• Title/Summary/Keyword: Self-regulatory system

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Development of Regulation System for Off-Label Drug Use (의약품 허가외사용 관리 체계 발전 방안)

  • Lee, Iyn-Hyang;Seo, Mikyeong;Lee, Young Sook;Kye, Seunghee;Kim, Hyunah;Lee, Sukhyang
    • YAKHAK HOEJI
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    • v.58 no.2
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    • pp.112-124
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    • 2014
  • This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

A Study of Cooldown Performance of Shutdown Cooling System of Korea Next Generation Reactor (차세대 원자로 정지냉각계통의 냉각 성능에 대한 연구)

  • 유성연;이상섭
    • Journal of Energy Engineering
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    • v.8 no.4
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    • pp.525-532
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    • 1999
  • The standardized Korea Next Generation Reactor (KNGR) NSSS has developed in the basis of the ABB-CE System 80+ design concept. In this study, several regulatory requirements for the KNGR shutdown cooling system (SCS) operation are investigated. The purpose of this study is to establish the technical self-reliance for SCS design by supporting fundamental data such as SDCHX effective area and reactor CCW flow rate. Thermal power of KNGR would be increased to about 4,000 $MW_{th}$ in comparison with thermal power 2.825 $MW_{th}$ of UCN 3&4, therefore, SCS design data shall b recalculated by using the KDESCENT Code, which could evaluate cooling capability of SCS. It is found that SCS minimum flow rate is able to remove the primary sensible heat. Reviewing the major components such as heat exchanger, pump, value, and operating procedure, it is concluded as follows.

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A Linkage Analysis of ISMS-P and GDPR; Focused on Personal Information Protection (ISMS-P와 GDPR의 개인정보보호 부문 연계 분석)

  • Park, Minjung;Yu, Jieun;Chai, Sangmi
    • Journal of Information Technology Services
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    • v.18 no.2
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    • pp.55-73
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    • 2019
  • The importance of the personal information has been increased, there have been a lot of efforts to establish a new policy, certification or law for administrating personal information more effectively and safely. Korean government has operated ISMS and PIMS certification system to assess whether an organization has established and managed appropriate information security system or not. However, it has been addressed the needs for revising and modifying of PIMS and ISMS. It is evaluated there are a few overlapped criteria to assess information management system in both ISMS and PIMS. ISMS-P certification, combining with ISMS and PIMS, is, finally, suggested, in the recent. GDPR is established having an aim of primarily to give control to individuals over their personal data and to simplify the regulatory environment for international business by unifying the regulation within the EU. This study compares GDPR and ISMS-P, focusing on "personal information". It can be expected to contribute as followings. This study can be a criterion for self-evaluation of possibility to violate of GDPR of a firm in preparation for ISMS-P. Second, this study also aims to increase the understanding of the role of ISMS-P and GDPR, among various certifications with the purpose of assessment of the information security management system, by reducing the costs required to obtain the unnecessary certification and alleviating the burden. Third, it contributes to diffusion of ISMS-P newly implemented in Korea.

Image based Experience Goods, Text-based Search Goods: Cognitive Fit between Product Information Composition and Product Type depending on Regulatory Focus (이미지 기반의 경험재, 텍스트 기반의 탐색재: 조절초점에 따른 제품 정보 구성 방식과 제품 유형의 일치 효과)

