• Informatization Policy
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• v.27 no.3
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• pp.3-18
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• 2020

In the growing digitalized world, the European Union implemented the General Data Protection Regulation(GDPR) to establish a comprehensive data protection framework across member states. Given the constitutional roots of GDPR, the EU's regulatory approach is different than other data protection regimes. The new regulation has strengthened individual rights to data protection, but it also introduced several obligations for businesses that collect and process personal data. We review the existing literature on privacy, particularly GDPR, from a policy perspective. The evidence outlines data regulation's effects on competition, innovation, marketing activities, and cross-border data flows. The discussion highlights the tradeoffs between increased regulation of data protection and its effects on the market.

• International Journal of Advanced Culture Technology
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• v.9 no.1
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• pp.28-39
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• 2021

In the new era of IoT, a deeper and richer understanding of consumer characteristics is required to accelerate the acceptance and popularization of different types of smart home services (e.g., hedonic or utilitarian smart home services). In the current research, self-regulation systems are considered one of the consumer characteristics. Therefore, this research examines the role of consumers' regulatory focus (promotion focus vs. prevention focus) in their responses to smart home services, particularly when they are not familiar with the services. Specifically, this research examines whether consumers' attitudes toward utilitarian/hedonic smart home services differ according to their regulatory focus, particularly when they are not familiar with the services. The results indicate that consumers who are not familiar with smart home services have more favorable attitudes toward hedonic smart home services when they are promotion-focused (vs. prevention-focused). In contrast, there is no significant difference in their attitudes toward utilitarian smart home services between promotion- and prevention-focused consumers. Our findings imply that regulatory focus may be an effective marketing and segmentation tool in promoting new smart home services and facilitating low-familiarity consumers' receptiveness to the services.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.20 no.4
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• pp.523-531
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• 2022

The International Atomic Energy Agency (IAEA) entails independent decision-making for the safety supervision of civil nuclear facilities. To evaluate and review the safety of nuclear facilities, the national regulatory body usually consults independent institutions or external committees. Technical Support Organizations (TSOs) include national laboratories, research institutions, and consulting organizations. Support from professional organizations in other countries may also be required occasionally. Most of the world's major nuclear power countries adopt an independent nuclear safety supervision model. Accordingly, China has continuously improved upon the construction of such a system by establishing the National Nuclear Safety Administration (NNSA) as the decision-making department for nuclear and radiation safety supervision, six regional safety supervision stations, the Nuclear and Radiation Safety Center (NSC), a nuclear safety expert committee, and the National Nuclear and Radiation Safety Supervision Technology R&D Base, which serves as the test, verification, and R&D platform for providing consultation and technical support. An R&D system, however, remains to be formed. Future endeavors must focus on improving the technical support capacity of these systems. As an enhancement from institutional independence to capability independence is necessary for ensuring the independence of China's nuclear safety regulatory institution, its regulatory capacity must be improved in the future.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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• pp.150-162
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• 2016

Objective: First-in-human dose estimation is an essential approach for successful clinical trials for drug development. In this study, we systematically compared first-in-human dose and human pharmacokinetic parameter estimation approaches. Methods: First-in-human dose estimation approaches divided into similar drug comparison approaches, regulatory guidance based approaches, and pharmacokinetic based approaches. Human clearance, volume of distribution and bioavailability were classified for human pharmacokinetic parameter estimation approaches. Results: Similar drug comparison approaches is simple and appropriate me-too drug. Regulatory guidance based approaches is recommended from US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding no-observed-adverse-effect level (NOAEL) or minimum anticipated biological effect level (MABEL). Pharmacokinetic based approaches are 8 approaches for human clearance estimation, 5 approaches for human volume of distribution, and 4 approaches for human bioavailability. Conclusion: This study introduced and compared all methods for first-in-human dose estimation. It would be useful practically to estimate first-in-human dose for drug development.

• Information Systems Review
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• v.11 no.2
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• pp.169-182
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• 2009

Due to natural oligopolistic industry characteristics and huge influences on national and home economy, Telco Industry is regarded as a regulated industry. Thus, telco companies, including CATV, prepare not only management accounting reports for internal use but also regulatory accounting reports to be submitted to the regulatory agency. For telco companies, smooth integration of these financial, managerial and regulatory reporting requirements with legacies such as billing system, network operating systems is important to achieve operational efficiency and overall competency. This research studies telco ERP cost module implementation in order to provide theoretical and practical guidance for integrated information system. Especially, case analysis focuses on cost reduction and network costing implementation that involves Building Block Costing methodologies.

