• Title/Summary/Keyword: Regulatory path

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A Comparative Study on the Regulations on Implantable Bioabsorbable Combination Products -Focusing on the U.S., Europe and Korea- (이식형 흡수성 융복합 의료제품 규제 비교 연구 -미국, 유럽, 한국을 중심으로-)

  • Hyeon Jeong Lee;Mi Hye Kim;Ju Eun Seol;Su Dong Kim;Joo Hee Kim
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.414-427
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    • 2023
  • Implantable bioabsorbable combination products undergo inherent degradation and systemic absorption within the physiological environment, thereby streamlining the therapeutic regimen and obviating the imperative for invasive extraction procedures. This inherent property not only enhances patient convenience and therapeutic efficacy but also underpins a paradigm of support characterized by heightened safety parameters. Within the regulatory landscapes of Korea, the United States, and Europe, implantable bioabsorbable combination products are meticulously classified into distinct categories, either as pharmaceutical implants or as implantable medical devices, depending on their primary mode of action. This scholarly investigation systematically examines the regulatory frameworks governing implantable bioabsorbable combination products in South Korea, the United States, and Europe. Notable discrepancies across national jurisdictions emerge concerning regulatory specifics, including terminology, product classification, and product name associated with these products. The conspicuous absence of standardized approval regulations presents a formidable barrier to the commercialization of these advanced medical devices. This academic discourse passionately emphasizes the critical need for formulating and implementing a sophisticated regulatory framework capable of streamlining the product approval process, thereby paving the way for a seamless path to commercializing implantable bioabsorbable combination products.

A Study on the Path-Creative Characteristics of AI Policy (인공지능정책의 경로창조적 특성에 관한 연구 : 신제도주의의 경로 변화 이론을 기반으로)

  • Jung, Sung Young;Koh, Soon Ju
    • Journal of Information Technology Services
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    • v.20 no.1
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    • pp.93-115
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    • 2021
  • Various policy declarations and institutional experiments involving artificial intelligence are being made in most countries. Depending on how the artificial intelligence policy changes, the role of the government, the scope of the policy, and the policy means used may vary, which can lead to the success or failure of the policy. This study proposed a perspective on AI(Artificial Intelligence) in policy research, investigated the theory of path change, and derived the characteristics of path change in AI policy. Since AI policy is related to a wide range of policy areas and the policy making is at the start points, this study is based on the neo-institutional path theory about the types of institutional changes. As a result of this study, AI policy showed the characteristics of path creation, and in detail presented the conflict relationship between institutional design elements, the scalability of policy areas, policy stratification and policy mix, the top policy characteristics transcending the law, and the experiment for regulatory innovation. Since AI can also be used as a key tool for policy innovation in the future, research on the path and characteristics of AI policy will provide a new direction and approach to government policy or institutional innovation seeking digital transformation.

UniPath: A Knowledge Representation System for Biopathways (바이오패스웨이를 위한 지식 표현 시스템)

  • 이민수;박승수;강성희
    • Journal of KIISE:Software and Applications
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    • v.31 no.3
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    • pp.343-352
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    • 2004
  • Recently, the information processing of ever increasing bio-related data is becoming a very important issue. One of the main sources of these bio-data comes with the form of biopathways, which includes molecular transactions and processes that are part of biochemical systems. The information represented by biopathways includes various organic relations among its components. However, most of the current systems to represent biopathways have been initially developed without computer processing in mind, and hence suffer from inconsistencies and ambiguities. In this paper, we propose an improved notation, called UniPath, for clear and systematic representation of biopathways. The proposed system is designed to provide a unified representation of metabolic and regulatory pathways. We also designed and implemented a graphic editor for UniPath to draw biopathwavs map according to the proposed notation. The graphic editor is designed so that biopathway data can be easily transformed into XML format.