  • Park, Kyung-Hee;Seo, Bong-Goon;Park, Do-Hyung
    • Journal of Intelligence and Information Systems
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    • v.28 no.2
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    • pp.75-100
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    • 2022
  • Untact mobile commerce shows a rapid growth due to the prolonged COVID-19 pandemic. And companies have a lot of tough competition in this trend. However, the detail pages of products which play an important role in purchase decision have been provided mostly for consumers in a form of stereotyped information composition. This study has found that the form of (image-centered vs. text-centered) information composition of detailed descriptions of products in the detail pages of mobile products has an effect on product attitude and purchase intention as consumers' information appeal methods vary depending on product types (search goods vs. experience goods). That is, search goods whose information search is easy and whose quality is predictable could be found that product attitude and purchase intention have a more positive effect on the form of image-centered information composition. And experience goods whose quality is unpredictable could be found that product attitude and purchase intention have a more positive effect on the form of text-centered information composition. And effects of congruence between product types based on Higgins' regulatory focus theory and the form of information composition have found to vary depending on consumers' chronic regulatory focus. Promotion focus seeking consumers showed effects of congruence between product types and the form of information composition and prevention focus seeking consumers did not show effects of congruence between them. That is, promotion focus seeking consumers have found to have more positive product attitude and purchase intention in the form of image-centered information composition of experience goods and text-centered information composition of search goods. And prevention focus seeking consumers have found to be unable to have an effect on product attitude and purchase intention even though the form of image or text-centered information composition of search and experience goods is presented. The study implies that the form of information composition should be designed, produced, and provided for consumers by considering product types and consumer propensity when designing it in the detail pages of mobile products.

Syphacia obvelata: A New Hope to Induction of Intestinal Immunological Tolerance in C57BL/6 Mice

  • Taghipour, Niloofar;Mosaffa, Nariman;Rostami-Nejad, Mohammad;Homayoni, Mohamad Mohsen;Mortaz, Esmaeil;Aghdaei, Hamid Asadzadeh;Zali, Mohammad Reza
    • Parasites, Hosts and Diseases
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    • v.55 no.4
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    • pp.439-444
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    • 2017
  • The ability of nematodes to manipulate the immune system of their host towards a Th2 and T regulatory responses has been proposed to suppress the inflammatory response. Clinical trials have proposed a useful effect of helminth infections on improvement of inflammatory disorders. In this study, we investigated the immunomodulatory effect of Syphacia obvelata infection to induce intestinal tolerance in C57BL/6 mice. Mice were infected through the cagemates with self-infected BALB/c mice. Four weeks post-infection, expression levels of $IFN-{\gamma}$, $TNF-{\alpha}$, IL-17, and IL-10 were assessed in the supernatant of mesenteric lymph node (MLN) culture. $Foxp3^+Treg$ were measured in MLN cells by flow cytometry. In the S. obvelata-infected group, the percentage of Tregs ($5.2{\pm}0.4$) was significantly higher than the control ($3.6{\pm}0.5$) (P<0.05). The levels of IL-10 ($55.3{\pm}2.2$ vs $35.2{\pm}3.2$), IL-17 ($52.9{\pm}3.8$ vs $41{\pm}1.8$), $IFN-{\gamma}$ ($44.8{\pm}4.8$ vs $22.3{\pm}2.3$) and $TNF-{\alpha}$ ($71.1{\pm}5.8$ vs $60.1{\pm}3.3$) were significantly increased in infected mice compared to the control group (P<0.05). The above results showed the potential effects of S. obvelata to induce intestinal tolerance. Therefore, it seems that S. obvelata may increase the immunological suppressive function in the intestinal tract.

International Monetary System Reform and the G20 (국제통화제도의 개혁과 G20)