• Safety and Health at Work
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• v.4 no.2
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• pp.95-99
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• 2013

Background: Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. Methods: After close analysis of the Italian and European reference regulatory framework and workrelated stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. Results: We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. Conclusion: This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

• Korean Journal of Clinical Pharmacy
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• v.21 no.4
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• pp.339-346
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• 2011

Over the past few decades, drug regulatory agencies in advanced countries have been emphasizing pharmacometrics as a tool for an effective and efficient drug evaluation. Despite this international movement, the value of pharmacometrics is still poorly recognized by the Korean drug evaluation system. This study aimed to analyze the current state of utilization of pharmacometrics by foreign drug regulatory agencies and develop a road map to guide the implementation pharmacometrics into the Korean drug evaluation system. MEDLINE and foreign drug regulatory agency database were extensively searched to obtain scientific research articles, guidance, regulations and pharmacometric review reports on foreign pharmacometric drug evaluation system. A systematic roadmap comprised of 3 stages to implement pharmacometrics in Korean drug evaluation system was formulated after analyzing the collected data in tune with the current evaluation system. Pharmacometrics is an urgently required tool to achieve an efficient drug evaluation and review in Korea. The road map developed by this study is expected to aid in setting up a policy to implement and utilize pharmacometrics in Korea.

• The Journal of The Korea Institute of Intelligent Transport Systems
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• v.19 no.2
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• pp.1-17
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• 2020

This Study aims to change and expand present traffic regulation from the human driver to Automated Vehicle(AV), we conducted an in-depth interview(IDI) into the traffic regulation service's strategy for an AV-related information consumer group(AVs and service developers) and a manager group (an information service management agency). The IDI results confirmed several important opinions and requirements for an information service by regulatory information manager groups (enough for AV development), such as a systematic need for dynamic regulatory information and a unified information management system. Also, we find out implications about adopting the Internet of Things (IoT) technology in traffic safety facilities to provide dynamic regulation information on the roads.

• Informatization Policy
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• v.29 no.2
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• pp.66-90
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• 2022

The radical digital transformation and development of the contactless digital economy in the wake of the COVID-19 pandemic are increasing the need to solve various problems such as conflicts of interest among market participants and delays in related laws and regulations. This study investigates the concept and characteristics of the contactless digital economy and identifies the related regulatory issues and resolutions through literature review, news article analysis, and expert interviews. From the literature review, it is identified that the contactless digital economy has eight hyper-innovation characteristics: hyper-intelligence, hyper-connectivity, hyper-convergence, hyper-personalization, hyper-automation, hyper-precision, hyper-diversity, and hyper-trust. From news article analyses and expert interviews, this study identifies various regulatory issues, such as competition between incumbents and new entrants, the collision of constitutional rights, collision of social values, conflict between market participants, absence of laws and regulations, and existence of excessive market power, and then proposes a series of resolutions.

• The Journal of Health Technology Assessment
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• v.1 no.1
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• pp.22-26
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• 2013

Objectives: Balancing benefits and risks through the drug life cycle has been discussed for many decades. The objective of this study was to review the processes and tools currently proposed for benefit-risk assessment of medicinal drugs. It aimed to establish scientific and efficient drug safety management system based on the synthetic analysis of benefit-risk evidence. Methods: We conducted a review of exiting literatures published by regulatory agencies or initiatives. Not only quantitative methodologies but also qualitative method were compared to understand their key characteristics for the benefit and risk assessment of drugs. Results: Recently, benefit-risk assessments have more structured approaches to decision making as part of regulatory science. Regulatory agencies such as European Medicines Agency, FDA have prepared plans to apply benefit-risk assessment to regulatory decision making. Also many initiatives such as IMI (Innovative Medicine Initiative) have conducted research and published reports about benefit-risk assessment. For benefit-risk assessment, four kinds of methods are necessary. Frameworks such as BRAT (Benefit Risk Action Team) framework, PrOACT-URL provide guidance for the whole process of decision-making. Metrics are measurements of risk benefit. The estimation techniques are methods to synthesis and combine evidences from various sources. The utility survey techniques are necessary to explicit preferences of various outcome from stakeholders. Conclusion: There is the lack of widely accepted, validated model for benefit-risk assessment. Nor there is an agreement among academia, industry, and government on methods for the quantitative valuation. It is also limited by available evidence and underlying assumptions. Nevertheless, benefit-risk assessment is fundamental to improve transparency, consistency and predictability for decision making through the structured systematic approaches.