing (KSGN) has evolved and tried to translate genomic knowledge to nursing practice, and then to suggest the future role of genetic nurses in Korea. Methods: A literature review was performed and the current status of genetic counselling in Korea was explored. Then the educational and clinical experiences of the authors were incorporated. Finally, the main activities of Korean nursing for genetics were identified. Results: Two types of genetic counsellor certification have been issued in Korea: one is issued by the Korean Society of Genetic Medicine, another by the Korean Society of Breast Cancer since June 2011. A few Korean nursing researchers have continuously performed research related to genetic nursing and undertook several research projects funded by the government since 2003. In February 2011, KSGN was established and is now trying to establish further international networks. Conclusion: Nursing genetic experts should be trained to integrate all specialties for genetic counselling, so they can provide holistic genetic services including ethical, legal, and social issues (ELSI).

A Study of Plans for the improvement of the domestic building maintenance system based on the comparison and analysis of foreign building maintenance systems (외국의 유지관리 제도 비교분석을 통한 국내 건축물 유지관리 개선 방안 연구)

  • Yoon, Hyo-Jin;Chung, Kwang-Ho
    • Journal of The Korean Digital Architecture Interior Association
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    • v.9 no.2
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    • pp.25-33
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    • 2009
  • So far we have investigate and analyzed the actual conditions of building maintenance in Korea and compared the building maintenance laws and systems between Korea and other countries. Now, based on the results from such comparison and analysis, this study proposes the following ideas for improvement: 1) As we can learn from domestic and foreign case studies, in the existing built-up areas becoming obsolete, many building owners remodel their buildings illegally in reaction to current economic and social changes. Therefore, for efficient maintenance of buildings, it is required to improve building maintenance systems by formulating information about inspection items, inspectors, supervisors, inspection costs and intervals of reporting results, depending on how large the buildings are and what they are used for. 2) In addition, to ensure the success of a building maintenance system, it is necessary to keep and manage a history of building maintenance thoroughly and introduce a certification program which gives an appropriate grade to maintenance performance and commits the government to expand their public roles and supporting policies, as widely used in some foreign countries. Further, in keep the building maintenance system secure, there should be a nationwide consensus as well as a favorable evaluation from building owners and manager, and all related people.

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A Design for a Hyperledger Fabric Blockchain-Based Patch-Management System

  • Song, Kyoung-Tack;Kim, Shee-Ihn;Kim, Seung-Hee
    • Journal of Information Processing Systems
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    • v.16 no.2
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    • pp.301-317
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    • 2020
  • An enterprise patch-management system (PMS) typically supplies a single point of failure (SPOF) of centralization structure. However, a Blockchain system offers features of decentralization, transaction integrity, user certification, and a smart chaincode. This study proposes a Hyperledger Fabric Blockchain-based distributed patch-management system and verifies its technological feasibility through prototyping, so that all participating users can be protected from various threats. In particular, by adopting a private chain for patch file set management, it is designed as a Blockchain system that can enhance security, log management, latest status supervision and monitoring functions. In addition, it uses a Hyperledger Fabric that owns a practical Byzantine fault tolerant consensus algorithm, and implements the functions of upload patch file set, download patch file set, and audit patch file history, which are major features of PMS, as a smart contract (chaincode), and verified this operation. The distributed ledger structure of Blockchain-based PMS can be a solution for distributor and client authentication and forgery problems, SPOF problem, and distribution record reliability problem. It not only presents an alternative to dealing with central management server loads and failures, but it also provides a higher level of security and availability.

Mock-Up Test for the Fire Resistance Analysis of High Strength RC Beam and Slab Using the Polylon Fiber (폴리론 화이버를 혼입한 고강도 RC 보 및 슬래브의 내화특성 분석을 위한 Mock-Up 실험)

  • Son, Ho Jung;Hwang, Dong Gyu;Hann, Chang Pyung;Han, Min Cheol;Yang, Seong Hwan;Han, Cheon Goo
    • Proceedings of the Korean Institute of Building Construction Conference
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    • 2009.11a
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    • pp.93-96
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    • 2009
  • The objective of this study is to analyze the insulation characteristics of the polylon hybrid fiber inserted high-strength RC beam and slab produced as a single body and the results of this study can be summarized as follows. In the spalling mechanism as an insulation characteristic, the slab of the single body type specimen shows an exposure in concrete covers at the center of slab and that leads to the spalling, which exposures reinforcing bars. In the case of the beam, the spalling was presented at several sections as a type of peel spalling before and after 10 minutes from the insulation test. Whereas, although the internal temperature history of concrete represents the highest range as 581℃ in the case of the center of the bottom of beam base, it can be considered that it satisfies the regulation of insulation certification.

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