• Korean journal of communication and information
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• v.27
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• pp.213-245
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• 2004

As we know, broadcasting implies a unilateral transmission by one sender to several recipients of information generally produced by third parties. Contrary to that, telecommunications implies an exchange between participants. Participants exchange information they produce during an interaction. However, in the age of convergence between telecommunication and broadcasting, it becomes difficult to determine exactly the boundary between services classified under telecommunications and those classified under broadcasting services. This means that new regulatory regime should be introduced to meet the convergence between telecommunication and broadcasting. In this article, we try to overcome the existing framework for understanding and regulating convergent services. In order to develop more powerful and useful framework for dealing with new convergent services, we focus on the original characteristic of "cast services," which could give us very significant basis for further discussion. "Cast services," such as traditional broadcasting services, have the characteristics of both public goods (non-exclusivity and non-rivalry in consumption) and non-interactivity. Depending on the existence of these three characteristics, we are able to apply different regulatory regime to those convergent services.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.315-346
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• 2016

With the development of big data processing technology, the potential value of healthcare big data has attracted much attention. In order to realize these potential values, various research using the healthcare big data are essential. However, the big data regulatory system centered on the Personal Information Protection Act does not take into account the aspect of big data as an economic material and causes many obstacles to utilize it as a research purpose. The regulatory system of healthcare information, centered on the primary purpose of patient treatment, should be improved in a way that is compatible with the development of technology and easy to use for public interest. To this end, it is necessary to examine the trends of overseas legal system reflecting the concerns about the balance of protection and utilization of personal information. Based on the implications of the overseas legal system, we can derive improvement points in the following directions from our legal system. First, a legal system that specializes in healthcare information and encompasses protection and utilization is needed. De-identification, which is an exception to the Privacy Act, should also clearly define its level. It is necessary to establish a legal basis for linking healthcare big data to create synergy effects in research. It is also necessary to examine the introduction of the opt-out system on the basis of the discussion on the foreign debate and social consensus. But most importantly, it is the people's trust in these systems.

• International Commerce and Information Review
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• v.7 no.4
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• pp.157-177
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• 2005

In many countries, a Single Window system for simplifications is establishing in order to reduce works submitted double data and compliance costs. A Single Window is defined as a facility that allows parties involved in trade and transport to lodge standardized information and documents with a single entry point to fulfil all import, export, and transit-related regulatory requirements. A Single window can bring improved level of security, faster clearance and reduced compliance costs. UN/CEFACT released "Recommendation and Guidelines on establishing a Single Window to enhance the efficient exchange of information between trade and government". Also, WCO has made progress several projects to assist effective establishing a single window, i.e. CDM, UCR, ICT. Korea has being established a single window system, "e-trade platform" connected with trade, clearance, logistics, marketing and payment system. Some suggestions to establish a effective single window system in Korea are as follows. Firstly, it is necessary to clearly define roles and responsibilities of a lead agency in a single window system and form a organic relationship with PGA. Secondly, a single window system has to be progressed by stages, namely, customs clearance portal system should be established first, and later established e-trade platform. Lastly, the Korean government has to take part in CDM project to gain an advantage over other countries.

• Proceedings of the Korean Society of Computer Information Conference
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• 2014.01a
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• pp.429-432
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• 2014

국내 제약산업의 경쟁력을 제고시키기 위해서는 신약의 심사/허가 기간을 단축시켜 급변하게 변하는 글로벌 제약시장에서 경쟁 우위적 위치를 선점할 수 있도록 기회를 제공할 수 있도록 체계 개선이 시급하다. 신약허가를 위해서는 임상시험 결과에 대한 안전성과 유효성 등에 대한 심사가 수행되게 된다. 하지만 현재 신약허가를 위해서 제약사와 임상시험수탁기관(Contract Research Organization, CRO)에서 데이터 정보체계인 Domain, Variable 및 Parameter 등의 표준을 따르지 않고 다양한 유형의 임상정보데이터를 심사기관에 제출하고 있어 이로 인한 심사기간 증가와 심사업무 비효율성을 야기시키고 있다. 따라서 본 연구에서는 국제민간기구인 CDISC (Clinical Data Interchange Standards Consortium)에서 제정한 글로벌 임상데이터 표준인 CDISC 표준을 준용한 국내 임상시험정보관리 체계 (eCTD 시스템)및 의약품 전주기적 관리체계를 제시하고자 하며, 본 연구를 통한 기대효과로는 국제표준의 임상정보관리 인프라 구축으로 인한 국내 신약개발 및 해외 진출 환경을 마련하여 글로벌 시장선점의 기회를 제공할 수 있고, 규제기관 차원에서는 의약품 허가, 심사업무의 효율성 증가는 물론 전주기적 의약품 안전관리체계를 마련할 수 있을 것으로 사료된다.

