• 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.

• The Korean Journal of Air & Space Law and Policy
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• v.22 no.1
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• pp.163-186
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• 2007

Charter flight in international air law has, from very beginning, not precisely defined by the International Civil Aviation Organization (lCAO) since 1947 when it came into being. By practice, the operation of charter traffic is, in its very beginning, the subject to the regulations of national rules and bilateral charter agreements (charter annex clause) within the framework of normal bilateral agreement of international air services. Taiwan had signed a series of bilateral air service agreement under the name of the Government of the Republic of China when Taiwan was recognized by the United Nations and major members of international community as the sole legal government representing China before 1971, but that situation was changed since then. Taiwan has only maintained diplomatic relations with 25 States, but maintained semi-official relations with major powers of the world. The former agreements were signed within the framework of the Vienna Convention on the Law of Treaties of 1969 while the latter agreements were signed within the framework of administrative and civil law of two countries which were not in the form of bilateral treaty signed by two sovereign States in its proper sense of international law. The legal regime of charter flights between Taiwan and Mainland China is regulated by special arrangements negotiated by delegated airlines and airlines association or private law institutions.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.77
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• pp.91-112
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• 2018

Mediation is one of several alternatives to litigation or arbitration. It is the most informal of the alternatives and the only one that gives the parties control over the outcome. The mediator in mediation is there to help the parties persuade each other that it is in their best interests to settle. As several advantages of mediation, it is considered as the fastest way to resolve a dispute because procedures associated with litigation are not imported into the process. In mediation, the client's resources are focused on resolving the dispute as opposed to building armaments of evidence to buttress legal and factual positions. The AAA commercial mediation rules and operations in the USA are very successful owing to professional training for mediators and simple procedures for mediation to the public. Comparison with USA mediation, KCAB mediation system has several weak points. KCAB mainly deals with administrative matters related to Foreign Trade Law. Therefore, it is necessary for KCAB to come up with more improved international commercial mediation. For example, mediation should be promoted to the public as who easily rely on litigation or arbitration. Second, Setting a rule for easy access to mediation is needed by bench marking AAA's mediation guidelines and operations. Third, professional mediators should be developed by establishing relevant ADR course in law schools. This article investigated some differences of mediation system between KCAB in Korea and AAA in USA, and present some suggestions in order to promote International commercial mediation in KCAB.

• The Korean Journal of Emergency Medical Services
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• v.5 no.1
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• pp.89-97
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• 2001

Recently, natural disasters happened to the Korea frequently. Disaster in the present society has been changed and increased it impacts and extent of danger as the society develops. So, Korean people feel uneasy about the unpredictable disaster. Therefore the capability of administration system, and cooperation and support between related organization become more necessary. This study aims to find out better ways of disaster management system which can protect people's lives and fortune from all sort of national disasters. To research policy reform, it is necessary to analyze disaster response organization(national disaster prevention countermeasures headquarters and so on), interorganizational relationship, law system etc. Especially, in this study, role appreciation of government was analyzed to get the rational policy reform measure. Suggestion : First, it is necessary Establishing a consolidated organization for disaster managing and united response organization is necessary such as Federal Emergency Management Agency(FEMA) which controls an over all aspects of disaster management. And it is necessary to develop Integrated Administrative Control System based on comprehensive plan. When the accidents happen, it needs to be many equipments and various specialized personnel. So, to manage a large scale of disaster, it is necessary to have interorganizational network system which many specialized organization including volunteer group are integrated. Also, as soon as the natural disaster happen, many professionals and volunteers are distributed to the spots of disaster in the right man in the right place. Finally, All the citizens have to keep safety rules, and also to take a safe action in ordinary daily life.

• The Journal of Fisheries Business Administration
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• v.46 no.3
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• pp.163-176
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• 2015

Nowadays, Under the current system of fisheries laws, fishery division and marine division are unified into one marine-fishery related law system indiscriminately. So they are not divided by nature. Moreover, terminology of fishery Law has been used by now in inappropriate conditions from Japanese 1951 fishery law systemct. Because fisheries administrative reorganization is also in parallel with the same logic as above, the reorganization of the legal system should be made. Finally, when the above mentioned problems is clearly defined and improvement is actually performed, more efficient management will be achieved through the beneficiary of more simple legal services. And so fisheries managers will be able to contribute to the development of the industries through more efficient management. While the existing framework of laws and regulations currently being enacted or established should be kept as much as possible, in order to ensure better control of fisheries resources and ensure sustainable development of related industries. Under various existing laws including the Fisheries Act, the Enforcement Regulations/enforcement rules, notice, instruction, established rule, the recognition of problems and improvements on the overall delegate legislative framework will be needed.

