• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2015.05a
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• pp.781-782
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• 2015

As growth engines such as cloud, social networks, big data that can affect the security market have been grown, the information security industry has has also rapidly evolved. Reviewing information security policies carried out in USA, UK and Japan, this paper examines trends on the IoT-related information protection law and regulations that are at issue around the major developed countries. Through this research, we can get the implication that measures be taken as soon as possible to apply the existing data protection laws in the Internet of Things.

• Korean journal of communication and information
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• v.55
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• pp.74-99
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• 2011

This article tries to find out some regulatory facts to improve and vitalize roles of social media such as facebook, twitter, etc in the election campaign. For this goal, a theoretical approach is based on the agnostic and open aspects of the regulation system of election. Case study and in-depth interview were used as research methods in this article. The results are as follows. First, some differences are in the election regulatory system regarding the roles of social media in UK, US, Japan and Korea. The election public sphere systems of these countries categorized to the types of legal factors to control political communications in election public sphere; free-speech oriented system(UK. US), limited free-speech oriented system(Korea), normative-oriented system(Japan). Second, most respondents answered they agreed with some improvement ideas to reflect needs of netizen and academic who suggest to minimize regulatory burdens on social media in the political communication during the election campaign.

• 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.

• Journal of Service Research and Studies
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• v.4 no.2
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• pp.57-67
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• 2014

Because telemedicine is also the medical care, it is limited by law to allow medical personnel only physician because there would cause a risk to health and hygiene. Since the work dealing with the life and honor the human body involving a small mistake, it may be difficult to recover the damages can be recovered even if the telemedicine. Therefore, systematically it is to allow remote medical care only proven national healthcare only clinical practice starting with basic medical medicine, and received training as a systematic study of the body and life of humans. The patient information could get far away in the distance to provide medical information and professional advice to the remote system, even if you can not be reached due to several issues such as the number of differences that occur in time. We Mentioned various opinions on regulatory issues and information gathered for the development of the medical industry in this respect.

• The Journal of Asian Finance, Economics and Business
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• v.7 no.7
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• pp.349-360
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• 2020

The study aims to empirically examine the determinants of bank margins from Pakistan, an emerging South Asian economy. To elucidate the importance of the Pakistani banking sector, secondary data has been used, which was extracted from the annual accounts of twenty-four Pakistani scheduled commercial banks (20 conventional, four full-fledged Islamic) over a sample period of 2006 to 2017. The factors identified in the dealership model and the subsequent empirical developments in the dealership model categorized as bank-specific, diversification, regulatory, and industry concentration are analyzed by applying the most-common linear dynamic panel-data estimator, the Generalized Method of Moments (GMM) estimator, developed by Arellano and Bond (1991). The findings reveal that, among the bank-specific variables, funding cost, credit risk, managerial efficiency, market share, and operating cost are significant predictors of bank margins. For diversification variables employed in the study, both variables including net non-interest income and asset diversity are as well significant predictors of bank margins. It is also found that the market concentration variable proxied by the Herfindahl-Hirschman Index (HHI) is significantly predicting bank margins. Subsequently, one of the regulatory variables, the opportunity cost of holding reserves, and one bank-specific variable, the degree of risk aversion, are insignificant in the model.

• Information Systems Review
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• v.22 no.4
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• pp.135-161
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• 2020

With the growth of blockchain and cryptocurrency-related markets, cryptocurrency exchanges are growing as a new industry. However, as the legal and regulatory definitions of cryptocurrencies are still in progress, unlike existing industrial groups, they are not under the supervision of regulatory agencies. As a result, users (i.e., cryptocurrency investors) have suffered two types of damage that could occur from hacking and other accidents on the exchanges. One type of the damage is the loss of assets caused by the extortion of personal information or account and the other is the damage from users who might be involved in external frauds. Both are analyzed in comparison with existing operators whose functions are like the exchanges. The results of this study show that membership (KYC: Know Your Client), log-in, and additional authentication in transactions are on the similar level to those of the operators while the fraud detection system (FDS) and anti-money laundering (AML) of fiat currencies and cryptocurrencies need rapid improvement.