• International Journal of Advanced Culture Technology
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• v.7 no.2
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• pp.7-12
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• 2019

Korea's laws regarding ICT must follow the Void for vagueness doctrine, the Principle of forbidden general delegation, the Principle of justification of system and the Principle of balancing test in the Constitution. The Act for the Promotion and Convergence and so on of Information and Communication in the Future should be improved as follows. It is desirable to improve the part where the principle of system justification of the Constitution is problematic in relation to existing laws. It is desirable to improve the ICT's policies on industry and convergence technologies so that they are well balanced between promotion and regulation of ICT's industries. It is desirable to improve the information service policy and legislative makeup relationship between various government agencies related to ICT. It is therefore desirable to improve the institutional complement to the post-regulatory framework for the protection of users of ICT in the future. It is desirable to create a device to replace the functions of the Information Service Budget Council in the special law of ICT.

• Korean journal of communication and information
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• v.58
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• pp.106-129
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• 2012

Social Network Service(SNS), which are an emerging form of political architecture, have been a political means to promote civic engagement and shape pubic opinions on social issues. Along with the influence of SNSs, the governmental control on the dissemination of information over SNSs has increased more and more. It would be ideal if the autonomous governance regulates SNSs which facilitate the networks of the dispersed people. It is the fact, though, that compulsory regulations under which the government controls impose policy and legal restrictions on political expressions. The current study addresses expressive and participatory nature embedded in technological characteristics of SNSs and discusses the problems of content regulations of political expression over SNSs. First of all, it is analyzed that light touch regulation or light touch monitoring should be applied to regulating content on SNSs, particularly political expressions. Constitutional Court proclaimed that legal restrictions on the Internet could infringe basic rights of the people and thus under unambiguous standards, the Doctrine of Clear and Present Danger should be applied to its content. Second, it is found that clarifying the definition of illegality in the application of legal restrictions is necessary to minimize the excessive misleading. Third, it is required that Korea Communications Standards Commission under the government control needs to change in determining the scope of illegal information. In a domestic level, there needs to be safeguards for the protection of the self-regulatory organization such as KISO to guarantee voluntary and autonomous regulatory practices.

• Journal of Distribution Science
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• v.14 no.3
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• pp.85-91
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• 2016

Purpose - Prior research has suggested that consumers typically prefer to have a larger number of options. However, preference of assortment size may depend on how depleted resources in consumers' mind are. Reduced capacity for self-regulation by resource depletion makes people rely on more intuitive and less effortful decision processing. When they are mentally depleted, people are likely to focus on the choice difficulty from large assortment, which leads to preference for the small assortment when they make a decision. It could be an important question potentially how being in a depleted mode through effortful self-regulation will influence on the evaluation of assortment size. To answer this questioner, we hypothesized that being engaged in self-regulation, as compared with not being engaged in self-regulation, will influence on the evaluation of product assortment size such as attractiveness, difficulty of choice, and anticipated regret. Research design, data, and methodology - In this study, we first manipulated self-regulatory resource availability using a self-regulation task (i.e., instructing participants to solve Sudoku puzzle vs. to solve diagram cube by filling any diagrams that they prefer into cube instead of number) and asked to indicate the difficulty of the tasks available to them ("How much difficulty did you feel when you complete the task?") Next, participants were asked to imagine that they were planning to buy a laptop at one of the two stores (small assortment: 6 options vs. large assortment: 30 options), both offering good quality of products. After reading the product descriptions, participants were instructed to consider all the information and choose a store that they would like to shop. Finally we measured the choice difficulty, evaluation of product assortments, and anticipated regret on a 7-point scale. We conducted two-way ANOVA in testing the main hypothesis that depleted consumers will show poorer subsequent self-control than non-depleted consumers when they make a decision in large assortment. Results - Compared with non-depleted participants, depleted participants showed the bigger difference from the degree of choice difficulty and product attractiveness between large and small assortments, but the result revealed only a significant interaction effect of resource depletion and assortment size on choice difficulty. Also depleted participants showed the smaller difference from the degree of anticipated regret between large and small assortments than non-depleted participants. Conclusion - Depleted individuals by a prior task are relatively effortless and intuitive form of choosing products so that they try to avoid making effortful trade-offs among choice difficulty such as large assortment, compare with non-depleted individuals. However, for anticipated regret, non-depleted individuals in small assortment anticipate more regret by excluding or at least restricting the possibility of buying attractive items or another kind of potential items than depleted individuals, regardless less choice difficulty in small option. To sum up, it is important to note that individuals are influenced by self-regulatory resources and their self-regulatory conditions contribute to the overall positive or negative impact of product assortment on choice.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.146-153
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• 2018