• Journal of radiological science and technology
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• v.47 no.1
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• pp.7-12
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• 2024

Medical institutions wishing to install and operate diagnostic radiation generators must complete appointment training within one year of appointment based on the 「Medical Act」 and the 「Rules on Safety Management of Diagnostic Radiation Generator Devices」 which will come into effect on January 1, 2024. Additionally, You must receive supplementary education every three years from the date you received it. The strengthening of safety management for diagnostic radiation generators used in medical institutions means that although the radiation exposure that may occur when using diagnostic radiation generators is low, the risk of carcinogenesis may be higher than previously evaluated. In addition, safety management of diagnostic radiation generators can be said to be an essential requirement because it has been reported that the incidence of leukemia and other diseases is increasing in diagnostic radiation tests. However, the safety management training targets and programs for radiation exposure management operated by other organizations other than diagnostic radiation generators are significantly different. In addition, since the public institutions that are responsible for radiation safety management are divided, there is a risk of duplicative, excessive, and under-administrative application to medical institutions and educational institutions that install and operate diagnostic radiation generators. Therefore, we would like to determine their consistency by comparing domestic and foreign related cases and the provisions of the 「Medical Act」 and the 「Nuclear Safety Act」.

• International Commerce and Information Review
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• v.14 no.1
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• pp.221-246
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• 2012

The purpose of this study aims to analyse the case on the violation of the Agreement on WTO-TRIMs in the China with auto parts case. The Agreement on Trade Related Investment Measures(TRIMs) are rules that apply to the domestic regulations, a country applies to foreign investors, often as part of an industrial policy. The agreement was agreed upon by all members of the WTO. The TRIMs Agreement bans any laws, policies or administrative regulations favouring domestic products. This includes government incentives to encourage corporations to use domestically made products as a way of creating or protecting local jobs. The Agreement on TRIMs is only one such restriction within the broader WTO regime. Policies such as local content requirements and trade balancing rules that have traditionally been used to both promote the interests of domestic industries and combat restrictive business practices are now banned. In many ways the Agreement on WTO-TRIMs is less significant than the WTO agreements on services, etc. The TRIMs Agreement does not involve any new rules or disciplines, referring only to the existing provisions under the GATT. However, by enforcing GATT provisions on 'national treatment', this short and simple agreement has had farreaching effects on auto parts, etc. Meanwhile, China has been members of the WTO late 2001, once the measures imposed high-rate tariff for import parts was intended to regulate importer of auto parts in order to avoid the high-rate tariff.

• Journal of Arbitration Studies
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• v.24 no.2
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• pp.3-31
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• 2014

As all aspects of international activity have kept growing in good transaction, transnational investments, joint ventures, and the licensing of intellectual property, it is inevitable for disputes to increase across national frontiers. International disputes can be settled by arbitration and ADR. In the situation presented in the paper, any dispute shall be finalized by arbitration and conciliation in the Gaeseong Industrial Complex. Inter-Korean Commercial Arbitration in the Gaeseong Industrial Complex has become the principal method of resolving disputes in trade, commerce, and investment in accordance with the "Agreement on South-North Commercial Dispute Settlement Procedures," "Agreement on Organization and Operation of Inter-Korean Commercial Arbitration Committee," and the Annexed Agreement on "Organization and Operation of Inter-Korean Commercial Arbitration Committee" (2013). But the follow-up measures of the said agreements have not been fulfilled. Some prerequisite measures of the Inter-Korean commercial arbitration must be satisfied. In order to proceed with arbitration and conciliation in the Gaeseong Industrial Complex, we need to ask the following: Does the status of an arbitrational matter? Should an agreement to arbitrate contain a choice of law clause? Should one provide for one arbitrator or three? How should the arbitrators be selected? What is the relation between party-appointed arbitrators and the presiding arbitrator (neutral arbitrator)? Do arbitrators compromise more than the litigation? Can conciliation be combined with arbitration? To execute the enactment of arbitration regulations, the contents of the Arbitration Rules of the Korean Commercial Arbitration Board (South) and the Korea International Trade Arbitration Committee (North), together with the Korean Arbitration Act and External Arbitration Act of North Korea and the UNCITRAL Model Arbitration Law and UNCITRAL l Arbitration Rules are reflected in the Rules. There are many aspects of the Inter-Korean Commercial Arbitration. It is essential to understand key elements; namely, the arbitration agreement, appointment of arbitrator, arbitral proceeding and arbitral award, and enforcement and setting aside of arbitral award. This research deals with five chapters. Chapter 1 provides the introduction. Chapter 2 deals with trade volume between South and North Korea and the kinds of dispute in Gaeseong. Chapter 3 addresses contents and follow-up measures of the agreement on the "South-North Commercial Dispute Settlement Procedures," "Agreement on Organization and Operation of Inter-Korean Commercial Arbitration Committee," and the Annexed Agreement on "Organization and Operation of Inter-Korean Commercial Arbitration Committee" (2013). Chapter 4 features the problems and tasks of the pertinent agreements. Chapter 5 gives the conclusion. Enabling parties to find an amicable solution to the dispute in the Gaeseong Industrial Complex can lead to a useful and appropriate framework either through direct negotiation or by resorting to conciliation or mediation in accordance with pertinent agreements and follow-up measures contained in the agreements.

