• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.17 no.2
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• pp.213-226
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• 2019

Regulatory agency and licensee are preparing for the site restoration of Kori unit 1, the first commercial NPP in Korea, scheduled for 2031. Developing regulatory guidelines and strategies is essential for effective restoration work. Unfortunately, Korea does not have experience of site restoration of commercial NPPs. Therefore, it is important to review cases from experienced countries to establish a strategy and regulatory standards. The U.S. has had numerous soil remediation experiences using RESRAD and MARSSIM. However, formalized evaluation methodologies for subsurface soil have not yet been established in MARSSIM. This survey focused on subsurface soil remediation by reviewing the five decommissioned NPPs under regulation of the US NRC. Overall process of remediating a contaminated subsurface soil and groundwater was reviewed to identify considerations and lessons that could be applicable in Korea. In addition, an applied methodology for evaluation of contaminated subsurface soil and related major issues between regulatory agency and licensees were reviewed in detail to support establishment of remediation strategy for Kori unit 1.

• Journal of Distribution Science
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• v.12 no.2
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• pp.39-47
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• 2014

Purpose - The ultimate goal of a franchise system comes from its win-win strategy. Agency theory uses goal incongruity to examine complex contracting problems between buyers and suppliers. Goal incongruity within a contractual relationship can be defined as the agent's desire not to cooperate. It is the degree to which the contractual terms do not satisfy the agent's goals. The greater the goal incongruity between the agent and the contract, the more likely it is that the agent will meet the terms of the contract. Thus, goal incongruity between buyers and suppliers has close relationships with both behavioral and financial performance. This study tries to examine these relationships in the franchise context using a model including related variables, such as regulatory foci, financial performance, and opportunism, to explain the reasons that not all franchisees perform their best. In particular, the study examines the effects of goal incongruity on regulatory focus, and the effects of regulatory focus on performance and opportunism. In short, the objective is to determine goal incongruity's effect on regulatory foci, and the effect of regulatory focus on performance and opportunism. Research design, data, and methodology - This study used data collected from the franchisee managers of 104 franchisors in South Korea. The franchisors include more than 10 franchisees, the majority of whom have been in business for more than five years. The study also surveyed 104 franchisees, matched with their franchisors for the sake of a dyadic approach. The study used regression analysis to test the hypotheses. Results - H1 and H2 predicted that goal incongruity would decrease promotion focus and increase prevention focus. Supporting H1, the result indicates goal incongruity had a positive effect on promotion focus. However, H2 was not supported. Goal incongruity had no significant effect on prevention focus (β = -.375, t = -4.331 and β = -.145, t = -1.950, respectively). H3 and H4 predicted that promotion focus would increase financial performance and decrease opportunism. Supporting these hypotheses, the results indicate that promotion focus had a positive effect on financial performance and a negative effect on opportunism (β = .771, t = 7.899 and β = -.765, t = -6.778, respectively). H5 and H6 predicted that prevention focus would decrease financial performance and increase opportunism. However, the results do not support these hypotheses. The results indicate that prevention focus had no effects on opportunism or financial performance (β = -.130, t = -1.070 and β = .090, t = .641, respectively). Overall, the evidence generally supported the hypotheses. Conclusion - Goal incongruity between a franchisor and a franchisee increases the franchisee's financial performance and opportunism, and the relationship is mediated by promotion focus. Interestingly, however, prevention focus has no mediating effect between goal incongruity and performance. Even though no significant relation exists between goal incongruity and prevention focus, the results have two implications. First, decreasing goal incongruity can improve financial performance and suppress franchisee opportunism. Second, the relationship between goal incongruity and performance affects promotion-focused franchisees.

• Clean Technology
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• v.2 no.2
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• pp.30-41
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• 1996

Air pollution problems are serious and present significant challenges to the engineering research community. EPA's engineering research programs have shifted from a primary focus on $SO_2$ and NOx pollution control to more complex and more difficult problems such as indoor air quality, air toxics, and global climate change. EPA research engineers are working closely with other research organizations in both the private sector and other federal research organizations to identify, evaluate, and develop cost-effective engineering solutions. The APPCE works closely with the EPA regulatory and regional offices to ensure that the best engineering information is utilized to formulate and implement the Agency's environmental protection program.

• Electronics and Telecommunications Trends
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• v.34 no.1
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• pp.132-141
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• 2019

In this article, I summarize the various academic documents and regulatory agency reports on the Zero-Rating, and describes the type classification, major cases, and policy trends of major countries. In the case of Korea, the lack of academic research and the policy making work are relatively late compared to the advanced countries, so I hope that this paper will be helpful for the development of domestic academic research and policy direction in the future.

