• Journal of Pharmaceutical Investigation
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• v.36 no.6
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• pp.421-435
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• 2006

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.

• International Commerce and Information Review
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• v.8 no.4
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• pp.71-88
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• 2006

This article want to discuss on comparative research between CHIPS and Fedwire as the cross-border payment systems which America have and use at present. CHIPS is a New York-based automated private-sector clearing facility for large-dollar transfers. It is a central switch communication and settlement system whose 53 participating banks exchange same-day payment messages over dedicated communication lines linking each one to the CHIPS central computer. On January 22, 2001, CHIPS introduced immediate finality for payment released from the CHIPS queue. Unlike the Fedwire system, The CHIPS system is not a real-time gross settlement system. Instead, CHIPS is hybrid system that uses a computer program to select payment order in a queue for release to the receiving bank. CHIPS are governed by CHIPS Rules and Administrative Procedures. Fedwire system is a nationwide electronic fund-transfer system facilitating same-day transfers throughout the United States. It is a gross settlement system providing immediate credit to the receiving bank's master account. Communicating between a Federal Reserve Bank and Fedwire users can be either on-line or off-line. Fedwire transfers are governed by Subpart B of Regulation J, issued by the Federal Reserve Board, which incorporates U.C.C. Article 4A but preempts or supersedes any of its inconsistent provisions.

• TTA Journal
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• s.42
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• pp.101-113
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• 1995

지난 10월 23일부터 11월 17일까지 스위스 제네바의 ITU 회의장에서 146개 국가와 25개 국제기구에서 약 1300명이 참가한 가운데 세계전파통신 회의(World Radio communication Conference, WRC-95)가 개최되었다. WRC는 1993년 국제전기통신연합(ITU)이 조직을 바꾸면서 종래 WARC(세계 무선 주관청회의, World Administrative Radio Conference)를 계승하며, 한편 기술의 발달에 따른 통신 사업자, 제조업체 등의 민간 부문의 참여를 활성화하는 전파분야의 국제회의이다. 이 회의에서 결정된 사항은 각국이 따르도록 되어있으므로 국제화 시대를 살아가는 지금에 있어서 뿐만 아니라 전파의 국제적 사용이라는 특성을 고려할 때 그 중요성은 굳이 강조하지 않더라도 관계자 모두가 충분히 알고 있을 것이다. 우리나라에서는 박영일 전파방송관리국장을 비롯하여 모두 28명의 대표단이 참가하였으며, 이와 관련하여 1994년부터 2차례 진행되었던 WRC 준비반 회의(Conference Preparatory Meeting, 이하 CPM)에 참가하여 회의 준비를 하였고, 1995년 5월에는 대표단을 구성하여 각국의 제안 내용 검토와 우리의 제안 내용 관철을 위한 대책 등 착실한 준비를 하였고, 이번 회의에 RR 개정에 대한 우리의 의견과 주파수 분배표 수정에 대한 의견 등 모두 43건의 의견을 제안하여 회의에 임하였다. 이번 WRC-95의 주요 내용은 크게 2가지로 구별할 수 있다. 첫 번째는 그동안 전파규칙(Radio Regulation, 이하 RR)의 개정을 위하여 구성되었던 자발적 전문가 그룹(Voluntary Group of Experts)의 보고서를 토대로 기존의 RR을 수정 및 재구성하므로서 RR을 간소화 하기 위한 작업이 진행되었으며, 둘째로 기술의 발달에 따른 이동위성 서비스 등의 새로운 서비스를 도입하기 위한 주파수 분배표의 수정 작업이 진행되었다. 본 고에서는 이동위성 서비스 도입을 위한 이번 WRC-95의 회의 분위기를 전달함으로서 무선통신 관계자들이 WRC의 의미를 다시 한번 생각해 볼 수 있는 기회를 갖고자 한다.

• International Commerce and Information Review
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• v.10 no.3
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• pp.143-162
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• 2008

The Title 19 of the U.S. Code covers custom duties and is the heart of international trade regulation in the U.S.. Among the provisions in Title 19, is Chapter 4, the Tariff Act of 1930. Under U.S. Antidumping duty law, dumping occurs when `subject merchandise' is imported into the U.S. and sold at less than `fair value.' The administration of U.S. Antidumping duty law is shared between the Department of Commerce('Commerce') and International Trade Commission('USITC'). The U.S. Court of International Trade ("CIT") and the U.S. Court of Appeals for the Federal Circuit ("CAFC") decided the review of antidumping duty ("AD") determinations and administrative review results issued by the Commerce and the USITC, as well as the review of countervailing duty ("CVD") decisions. In Eurodif S.A. v. United States, the CAFC considered the important issue of whether the antidumping and countervailing duty laws apply to sales and purchases of services--in this case, the sale or purchase of enrichment services. Although the federal courts had considered the issue of whether a sale of enrichment services constitutes a sale of goods, the issue had never arisen in the context of the antidumping and countervailing duty laws. Also this is the first time that the Supreme Court has ever agreed to consider an antidumping case.