• The Korean Journal of Air & Space Law and Policy
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• v.31 no.2
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• pp.99-143
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• 2016

General aviation and air transport are two wings of the civil aviation industry. Chinese air transport is developing rapidly, and has become the world second air transport system only second to US since 2005. However, Chinese civil aviation is far behind the world average level, and cannot meet requirements of economic construction and social development. The transition and structural adjustment of Chinese economy provide the general aviation with a unprecedented broad market. The prospect of general aviation is promising and anticipated. The development of general aviation industry needs the legislative supports, and the current legislative conditions of Chinese general aviation are undoubtedly far behind the realistic requirements. Accelerating the legislation in Chinese general aviation industry requires scientific legislation concept. First, Legislation must promote development of general aviation industry. The general aviation will serves as a Chinese emerging industry that boosts domestic demand, promotes employment and expedite domestic economic development. We should, based on both the concept of promoting the industrial development of general aviation and national industrial planning, enact and rectify relative laws and regulations. And we should also straighten out the relationship between aviation security and industrial development and promote the revolution of low-altitude airspace management in an all-round way, in order to improve the utilization rate of airspace resources, classify and establish airspace, simplify examination and approval procedure and intensify operation management. In addition, what we should do is to expedite the infrastructure layout construction, guide the differentiated but coordinated development of general aviation industries in various areas, establish a united supervision mechanism of general aviation, redistrict the responsibilities of Chinese Air Control Agency and set up legislation, law enforcement and judicial systems with clarified institutions, clear positioning and classified responsibilities, so as to usher in a new era of the legislative management of Chinese general aviation industry. Second, shift the focus from regulations to both regulations and services. Considering the particularity of the general aviation, we should use American practices for reference and take into account both regulation and service functions when enacting general aviation laws. For example, we should reduce administrative licensing and market supervision, and adopt "criteria" and "approval" management systems for non-commercial and commercial aviation. Furthermore, pay attention to social benefits. Complete social rescuing mechanism through legislation. It should be clarified in legislation that general aviation operators should take the responsibilities of, and ensure to realize social benefits of environmental protection and ecological balance .Finally, rise in line with international standards. Modify Chinese regulations which is inconsistent with international ones to remove barriers to international cooperation. Specify basic legislative principles. One is the principle of coordination. Realize coordination between the civil aviation and general aviation, between military aviation and civil aviation, and among departments. Two is the principle of pertinence. The general aviation has its own rules and specialties, needing to be standardized using specialized laws and regulations. Three is the principle of efficiency. To realize time and space values of general aviation, we should complete rules in aerospace openness, general aviation airport construction, general aviation operations, and regulation enforcement. Four is the principle of security. Balance the maximum use of resources of Chinese airspace and the according potential threats to Chinese national interests and social security, and establish a complete insurance system which functions as security defense and indemnificatory measure. Establish a unified legal system. Currently, the system of Chinese general aviation laws consists of national legislation, administrative laws and regulations and civil aviation regulations (CAR). Some problems exist in three components of the system, including too general content, unclear guarantee measures, incomplete implementation details, and lacking corresponding pertinence and flexibility required by general aviation regulations, stringency of operation management and standards, and uniformity of standards. A law and regulation system, centered on laws and consisting of administrative laws regulations, industrial regulations, implementation details, industrial policies and local laws and regulations, should be established. It is suggested to modify the Civil Aviation Law to make general aviation laws complete, enact the Regulations of General Aviation Development, and accelerate the establishment, modification and abolition of Chinese general aviation laws to intensify the coordination and uniformity of regulations.