The Effect of Ethical Leadership on Leader Identification, Regulatory Focus, and Task Performance (윤리적 리더십이 리더동일시, 조절초점 및 업무성과에 미치는 영향에 관한 연구)

  • Ryou, Ki-Dong;Kim, Jeong-Sik
    • The Journal of the Korea Contents Association
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    • v.18 no.1
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    • pp.607-622
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    • 2018
  • In this study, we investigated path that influence task performance through mediation of leader identification, regulatory focus (promotion focus and prevention focus). The results of this study are summarized as follows. First, ethical leadership has a positive effect on leader identification. Second, leader identification has played a crucial role in the relationship between ethical leadership and regulatory focus, and regulatory focus also have an important mediating effect on the relationship between leader identification and task performance. These results show that leader identification, regulatory focus play as an important mediator in relationship between ethical leadership and task performance.

The Effect of Evaluation for Participation in Fashion Brand CSR on Brand Identification and Perceived Purchase Value According to Regulatory Focus (사회적 책임활동에 대한 참여평가가 브랜드 동일시 및 구매가치지각에 미치는 영향과 조절초점의 조절효과)

  • Yoon, Nam-Hee;Choi, Mi-Young
    • Journal of the Korean Society of Clothing and Textiles
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    • v.34 no.9
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    • pp.1515-1526
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    • 2010
  • Consumer expectations for ethical businesses have become increasingly high in recent years; the fashion industry is working to implement greater corporate social responsibility (CSR). This study establishes the effects of the evaluation for participation in fashion brand CSR on perceived purchase values. In particular, the process for the evaluation for participation that affect the perceived purchase value through consumer-brand identifications (personal/social) was verified and how the consumer regulatory focuses would influence this process was identified. For this study, an on-line survey was conducted that included a series of filtering questions that measured the level of social concern of respondents. Valid data from 505 female consumers were analyzed for the structure equation modeling. The empirical results suggested that the evaluation for participation in fashion brand CSR positively affected the two dimensions of consumer-brand identification; personal identification and social identification. In addition, consumer-brand identification played a role as a mediating variable in the path to influence the perceived purchase values of CSR brands. Lastly, there were differences in reactions to CSR activities by consumer groups with different regulatory focuses. The effect of the evaluation for participation in fashion brand CSR was shown to be higher for consumers with promotion focuses than on consumers with prevention focuses. The results of this study will help fashion companies understand the importance of the consumer participation in CSR by having consumers participate in ethical consumption.

Workflow Interruptions and Failed Action Regulation in Surgery Personnel

  • Elfering, Achim;Nutzi, Marina;Koch, Patricia;Baur, Heiner
    • Safety and Health at Work
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    • v.5 no.1
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    • pp.1-6
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    • 2014
  • Background: Workflow interruptions during surgery may cause a threat to patient's safety. Workflow interruptions were tested to predict failure in action regulation that in turn predicts near-accidents in surgery and related health care. Methods: One-hundred-and-thirty-three theater nurses and physicians from eight Swiss hospitals participated in a cross-sectional questionnaire survey. The study participation rate was 43%. Results: Structural equation modeling confirmed an indirect path from workflow interruptions through cognitive failure in action regulation on near-accidents (p < 0.05). The indirect path was stronger for workflow interruptions by malfunctions and task organizational blockages compared with workflow interruptions that were caused by persons. The indirect path remained meaningful when individual differences in conscientiousness and compliance with safety regulations were controlled. Conclusion: Task interruptions caused by malfunction and organizational constraints are likely to trigger errors in surgery. Work redesign is recommended to reduce workflow interruptions by malfunction and regulatory constraints.