• Korean Journal of Occupational Health Nursing
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• v.14 no.1
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• pp.34-43
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• 2005

Purpose: The purpose of this study is to develop the curriculum model for occupational health nurse specialist in Korea. Method: Internet searching was conducted to analyze the type of master program for occupational health nurses in the U. S. To identify the importance of occupational health nurse specialist (OHNS)'s role, self-administrative questionnaire survey was done to335 occupational health nurses through postal mail and continuing education in 2003. SPSSWIN 10.0 was used for data analysis. Results: In the U. S., two main types of nurse practitioner program and nurse manager program are separately operated for occupational health nurses as master level. Under the governmental support, geographical and financial barrier can be decreased through the distance learning and the appointment of regional ERC. Most occupational health nurses recognized importantly the role of OHNS as direct care provider, educator, consultant, and manager. Conclusion: It is recommended that the job standard for OHNS needs to be developed, and regulation has to be changed for the diverse curriculum based on the need of occupational health nurses, and governmental support must be strengthened for occupational health nurses to apply more easily to the program.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.29 no.3
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• pp.278-288
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• 2019

Objectives: The objectives of this study are to summary controversy over health risks among semiconductor workers, to review major cancer risk results conducted in semiconductor operation and to evaluate occupational health activities in Korea for controlling hazardous agents generated in semiconductor operations Methods: Major occupational health issues that has been social controversies among semiconductor workers since 2007 were reviewed through an extensive literature, report and article review. Results: Since a female semiconductor worker aged 22 died from leukemia in 2007, job-association of a number of former semiconductor workers with various types of cancer and rare diseases have been denied by the Korea Workers' Compensation and Welfare Service (KWCWS), but some of them were later awarded compensation as an occupational disease by the administrative court. Two epidemiologic cancer risk studies conducted in Korea found increased risks in leukemia and non-Hodgkin's lymphoma among semiconductor workers. Various legal occupational health activities taken in semiconductor industry were found to fail to assess a complex characteristics of semiconductor operations, such as drastic changes in chemical use, processes, and technology, multiple exposure. National compensation regulation also showed the limitation to evaluate job-association of semiconductor workers who had worked in semiconductor operation. Conclusions: National legal measures should be taken to improve several occupational health activities and duties for protecting workers. In addition, the KWCWS program should be revised so that all workers who meet minimal job or environment associations can be compensated.

• The Korean Journal of Health Service Management
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• v.13 no.3
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• pp.1-12
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• 2019

Objectives: The purpose of this study was to provide hospital management diagnosis status and basic data required for the future development of hospital management diagnosis program. Methods: We conducted a questionnaire survey on administrative staff of manager level or over of medical institutions in B metropolitan city. Results: As a result of analyzing the relative influence of the needs by hospital management diagnosis indicator, the effect of financial analysis indicator, patient treatment record indicator and medical revenues indicator were high in the medical institutions with number of beds of 100 beds or over and general hospital level or over both on a hospital level and on an individual level. Conclusions: Since the existing laws or systems are centered on large major hospitals, the management environment is very unfavorable for small and medium hospitals as can be seen from the results of this study. Therefore, the government should improve the transparency and rationality of the hospital management environment in Korea through regulation and system reforms that can be applied to all medical institutions.

• Journal of the Korean Institute of Rural Architecture
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• v.23 no.2
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• pp.33-44
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• 2021

In this study, we investigated and analyzed changes about the landscape consciousness of Yeongam-gun residents, in chronological order. As a result, the landscape consciousness of 10 years ago and the present has not changed significantly. Also, the residents' consciousness of the Yeongam-gun landscape image has not changed from 10 years ago, and we recognize that it is necessary to preserve and form the natural landscape. As for the problem of urban landscape, the needs of residents for the development of urban infrastructure facilities and the development of tourist spots are higher than 10 years ago, and the problem of each landscape element is found as the formation and management of a road environment. It was found that the degree of satisfaction with the Yeongam landscape is generally below average, compared to 10 years ago. Residents' willingness to participate in landscape projects has changed as the number of respondents who do not want to participate has increased compared to 10 years ago, and the project method must be promoted by residents / administration / experts as one. The awareness is judged as administrative agencies need to change from the role of regulation-oriented in the past to the role of resident support and cooperation.

• Journal of the Korea Management Engineers Society
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• v.23 no.4
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• pp.19-31
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• 2018

Corruption is a serious political factor that distorts economic structure and slows economic development. In particular, the transition to the market opening economy increases the corruption incentives due to the transitional situation. The purpose of this study is to investigate the influencing factors on corruption using 2013 Myanmar Enterprise Survey data provided by World Bank. As a result of the analysis, it was found that the manager's willingness to dealing the regulation and the necessity of licensing had a positive relationship with corruption at the level of 90% and 95%, respectively. In the competitive environment factor, the intensity of the competition showed a significant increase at the level of 90%. In the institutional environment, the perception of social corruption and the obstacle of the taxation authorities increased the corruption. On the other hand, the increase in the instability of the political environment and strict enforcement of laws has been shown to reduce corruption. However, there was no significant relationship between managerial capacity, corruption of competitors, tax rate, and administrative environment.

• Journal of the Korea Safety Management & Science
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• v.24 no.1
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• pp.11-19
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• 2022

In order to find out the management and sanitation status of protective gear provided at the construction site, a case study and survey were conducted by visiting the site. As a result of the case study, inspection and management, disinfection, and storage of protective equipment were insufficient in both workplaces with less than 50 employees and workplaces with more than 100 employees. As a result of the survey, workers(66.2%), said they did not know how to identify hard hats(67.6.%), how to identify bad hard hats(60.8%), and how to identify bad safety belts (73.0%), even though workers(66.2%) were educated on protective gear, and those in charge of protective gear Non-specified(56.8%), regular inspection of the provided protective equipment was not performed(82.4%), and disinfection was not performed(90.5%). Therefore, as a management plan to maintain the performance of personal protective equipment, educational aspects, regular training on protective equipment, training on how to identify defective protective equipment, management of recording papers, technical aspects, strengthening of standards for placement of dedicated safety managers in small workplaces, participation of workers' representatives when selecting protective equipment, and selection of protective equipment for workers Providing opportunities, administrative aspects of protective equipment regulation and management, introduction of sanitary and cleanliness system, and selection of personnel in charge of protective equipment management were suggested.