• Title/Summary/Keyword: Regulatory Aspects

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Perspectives on Adopting the Guideline for Multi-regional Clinical Trials in Korea: A Multi-stakeholder Survey (한국의 다지역 임상시험 가이드라인 적용에 대한 인식: 다중 이해관계자 설문조사)

  • Sohn, Minji;Song, Yun-Kyoung;Jeon, Ah Young;Oh, Jung Mi;Kim, In-Wha
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.4
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    • pp.267-277
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    • 2019
  • Backgrounds: With the globalization of drug development, multi-regional clinical trials (MRCTs) have emerged to facilitate rapid availability of medicines to patients worldwide. The present study aimed to has explored attitudes and perceptions towards adopting the Korean MRCT guideline. Methods: An online survey, consisting of 16 questions, classified into two subjects, was administered to stakeholders in Korea. Most quantitative components were measured using the Likert scales. A content analysis of the qualitative components was carried out to identify the keywords in open-ended responses. Results: A total of 94 survey responses were analyzed: 51 participants from pharmaceutical companies, 11 from clinical research organizations, and 21 from clinical trial centers. The content of the guideline was rated as appropriate for clarity, acceptability, and applicability (96.8, 96.8, and 93.6%, respectively). The local environmental impact of the systemic/political, academic/technical, and industrial/economical aspects of the guideline was rated as appropriate at 95.7, 97.9, and 91.5%, respectively. The suggested adoption period was 1~2 years (40, 42.6%). The concept and individuals' domestic circumstances were the key problems affecting the clarity, applicability, and local environmental impact of the guideline. Conclusion: The Korean MRCT guideline was well-developed. Their overall impact on the local environmental impact of MRCTs in Korea was expected to be beneficial, but methods are needed to minimize the negative impacts. The findings of this study can inform the priorities for the future adoption of the guideline in Korea.

Analysis on international financial biometric adoption cases and propose a scheme for korean financial telebiometrics (한국형 금융 바이오 인식 기술 도입을 위한 분석 및 방안연구)

  • Shin, Yong-Nyuo;Chun, Myung Geun
    • Journal of the Korea Institute of Information Security & Cryptology
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    • v.25 no.3
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    • pp.665-672
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    • 2015
  • In this paper, we analyze the international financial biometric adoption cases in smart phones and ATMs and propose a scheme for Korean financial telebiometrics. Regional privacy issues, financial services environment, according to the differences in the direction of government policy introducing biometric aspects were appearing differently. In Korea, due to changes in fin-tech vitalization and outstanding convenience mobile oriented service to the regulatory environment, the introduction of biometric technology is the point that is being actively discussed. In this paper, we propose a scheme for the Korean banking financial sector through the introduction of biometric technology adoption case analysis of each country. Thus, this paper is intended to help that the financial sector makes a precise decision when it is establishes a policy of biometric technology application for electronic financial services.

Adjacent Channel Coexistence of LTE in Unlicensed Spectrum (비면허 대역 LTE 시스템의 인접 대역 간섭 분석)

  • Lim, Su Hwan;Jung, Man Young;Lee, Sang-Wook
    • The Journal of Korean Institute of Communications and Information Sciences
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    • v.40 no.10
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    • pp.1879-1888
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    • 2015
  • This paper evaluates the adjacent channel coexistence issues between LAA(License Assisted Access) system and other system (e.g. Wi-Fi) system in 5 GHz unlicensed spectrum. LAA is a technology to achieve enhanced data rate by aggregating licensed and unlicensed spectrum using CA(Carrier Aggregation). The coexistence study is essential before deploying LTE in unlicensed spectrum to verify the impact of LTE on the existing system such as Wi-Fi including system in throughput and regulatory aspects. This paper evaluates and analyzes the RF requirements of LTE system using interference analysis of coexistence study when operating at adjacent frequency channel of the Wi-Fi system in order to minimize the impact of LTE system into Wi-Fi system.

Regional-Scale Evaluation of Groundwater Susceptibility to Nitrate Contamination Based on Soil Survey Information (토양정보를 이용한 광역 지하수의 질산태 질소 오염 민감도 분포 분석)

  • Han, Gwang-Hyun
    • Korean Journal of Soil Science and Fertilizer
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    • v.42 no.1
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    • pp.37-45
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    • 2009
  • Susceptibility assessment of groundwater contamination is a useful tool for many aspects of regional and local groundwater resources planning and management. It can be used to direct regulatory, monitoring, educational, and policy-making efforts to highly vulnerable areas. In this study, a semi process-based was proposed to evaluate relative susceptibilities to groundwater contamination by nitrate on a regional scale. Numerical simulation based on data from each soil series was done to model water flow within soil profiles that were related to groundwater contamination by nitrate. Relative vulnerability indices for each soil series were produced by manipulation of amount of leaching flux, amount of average water storage in a soil profile, and amount of average water storage change. These indices were designed to convey the trend of leaching flux and to maximize spatial resolution. The resulting vulnerability distribution map was used to locate highly vulnerable sites easily with an appropriate grouping the indices, and was then compared with those from groundwater nitrate concentrations monitored. An excellent agreement was obtained across nitrate concentrations from the highly vulnerable regions and those from the low to stable regions.