  • Cho, Yoon Je
    • KDI Journal of Economic Policy
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    • v.32 no.4
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    • pp.153-195
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    • 2010
  • The recent global financial crisis has been the outcome of, among other things, the mismatch between institutions and the reality of the market in the current global financial system. The International financial institutions (IFIs) that were designed more than 60 years ago can no longer effectively meet the challenges posed by the current global economy. While the global financial market has become integrated like a single market, there is no international lender of last resort or global regulatory body. There also has been a rapid shift in the weight of economic power. The share of the Group of 7 (G7) countries in global gross domestic product (GDP) fell and the share of emerging market economies increased rapidly. Therefore, the tasks facing us today are: (i) to reform the IFIs -mandate, resources, management, and governance structure; (ii) to reform the system such as the international monetary system (IMS), and regulatory framework of the global financial system; and (iii) to reform global economic governance. The main focus of this paper will be the IMS reform and the role of the Group of Twenty (G20) summit meetings. The current IMS problems can be summarized as follows. First, the demand for foreign reserve accumulation has been increasing despite the movement from fixed exchange rate regimes to floating rate regimes some 40 years ago. Second, this increasing demand for foreign reserves has been concentrated in US dollar assets, especially public securities. Third, as the IMS relies too heavily on the supply of currency issued by a center country (the US), it gives an exorbitant privilege to this country, which can issue Treasury bills at the lowest possible interest rate in the international capital market. Fourth, as a related problem, the global financial system depends too heavily on the center country's ability to maintain the stability of the value of its currency and strength of its own financial system. Fifth, international capital flows have been distorted in the current IMS, from EMEs and developing countries where the productivity of capital investment is higher, to advanced economies, especially the US, where the return to capital investment is lower. Given these problems, there have been various proposals to reform the current IMS. They can be grouped into two: demand-side and supply-side reform. The key in the former is how to reduce the widespread strong demand for foreign reserve holdings among EMEs. There have been several proposals to reduce the self-insurance motivation. They include third-party insurance and the expansion of the opportunity to borrow from a global and regional reserve pool, or access to global lender of last resort (or something similar). However, the first option would be too costly. That leads us to the second option - building a stronger globalfinancial safety net. Discussions on supply-side reform of the IMS focus on how to diversify the supply of international reserve currency. The proposals include moving to a multiple currency system; increased allocation and wider use of special drawing rights (SDR); and creating a new global reserve currency. A key question is whether diversification should be encouraged among suitable existing currencies, or if it should be sought more with global reserve assets, acting as a complement or even substitute to existing ones. Each proposal has its pros and cons; they also face trade-offs between desirability and political feasibility. The transition would require close collaboration among the major players. This should include efforts at the least to strengthen policy coordination and collaboration among the major economies, and to reform the IMF to make it a more effective institution for bilateral and multilateral surveillance and as an international lender of last resort. The success on both fronts depends heavily on global economic governance reform and the role of the G20. The challenge is how to make the G20 effective. Without institutional innovations within the G20, there is a high risk that its summits will follow the path of previous summit meetings, such as G7/G8.

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A Study on Developing Qualification Criteria in the Private Security Industry (민간경비 자격검정 개선방안에 관한 연구)

  • Choe, Jung-Taek
    • Korean Security Journal
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    • no.18
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    • pp.143-167
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    • 2009
  • As of entering the 21st century, a trend in the field of a private security industry among the advanced countries have been increased a qualification system and train session to meet the needs of professionalism. Intensifying the professionalism in Korea, education and train system has been initiated to change but the oligopoly market already formulated due to impractical selection standard and management of education system. Issuing certification and offering basic training through a designated institution for the purpose of improving quality of the private security industry worker, its practical effectiveness were lower than expectation. Rather certification-holder or security agency, institution or truster's rent-seeking behavior have been increased by occupational licensing system. The founded results, which were associated to problems in selecting and educating to the private security guard, in this study were that any verification has been initiated towards dual-system in official approval and structural problems in education system, and non-existence of verification for professionalism and management capability to security agency owner and its upper managerial level. Current a dual system in an officially authorized verification system and completion of security guard credential requested change to an unified official qualification verification system to solve those problems. Ranges of an applicant to the unified official qualification verification system should be extend to the whole population in the private security industry. Moreover, minimization of the dead-weigh loss, which is caused by oligopoly phenomenon while using its market-dominant status, increasement number of designated institution, which allows self-regulating competition, and endowment of autonomy, which is in selecting education and agency, were requested to solve the problems in selecting and educating to the private security guard. In order to minimize stated problems while maintaining objectiveness, a new manage and supervise institution, which is called a 'private security industry committee', should be establish. The private security industry committee is a formation of governance network which are participated from professional group to civil organization.

