• Title/Summary/Keyword: pre-approval

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Definition of Security Requirement in Access Control (접근 통제의 보안 요건 정의)

  • Shin, Seong-Yoon;Kim, Chang-Ho;Jang, Dai-Hyun;Lee, Hyun Chang;Rhee, Yang-Won
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2014.05a
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    • pp.192-193
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    • 2014
  • Attendant services (user) roles (Role) and act on the data used should be based access control and permissions. Large amounts of important information to view and change the pre-approval must be acquired. Non-constant time for the session must control actions.

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A Study on the Improvement of Motor Vehicles Safety Certification System According to the Deployment of Autonomous Vehicle (자율주행자동차 상용화에 따른 자동차 안전 인증제도 개선에 관한 연구)

  • Yong Hyuk, Cho;Jeong Ah, An;Sang Hyun, Lee
    • Journal of Auto-vehicle Safety Association
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    • v.14 no.4
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    • pp.106-112
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    • 2022
  • The purpose of this study is to explore ways of improving the motor vehicles safety certification system in preparation for the deployment of Lv.4 or higher autonomous vehicles. In order to effectively achieve the objectives of this study, theoretical and empirical research methodologies were employed, including literature review of prior research, government-published data, etc.; comparative research on legislative cases of other countries regarding motor vehicles safety certification; historical and legal research on domestic systems; legal analysis to explore approaches for improvement, etc. Some argue that the type approval system is needed in preparation for deploying autonomous vehicles, but there are several limitations in moving to the type approval system from the self-certification system currently adopted in Korea. First, there is a possibility that the system may be in conflict with the Korea-U.S. MOU regarding Foreign Motor Vehicles (1988) and the Korea-U.S. FTA (2011); second, there is a risk of undermining the cause of the self-certification system, which is the autonomy of manufacturers; third, the boundary between autonomous vehicles and non-autonomous vehicles is unclear; and fourth, the type approval system may hinder technological competitiveness. On the other hand, considering that the Korea-U.S. FTA and the UNECE IWVTA recognize exceptions to deal with road safety and risks to human health or the environment, and have a pre-certification system for some auto parts such as pressure-resistant containers, it can be said that there is room to introduce the type approval system for supplementation purposes. To improve the motor vehicles safety certification system while ensuring the safety of autonomous vehicles of Lv.4 or higher, the targets of type approval should be defined and the criteria, procedures, etc. for type approval should be established. At the same time, the consistency between motor vehicle-related laws and harmonization with international standards need to be considered.

A Study of Clothing Behavior According to the Self-Esteem, Body Cathexis Between Multicultural and Korean Family Adolescents (다문화가정과 한국가정 청소년의 자아존중감과 신체만족도에 따른 의복행동특성에 관한 비교연구)

  • Kim, Tae-Mi;Choi, In-Ryu
    • Journal of the Korea Fashion and Costume Design Association
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    • v.13 no.3
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    • pp.69-80
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    • 2011
  • The purpose of this study was to clothing behavior according to the self-esteem, body cathexis in multicultural familie adolescents. The data was collected by using questionnaire survey based on pre-tests, and main survey conducted in Seoul, Gyeonggi province and Chungcheong province. The 236 participants came from 135 multicultural families and 101 Korean Self-esteem, body cathexis, clothing behavior were examined through 5-point likert scale. 3 factors including clothing interest, social approval and clothing conformity were used as clothing behavior. The analysis of the collected data was conducted by using SPSS 18.0. The results of this study is as follows: First, multi-cultural family adolescent showed higher self-esteem, body cathexis, than Korean family adolescent. Second, self-esteem were positively correlated, with body cathexis in both multi-cultural family and Korean family adolescent. Third, in multi-cultural family adolescent, body cathexis were positively correlated with clothing interest, social approval and clothing conformity. In Korean family adolescent, body cathexis were positively correlated with social approval and body cathexis were negatively correlated with clothing conformity.

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Comparison of Approval Process for Nonprescription Drugs in Different Countries (비처방의약품 허가 제도의 국가별 비교 연구 및 고찰)

  • Kim, Joo Hee;Yee, Jeong;Lee, Gwan Yung;Lee, Kyung Eun;Gwak, Hye Sun
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.263-272
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    • 2018
  • Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

The Study on the Improvement Policy of the Pre and Post Regulation System of Radio Station (무선국 관리 사전규제 개선과 사후관리 효율화 방안에 대한 연구)

  • Kim, Ho-Yeong
    • The Journal of the Korea institute of electronic communication sciences
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    • v.17 no.5
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    • pp.745-758
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    • 2022
  • As the unlimited natural source of a country, radio waves are widely being used in the daily life toward knowledge based information society. Therefore it is necessary to provide a long term policy of radio waves management policies based on market situation to cope with rapidly changing wireless technology and effective use of radio resources. Literary survey and analysis were accomplished for the rules and regulations in the radio station approval system and post-approval policies for mobile communication service. In conclusion, this study propose an blanket radio approval policy as well as self declaration of conformity(SDoC) of radio waves technical regulation and advanced radio inspection procedure. This study has significance in providing reference for introducing deregulation policy in the radio communication imdustry.