Regulatory Aspects of Passenger and Crew Safety: Crash Survivability and the Emergency Brace Position

  • Davies, Jan M.
    • The Korean Journal of Air & Space Law and Policy
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    • v.33 no.2
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    • pp.199-224
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    • 2018
  • Aviation's safety record continues to improve yearly, especially with respect to passenger and crew injuries and deaths. However, although the number of accidents has decreased over the decades, there are still many events, such as landings short of the runway and runway excursions, both of which pose threats to passenger and crew safety. Surviving any kind of aviation accident depends on the physiological threat and stress of the impact(s), the extent to which the physical structure surrounding the passengers and crew remains intact, and the ability of the passengers and crew to be able to escape the wreckage. The one action that both passengers and crew can carry out to help decrease the likelihood of crash-related injury or death is to assume an emergency brace position. Doing so has been demonstrated over several decades to improve survivability. While cabin crew are taught (and then might have to teach passengers in an emergency about the emergency brace position), passengers in many parts of the world never learn about the brace position unless they are involved in an emergency in which there is time to prepare for the landing. This lack of provision of information is related to the fact that most airlines do not provide information in the preflight safety briefing and some do not even provide the information in the passenger safety cards. Many countries do not require their airlines to do so, a fact, which in turn, is related to the lack of mention of the brace position in ICAO's Annex 6. Until standards and recommended practices are changed at the highest world level, passengers will continue to be deprived of this vital, life-saving information that they can use, potentially to help save their own lives.

Analysis of the Recall Demand Pattern of Imported Cars and Application of ARIMA Demand Forecasting Model (수입자동차 리콜 수요패턴 분석과 ARIMA 수요 예측모형의 적용)

  • Jeong, Sangcheon;Park, Sohyun;Kim, Seungchul
    • Journal of Korean Society of Industrial and Systems Engineering
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    • v.43 no.4
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    • pp.93-106
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    • 2020
  • This research explores how imported automobile companies can develop their strategies to improve the outcome of their recalls. For this, the researchers analyzed patterns of recall demand, classified recall types based on the demand patterns and examined response strategies, considering plans on how to procure parts and induce customers to visit workshops, recall execution capacity and costs. As a result, recalls are classified into four types: U-type, reverse U-type, L- type and reverse L-type. Also, as determinants of the types, the following factors are further categorized into four types and 12 sub-types of recalls: the height of maximum demand, which indicates the volatility of recall demand; the number of peaks, which are the patterns of demand variations; and the tail length of the demand curve, which indicates the speed of recalls. The classification resulted in the following: L-type, or customer-driven recall, is the most common type of recalls, taking up 25 out of the total 36 cases, followed by five U-type, four reverse L-type, and two reverse U-type cases. Prior studies show that the types of recalls are determined by factors influencing recall execution rates: severity, the number of cars to be recalled, recall execution rate, government policies, time since model launch, and recall costs, etc. As a component demand forecast model for automobile recalls, this study estimated the ARIMA model. ARIMA models were shown in three models: ARIMA (1,0,0), ARIMA (0,0,1) and ARIMA (0,0,0). These all three ARIMA models appear to be significant for all recall patterns, indicating that the ARIMA model is very valid as a predictive model for car recall patterns. Based on the classification of recall types, we drew some strategic implications for recall response according to types of recalls. The conclusion section of this research suggests the implications for several aspects: how to improve the recall outcome (execution rate), customer satisfaction, brand image, recall costs, and response to the regulatory authority.

A Study on Analysis Criteria for AI Service Impact Assessment (인공지능 서비스 영향성 평가를 위한 분석 기준 연구)

  • Soonduck, Yoo
    • The Journal of the Institute of Internet, Broadcasting and Communication
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    • v.23 no.1
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    • pp.7-13
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    • 2023
  • This study investigated the criteria for evaluating the impact of artificial intelligence services. The study classified AI evaluation targets into two areas: AI service and AI technology, and identified influence, sustainability, efficiency, effectiveness, and appropriateness as potential evaluation criteria. The time aspect of AI service evaluation was divided into pre-evaluation and post-evaluation, with pre-evaluation focused on reviewing items during development and design. The AI service area was classified into public, private, and mixed forms, and the impact assessment was classified as vertical or horizontal. The application of AI services was divided into normative and regulatory aspects, and the purpose of the evaluation could be impact or process evaluation. The subject and field of the AI service could also be used for classification purposes. The results of this study can be used to support the creation of AI service impact policies and countermeasures. However, further research is needed to develop specific indicators based on the criteria identified in this study to evaluate the impact of AI services.