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The Role of Tolerance to Promote the Improving the Quality of Training the Specialists in the Information Society

  • Oleksandr, Makarenko;Inna, Levenok;Valentyna, Shakhrai;Liudmyla, Koval;Tetiana, Tyulpa;Andrii, Shevchuk;Olena, Bida
    • International Journal of Computer Science & Network Security
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    • v.22 no.12
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    • pp.63-70
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    • 2022
  • The essence of the definition of "tolerance" is analyzed. Motivational, knowledge and behavioral criteria for tolerance of future teachers are highlighted. Indicators of the motivational criterion are the formation of value orientations, motivational orientation, and the development of empathy. Originality and productivity of thoughts and judgments, tact of dialogue, pedagogical ethics and tact are confirmed as indicators of the knowledge criterion. The behavioral criterion includes social activity as a life position, emotional and volitional endurance, and self-control of one's own position. The formation of tolerance is influenced by a number of factors: the social environment, the information society, existing stereotypes and ideas in society, the system of education and relationships between people, and the system of values. The main factors that contribute to the education of tolerance in future teachers are highlighted. Analyzing the structure of tolerance, it is necessary to distinguish the following functions of tolerance: - motivational (determines the composition and strength of motivation for social activity and behavior, promotes the development of life experience, because it allows the individual to accept other points of view and vision of the solution; - informational (understanding the situation, the personality of another person); - regulatory (tolerance has a close connection with the strong - willed qualities of a person: endurance, selfcontrol, self-regulation, which were formed in the process of Education); - adaptive (allows the individual to develop in the process of joint activity a positive, emotional, stable attitude to the activity itself, which the individual carries out, to the object and subject of joint relations). The implementation of pedagogical functions in the information society: educational, organizational, predictive, informational, communicative, controlling, etc. provides grounds to consider pedagogical tolerance as an integrative personal quality of a representative of any profession in the field of "person-person". The positions that should become conditions for the formation of tolerance of the future teacher in the information society are listed.

A survey of the use of veterinary anesthetics in Korea

  • Lee, Jae-Won;Lee, Jeong Ik;Cho, Yoon Ju;Lee, Young-Ah;Kim, Jong-In;Hwang, Bo Ram;Kim, Hyung Joon;Jhun, Hyunjhung;Han, Jin Soo
    • Korean Journal of Veterinary Research
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    • v.54 no.2
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    • pp.101-105
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    • 2014
  • This study was conducted to investigate actual conditions associated with veterinary anesthetic drug use in Korea, and to obtain responses from Korean veterinarians and researchers pertaining to the use of anesthetic drugs. To accomplish this, a nationwide survey was issued to veterinarians working at animal hospitals and to researchers in the Korean Association for Laboratory Animal Science (KALAS). A self-administered questionnaire-based survey was then conducted in which respondents were asked questions about actual conditions associated with the use of animal anesthetic drugs. The survey revealed that the distribution and management of animal medicines in Korea was quite vulnerable to misuse or abuse due to a variety of factors. Therefore, a relevant regulatory system should be strictly enforced to protect vulnerable individuals from abuse or misuse.

The Emergence of Green Chemistry: Triple-Helix for Environmental Science in United States (녹색화학의 출현: 미국 환경과학의 삼중나선)

  • Jeon, June
    • Journal of Science and Technology Studies
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    • v.13 no.1
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    • pp.111-143
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    • 2013
  • Green chemistry is a new scientific field which focuses on the design, manufacture, and use of chemical processes that could prevent pollution and at the same time improve yield efficiency. The few who have written on the emergence of green chemistry have not shed light on the political and economic motivations of green chemistry. As a new study of the emergence of green chemistry, this paper focuses on the relationship among the triple helix of academia, industry, and government which has been critical in the emergence of green chemistry. This paper argues that academia, industry and government created a common ground during the emergence of green chemistry under the common goal of sustainable development since its creation in 1991. Green chemists produced the knowledge to improve the synthetic efficiency to prevent pollution, and the chemical industry used green chemistry research to increase the economic profitability of production system. This specific form of alliance was supported and maintained amid a changing national environmental policy toward pollution prevention and a self-regulatory framework.

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