Objective: Multi-regional clinical trials have been widely used for accelerating global drug development by multinational pharmaceutical companies. In this study, we aimed to review and analyze the international trends in regulations and guidelines on multi-regional clinical trials by regulatory authorities and international organizations, such as International Conference on Harmonisation, for referring to policies, including development of domestic guidelines for multi-regional clinical trials. Methods: The policies, regulations, and guidelines published by the US Food and Drug Administration, European Medicines Agency, Pharmaceuticals and Medical Devices Agency (Japan), and China Food and Drug Administration were searched, and the International Conference on Harmonisation E17 draft guideline was reviewed. Results: The regulatory authorities in developed countries have developed and implemented regulations and guidelines on multi-regional clinical trials to promote simultaneous global drug development and evaluate the regional differences in drug safety and efficacy. International Conference on Harmonisation developed the draft guideline for planning/designing of multi-regional clinical trials in 2016, which recommends the general principles for strategy-related issues and design of multi-regional clinical trials, and for protocol-related issues, such as consideration of regional variability, subject selection, dose selection, endpoints, comparators, overall sample size, allocation to regions, collecting information on efficacy and safety, and statistical analysis. Conclusion: It is important to understand the international regulatory requirements for designing and planning of multi-regional clinical trials for global drug development. Moreover, it is necessary to prepare multi-regional clinical trial guidelines in accordance with the Korean regulation for clinical trials and drug administration.

• Journal of Environmental Health Sciences
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• v.47 no.5
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• pp.432-445
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• 2021

Background: The European Centre for Ecotoxicology and Toxicology of Chemicals' Targeted Risk Assessment (ECETOC TRA) tool has been recognized by EU REACH as a preferred approach for calculating worker health risks from chemicals. Objectives: The applicability of the ECETOC TRA to occupational exposure estimation from industrial uses of methanol was studied by inputting surveyed and varied parameters for TRA estimation as well as through comparison with measured data. Methods: Information on uses of methanol was collected from seven working environment monitoring reports along with the measured exposure data. Input parameters for TRA estimation such as operating conditions (OCs), risk management measures (RMMs) and process categories (PROCs) were surveyed. To compare with measured exposures, parameters from the surveyed conditions of ventilation but no use of respiratory protection were applied. Results: PROCs 4, 5, 8a, 10, and 15 were assigned to ten uses of methanol. The uses include as a solvent for manufacturing sun cream, surfactants, dyestuffs, films and adhesives. Methanol was also used as a component in a release agent, hardening media and mold wash for cast products as well as a component of hard-coating solution and a viscosity-controlling agent for manufacturing glass lenses. PROC 8a and PROC 10 of a cast product manufacturer without LEV (local exhaust ventilation) and general ventilation as well as no respiratory protection resulted in the highest exposure to methanol. Assuming the identical worst OCs and RMMs for all uses, exposures from PROC 5, 8a, and 10 were the same and the highest followed by PROC 4 and 15. The estimation resulted in higher exposures in nine uses except one use where measured exposure approximated exposures without RMMs. Conclusions: The role of ECETOC TRA as a conservative exposure assessment tool was confirmed by comparison with measured data. Moreover, it can guide which RMMs should be applied for the safe use of methanol.

• Asian-Australasian Journal of Animal Sciences
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• v.20 no.2
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• pp.184-193
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• 2007

In mammalian ovary, steroidogenic acute regulatory (StAR) protein mediates the true rate-limiting step of transport of cholesterol from outer to inner mitochondrial membrane. Appropriate expression of StAR gene represents an indispensable component of steroidogenesis and its regulation has been found to be species specific. However, limited information is available regarding StAR gene expression during estrous cycle in buffalo ovary. In the present study, expression, localization and hormonal regulation of StAR mRNA were analyzed by semi-quantitative RT-PCR in buffalo ovary and partial cDNA was cloned. Total RNA was isolated from whole follicles of different sizes, granulosa cells from different size follicles and postovulatory structures like corpus luteum and Corpus albicans. Semi-quantitative RT-PCR analyses showed StAR mRNA expression in the postovulatory structure, corpus luteum. No StAR mRNA was detected in total RNA isolated from whole follicles of different size including the preovulatory follicle (>9 mm in diameter). However, granulosa cells isolated from preovulatory follicles showed the moderate expression of StAR mRNA. To assess the hormonal regulation of StAR mRNA, primary culture of buffalo granulosa cells were treated with FSH (100 ng/ml) alone or along with IGF-I (100 ng/ml) for 12 to 18 h. The abundance of StAR mRNA increased in cells treated with FSH alone or FSH with IGF-I. However, effect of FSH with IGF-I on mRNA expression was found highly significant (p<0.01). In conclusion, differential expression of StAR messages was observed during estrous cycle in buffalo ovary. Also, there was a synergistic action of IGF-I on FSH stimulation of StAR gene.