• Asia Marketing Journal
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• v.13 no.3
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• pp.209-231
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• 2011

Internet is having strong impact on the consumer's decision making process. Information search has been done actively through internet today. The online reviews can be crucial information cue to evaluate the alternarive products. The online WOM(Word-Of-Mouth) effect depends on the characteristics of information sender, receiver, and WOM. This study is to examine the influence of the online word of mouth on the consumer purchase intention and the moderating role of product involvement, consumer regulatory focus and self-efficacy. Positive customer reviews on the products influence the purchase intention positively and negative customer reviews influence it negatively. Moderating role of involvement in the causal relation between the valence of online reviews and purchase intention is tested. In case of positive WOM, it is predicted that purchase intention for high involvement products is higher than that of low involvement. In case of negative WOM, purchase intention for high involvement product is lower than that of low involvement product. And this study invetigate the moderating role of regulatory focus. In case of positive WOM, it is predicted that promotion focus oriented consumers have higher purchase intention than prevention focus oriented consumers. In case of negative WOM, prediction is that prevention focus oriented consumers have lower purchase intention than promotion focus oriented consumers. Then we examine the moderating role of self efficacy in the causal relation between the valence of online reviews and purchase intention. In case of positive WOM, it is predicted that consumers with low self efficacy have higher purchase intention than consumers with high self efficacy. In case of negative WOM, it is predicted that consumers with low self efficacy have lower purchase intention than consumers with high self efficacy. Emprical results support our prediction and four hypotheses derived from our conceptual framework are all accepted. This study suggest that the level of product involvement, consumer regulatory focus and the level of self-efficacy influence the consumer responses of the valence of online reviews. Therefore marketers need to manage online reviews based on the level of product involvement, regulatory focus orientation and the level of self-efficacy of target consumers.

• 대한예방의학회:학술대회논문집
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• 1994.02a
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• pp.450-468
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• 1994

Scientists have long used conventional toxicological methods to establish 'safe levels of exposure' for chemicals presumed to have threshold health effects or doses below which significant effects are unlikely to occur. These same methods cannot be used to establish safe levels of exposure for non-threshold pollutants. such as carcinogens. Therefore. Federal regulatory agencies in the United States are using risk assessment methods to provide information for public health policy decisions concerning increases in risk associated with increases in exposure to carcinogenic and other non-threshold pollutants. Acceptable exposure/risk levels are decided by policymakers who consider descriptions and estimates of risks together with social and economic benefits from the uses of the chemical. 1bis paper focuses on the development of quantitative risk assessment approaches by Federal regulatory agencies in the United States, and identifies the mathematical models currently being used for risk extrapolation. including their inherent uncertainties. The uncertainties and limitations of these methods have led some scientists to question the utility of quantitative risk extrapolation. The experience of the; U.S. Environmental Protection Agency (EPA). as summarized in this paper. can provide a realistic basis for evaluating the pros and cons. Finally. shortcomings in current risk assessment methods and their use in policy decisions are explored. and areas for possible improvement. given current scientific knowledge. are identified.

• Proceedings of the Korean Society for Bioinformatics Conference
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• 2003.10a
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• pp.164-169
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• 2003

In this paper, we propose the integrated Bayesian network framework to reconstruct genetic regulatory networks from genome expression data. The proposed model overcomes the dimensionality problem of multivariate analysis by building coherent sub-networks from confined gene clusters and combining these networks via intermediary points. Gene Shaving algorithm is used to cluster genes that share a common function or co-regulation. Retrieved clusters incorporate prior biological knowledge such as Gene Ontology, pathway, and protein protein interaction information for extracting other related genes. With these extended gene list, system builds genetic sub-networks using Bayesian network with MDL score and Sparse Candidate algorithm. Identifying functional modules of genes is done by not only microarray data itself but also well-proved biological knowledge. This integrated approach can improve there liability of a network in that false relations due to the lack of data can be reduced. Another advantage is the decreased computational complexity by constrained gene sets. To evaluate the proposed system, S. Cerevisiae cell cycle data [1] is applied. The result analysis presents new hypotheses about novel genetic interactions as well as typical relationships known by previous researches [2].