Adverse Drug Reaction Surveillance System in Korea (우리나라 약물유해반응 감시체계)

  • Choi, Nam-Kyong;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.40 no.4
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    • pp.278-284
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    • 2007
  • Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

Consultation Program for Pharmaceutical Development-Lessons from Foreign Countries' Experiences (주요국의 의약품 사전상담제도 현황과 정책적 함의)

  • Park, Syl-Vi-A;Park, Eun-Ja;Han, Hyun-Jin
    • YAKHAK HOEJI
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    • v.52 no.2
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    • pp.151-159
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    • 2008
  • Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.

Development of Pre-Environmental Investigation GIS Decision Making System Using Spatial Analysis Technique (공간분석기술을 활용한 사전환경성 검토 GIS 의사결정시스템 개발)

  • Kim, Sang Seok;Jang, Yong Gu;Kang, In Joon
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.26 no.1D
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    • pp.185-193
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    • 2006
  • The on-going pre-environmental investigation at present is performed by separate numerical analysis of each provision which makes integrated pre-environmental investigation is difficult. The application of numerical data is insufficient, which results to the deterioration of environmental investigation result's objectivity. A lot of time and money is required for the investigation. In this study, the spacial analysis function of GIS was applied on the 8 pre-environmental investigation factors. Pre-environmental investigation GIS DMS(Decision Making System) was constructed to make integrated investigation possible through the use of investigation results for each factor. Through the use of the developed pre-environmental investigation GIS DMS and the pre-constructed GIS data, the objectivity of environmental investigation is sufficient and time and cost are reduced. Therefore, this system can be used for pre-environmental investigation during route selection in the initial stages of road construction. Through the numerical and visual data obtained from the system developed in this paper, it is easier to gain the approval of the public. Furthermore, environmental problems due to road construction can be investigated with less time and money during the initial stages of road construction.

Antisense Oligonucleotide Therapeutics for Cystic Fibrosis: Recent Developments and Perspectives

  • Young Jin Kim;Adrian R. Krainer
    • Molecules and Cells
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    • v.46 no.1
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    • pp.10-20
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    • 2023
  • Antisense oligonucleotide (ASO) technology has become an attractive therapeutic modality for various diseases, including Mendelian disorders. ASOs can modulate the expression of a target gene by promoting mRNA degradation or changing pre-mRNA splicing, nonsense-mediated mRNA decay, or translation. Advances in medicinal chemistry and a deeper understanding of post-transcriptional mechanisms have led to the approval of several ASO drugs for diseases that had long lacked therapeutic options. For instance, an ASO drug called nusinersen became the first approved drug for spinal muscular atrophy, improving survival and the overall disease course. Mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene cause cystic fibrosis (CF). Although Trikafta and other CFTR-modulation therapies benefit most CF patients, there is a significant unmet therapeutic need for a subset of CF patients. In this review, we introduce ASO therapies and their mechanisms of action, describe the opportunities and challenges for ASO therapeutics for CF, and discuss the current state and prospects of ASO therapies for CF.

OPPORTUNITIES FOR IT IN CONSTRUCTION INDUSTRY OF IRAN

  • A. Hemmati;Kheyroddin
    • International conference on construction engineering and project management
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    • 2007.03a
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    • pp.424-432
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    • 2007
  • The last twenty-five years have seen dramatic improvements in and widespread use of IT to describe and document the work of the many disciplines involved in construction projects. Iran is a developing country and construction is a basic factor of developing too. Hence, the country needs to a special programming for construction of buildings, structures and infrastructures. Many parts of Iran are located in highly seismic zones and structures must be constructed safe e.g., according to recent seismic codes. In this paper opportunities of IT in construction industry of Iran are investigated in three categories. Pre-construction phase, construction phase and earthquake disaster mitigation are studied. Studies show that information technology can be used in these items for reducing the losses and increasing the benefits. Both government and private sectors must contribute to this strategic project for obtaining the best result.

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