Identification and Expression of Retroviral Envelope Polyprotein in the Dogfish Squalus mitsukurii

  • Kim, Soo Cheol;Sumi, Kanij Rukshana;Choe, Myeong Rak;Kho, Kang Hee
    • Journal of Marine Life Science
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    • v.1 no.2
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    • pp.88-94
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    • 2016
  • Determining the infection history of living organisms is essential for understanding the evolution of infection agents with their host, particularly for key aspects such as immunity. Viruses, which can spread between individuals and often cause disease, have been widely examined. The increasing availability of fish genome sequences has provided specific insights into the diversity and host distribution of retroviruses in fish. The shortspine spurdog (Squalus mitsukurii) is an important elasmobranch species; this medium-sized dogfish typically lives at depths of 100~500 m. However, the retroviral envelope polyprotein in dogfish has not been examined. Thus, the aim of the present study was to identify and analyze the retroviral envelope polyprotein in various tissues of dogfish. The 1334-base pair full-length novel cDNA of dogfish envelope polyprotein (dEnv) was obtained by 3' and 5'-rapid amplification of cDNA end analysis from S. mitsukurii. The open reading frame showed a complete coding sequence of 815 base pairs with a deduced peptide sequence of 183 amino acids that exhibited 34~50% identity with other fish and bird species. It was also expressed according to reverse transcription and real-time polymerase chain reaction in the kidney, liver, intestine, and lung, but not in the gill. This distribution can be assessed by identifying and analyzing endogenous retroviruses in fish, which consists of three main genes: gag, pol and env. Dogfish envelope polyprotein sequence is likely important in evolution and induces rearrangements, altering the regulatory and coding sequences. This is the first report of the identification and molecular characterization of retroviral envelope polyprotein in various tissues of S. mitsukurii.

In Search of Corporate Growth and Scaleup: What Strategies Drive Unicorns and Hyper-Growing Companies?

  • Lee, Young-Dall;Oh, Soyoung
    • 한국벤처창업학회:학술대회논문집
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    • 2021.04a
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    • pp.33-42
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    • 2021
  • Based on the findings of Lee et al.(2020) and Lee & Oh(2021), this paper aims to fill the gap in our knowledge regarding the relationship between strategic choices and corporate growth by utilizing a novel dataset of 'Unicorn' and 'Hyper-growing' companies. Two previous studies provide coherent findings that the relationship between firms' strategies and their performance should be explored under a more comprehensive framework with consideration of both internal and external factors. Therefore, in this study, we apply a single conceptual framework to two different datasets, which considers the strategy factors as independent variables, and the industry(market) and the firm age as moderating variables. For our dependent variables, valuations for unicorn companies and revenue CAGR for hyper-growing companies are used after categorizing them into three uniform groups. The strategy variables include 'Generic (Cost-leadership, Differentiation, focus) strategies', 'Growth(Organic, M&A) strategies', 'Leading(Pioneer, Fast-follower) strategies', 'Target market(B2B, B2C, B2G, C2C) strategies', 'Global(Global, Local) strategies', 'Digital(Online, Offline) strategies.' For industry(market) factors, it consists of historical growth rate for industries and economic, demographic, and regulatory aspects of states and countries. To overcome the differences in their units, they are also uniformly categorized into multiple groups. Before we conduct a regression analysis, we analyze the industry distribution of the 'Unicorn' and the 'Hyper-growing' companies with descriptive statistics at the integrated and individual levels. Next, we employ hierarchical regression models on Study A('Unicorn' companies in 2019) and Study B('Hyper-growing' companies in 2019) under the same comprehensive framework. We then analyze the relationship between the 'strategy' and the 'performance' factors with two different approaches: 1) an integrated regression model with both the sample of Study A and B and 2) respective regression models on Study A and B. This empirical study aims to provide a complete understanding and a reference to which strategy factors should be considered to promote firms' scale-up and growth.

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A Study of Health and Safety Management Practices of Contractors in Southern Vietnam

  • Phung, Van Manh;Manu, Patrick;Mahamadu, Abdul Majeed
    • International conference on construction engineering and project management
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    • 2015.10a
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    • pp.127-131
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    • 2015
  • In spite of the socio-economic benefits of the construction industry, it accounts for many deaths, injuries and illnesses in many countries. In developing countries like Vietnam, the situation is even worse. Health and safety (H&S) management plays a crucial role in the efforts to improve H&S performance as it contributes to mitigating the risks of occupational injuries and illnesses. However, within the wider H&S literature in Vietnam, there is no insight into the current state of affairs of H&S management, particularly in terms of the management practices that need attention in order to improve H&S management across the construction sector. This study therefore presents the findings of an inquiry into the H&S management practices of contractors in Vietnam. The study employed a questionnaire survey which yielded 58 responses from contractors, particularly those operating in Southern Vietnam. Some commonly implemented H&S management practices by the contractors are: provision of personal protective equipment (94%), allocation of H&S supervisor on site (90%), and displaying of company H&S policy on construction sites, company website, and head/branch offices (86%). Some of the less implemented practices are: networking/engaging with other companies/institutions (e.g. government offices) about H&S issues (39%), rewarding workers for safe work behaviour (39%), reviewing and updating H&S plans (48%), and displaying regulatory H&S posters on site (45%). The findings have provided some insight into the current state of affairs of the H&S management practices of contractors in Southern Vietnam and could thus inform efforts by industry stakeholders to improve the aspects of H&S management that are lagging.

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