• Nuclear Engineering and Technology
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• v.54 no.1
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• pp.414-422
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• 2022

Presented in this paper is a methodology for combining a Bayesian statistical approach with Data Quality Objectives (a structured decision-making method) to provide increased levels of confidence in analytical data when approaching a waste boundary. Development of sampling and analysis plans for the characterisation of radioactive waste often use a simple, one pass statistical approach as underpinning for the sampling schedule. Using a Bayesian statistical approach introduces the concept of Prior information giving an adaptive sample strategy based on previous knowledge. This aligns more closely with the iterative approach demanded of the most commonly used structured decision-making tool in this area (Data Quality Objectives) and the potential to provide a more fully underpinned justification than the more traditional statistical approach. The approach described has been developed in a UK regulatory context but is translated to a waste stream from the Fukushima Daiichi Nuclear Power Station to demonstrate how the methodology can be applied in this context to support decision making regarding the ultimate disposal option for radioactive waste in a more global context.

• International conference on construction engineering and project management
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• 2015.10a
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• pp.376-380
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• 2015

Life-Cycle Cost Analysis (LCCA) for highway projects is known as an effective analytical technique that uses economic principles to evaluate long-term alternative investment options, especially for comparing the values of alternative pavement design structures and construction strategies. In the Unites States, the 2012 Moving Ahead for Progress in the 21^st Century Act (MAP-21) amended the United States Code to mandate that the United States Government Accountability Office (GOA) conducts a study of the best practices for calculating life-cycle costs and benefits for the federally funded highway projects in 2013. The RealCost 2.5CA program was developed and adapted as an official LCCA tool to comply with regulatory requirements for California state highway projects in 2013. Utilization of this California-customized LCCA software helps Caltrans to achieve substantial economic benefits (agency cost and road user cost savings) for highway projects. Proper implementation of LCCA for roadway construction and rehabilitation would deliver noticeable savings of agency's roadway maintenance cost especially in developing counties where financial difficulties exist.

• Safety and Health at Work
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• v.8 no.3
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• pp.318-321
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• 2017

This commentary presents the regulatory backgrounds and development of the national proficiency testing (PT) scheme on asbestos analysis in the Republic of Korea. Since 2009, under the amended Occupational Safety and Health Act, the survey of asbestos in buildings and clearance test of asbestos removal works have been mandated to be carried out by the laboratories designated by the Ministry of Employment and Labor (MOEL) in the Republic of Korea. To assess the performance of asbestos laboratories, a PT scheme on asbestos analysis was launched by the Korea Occupational Safety and Health Agency (KOSHA) on behalf of the MOEL in 2007. Participating laboratories are evaluated once a year for fiber counting and bulk asbestos analysis by phase contrast microscopy and polarized light microscopy, respectively. Currently, the number of laboratory enrollments is > 200, and the percentage of passed laboratories is > 90. The current status and several significant changes in operation, sample preparations, and statistics of assigning the reference values of the KOSHA PT scheme on asbestos analysis are presented. Critical retrospect based on the experiences of operating the KOSHA PT scheme suggests considerations for developing a new national PT scheme for asbestos analysis.

• The Journal of the Convergence on Culture Technology
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• v.10 no.3
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• pp.321-327
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• 2024

Out-of-home (Out-of-Home) advertising can be an effective means of delivering messages for preventing drowsy driving, given that it is exposed at locations and times where vehicle traffic occurs. This study investigated the influence of message framing of drowsy driving prevention OOH advertising and regulatory focus on the intention to drowsy driving prevention behaviors by an experimental study targeting 200 university students. The results showed an interaction effect between message framing and regulatory focus on the intention to drowsy driving prevention behaviors. While no significant differences were observed in the intention to drowsy driving prevention behaviors based on regulatory focus for positively framed messages, for negatively framed messages, a higher intention was observed when the prevention focus group rather than promotion focus group. This study focuses on two key areas: how messages are crafted (message framing) and the characteristics of the people who receive them (regulatory focus). By exploring these aspects, it provides valuable theoretical and practical knowledge. Essentially, it opens doors for creating message strategies that are finely tailored to suit the preferences of the audience. This advancement is vital for researchers and practitioners as it enhances the effectiveness of communication efforts.

• Environmental Engineering Research
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• v.14 no.4
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• pp.200-210
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• 2009

The modern era of water quality modeling in the United States began in the 1960s. Pushed by advances in computer technology as well as environmental sciences, water quality modeling evolved through five broad periods: (1) initial model development with mainframe computers (1960s - mid 1970s), (2) model refinement and generalization with minicomputers (mid 1970s - mid 1980s), (3) model standardization and support with microcomputers (mid 1980s - mid 1990s), (4) better model access and performance with faster desktop computers running Windows and local area networks linked to the Internet (mid 1990s - early 2000s), and (5) model integration and widespread use of the Internet (early 2000s - present). Improved computer technology continues to drive improvements in water quality models, including more detailed environmental analysis (spatially and temporally), better user interfaces and GIS software, more accessibility to environmental data from on-line repositories, and more robust modeling frameworks linking hydrodynamics, water quality, watershed and atmospheric models. Driven by regulatory needs and advancing technology, water quality modeling will continue to improve to better address more complicated water bodies and pollutant types, and more complicated management questions. This manuscript describes historical trends in water quality model development in the United States, reviews current efforts, and projects promising future directions.