A Review of Measuring Sensors for Reactor Vessel Internals Comprehensive Vibration Assessment Program in Advanced Power Reactor 1400 (APR1400 원자로 내부구조물 종합진동평가프로그램용 측정센서 검토)

  • Ko, Do-Young;Lee, Jae-Gon
    • Transactions of the Korean Society for Noise and Vibration Engineering
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    • v.21 no.1
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    • pp.47-55
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    • 2011
  • Reactor vessel internals comprehensive vibration assessment program(RVI CVAP) is one of the necessary tests to ensure the safety of nuclear power plants. RVI CVAP of U.S. nuclear regulatory commission regulatory guide 1.20(U.S. NRC R.G. 1.20) consists of the analysis, measurement and inspection. One of the core technologies of the measurement program for RVI CVAP is to select suitable sensors because the measurement is conducted during the critical path of the construction period of nuclear power plants. Therefore, we analyzed RVI thermal-hydraulic and structure design data of Palo Verde nuclear power plant(U.S.), Yonggwang nuclear power plant(Korea) and APR1400 and researched measuring sensors used in them; moreover, we investigated sensors used for measurement of RVI CVAP for the last 20 years throughout the world. Based on these results, we selected suitable measuring sensors for RVI CVAP in advanced power reactor 1400(APR1400).

Research Trend Analysis of Risk Cost Model for UAM Flight Path Planning (UAM 비행 경로 계획을 위한 위험 비용 모델 연구 동향 분석)

  • Jae-Hyeon Kim;Dong-Min Lee;Myeong-Jin Lee;Yeong-Hoon Choi;Ji-Hun Kwon;Jong-Whoa Na
    • Journal of Advanced Navigation Technology
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    • v.28 no.1
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    • pp.68-76
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    • 2024
  • With the recent rapid growth of the domestic and international unmanned aerial vehicle (UAV) market and the increasing importance of UAV operations in urban centers, such as UAMs, the safety management and regulatory framework for human life and property damage caused by UAV failures has been emphasized. In this study, we conducted a comparative analysis of risk-cost models that evaluate the risk of an operating area for safe UAM flight path planning, and identified the main limitations of each model to derive considerations for future model development. By providing a basic model for improving the safety of UAM operations, this study is expected to make an important contribution to technical improvements and policy decisions in the field of UAM flight path planning.

Regulatory Pathways for Siting and Permitting Offshore Wind Facilities (해상풍력발전시설의 부지 및 허가에 관한 승인절차)

  • Yang, Hyoung-Seon
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.20 no.1
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    • pp.71-77
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    • 2014
  • According to the increasement of demand for energy around globe, the concern degree of advanced countries for ocean energy including offshore wind power becomes excited. In domestic case, the government set up a goal that jumps up to the third ranked powerful nation of offshore wind in the world until 2020 and announced "The plan for 2.5-gigawatt wind farm off the south-west coast by 2019". Also the legal basis was created in order to support development of offshore wind power as 'A law on development, use, supply and promotion for New energy and renewable energy' was established by law. However to promote offshore wind power projects, there are much difficulties that developers should be applied by permitting use of public water surface and regulations of several domestic public institution. Therefore in this paper, we suggested an alternative to promote efficient offshore wind power projects by comparative analysis between domestic and foreign on regulatory pathways for siting and permitting offshore wind facilities.

Factors Influencing Policy to Subsidy Regulatory of Smartphone on Purchase Decision (스마트폰 보조금 규제 정책이 구매결정에 미치는 영향)

  • Nam, Soo-Tai
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2015.10a
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    • pp.136-138
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    • 2015
  • Recently, with the rapid expansion of the mobile phone, such as the high price of the smartphone is being constantly handset subsidies at issue in the social harm caused by excessive competition in the mobile communications market. In this research, we aim to analyze factors influencing of the policy to subsidy regulatory on decision to continue purchasing intention of consumers. Predictor factors were selected the perceived usefulness, the perceived ease of use and the policy to subsidy regulatory on the previous study. Participants of this study be going to 200 mobile users in Busan Gyeongnam and Jeonbuk province in accordance with convenience sampling. IBM SPSS Statistics 19 were employed for descriptive statistics, Smart PLS(partial least squares) was employed for confirmatory factor analysis and path analysis of casual relationship among variables and effect. This study suggests practical and theoretical implications based on the results.

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