• Journal of Pharmaceutical Investigation
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• v.30 no.4
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• pp.299-307
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• 2000

생물학적 동등성 시험은 동일 성분을 동량 함유한 제제가 유사조건에서 투여되었을 경우 그 유효성분이 전신순환혈이나 작용부위에서 유용하게 되는 속도 및 양에 큰 차이가 없음을 입증하는 시험이다. 즉 이미 제조허가 되어 시판중인 의약품과 동일한 품목의 제조허가를 받기 위한 경우이거나 생체이용률이 동일함을 증명하기 위해 실시하는 시험이다. 우리 나라에서는 1989년 1월 1일 이후 허가된 전문의약품으로서 신약과 동일한 의약품, 패취제제, 제제개선을 통해 흡수율을 높이는 경우에 생물학적 동등성 시험을 하도록 의무화하고 있다. 미국 FDA는 1975년 6월 생체이용률, 생물학적 동등성에 관한 규제안을 발표하였고, 우리 나라에서도 1988년 10월에 생물학적 동등성 시험 기준을 제정하였다. 유럽에서는 1991년 12월 CPMP(Committee for Proprietary Medicinal Products)에 의해 최초로 "생체이용률 및 생물학적 동등성에 대한 가이드라인"이 채택되었다. 그후 전문가 회의를 거쳐 규정 전반에 관한 것과 일반적 항목에 대한 검토가 이루어져 최종 개정된 가이드라인이 만들어졌다. 현재 in vivo 생체 이용률을 비교하는 생물학적 동등성 시험의 중요성이 증대되고 있고, 국제적으로도 각 국가별 생물학적 동등성 시험의 평가방법이나 기준설정에 대한 연구가 다양하게 이루어지고 있다. 또한 ICH에서도 생물학적 동등성 시험의 국제적 조화를 위한 시도가 이루어지고 있다. 우리 나라의 현행 생물학적 동등성 기준은 1998년 개정된 것을 사용하고 있으나 국제적 발전 추세에 맞추어 기준의 제고를 모색하고 있다. 그 일환으로 유럽의 "의약품의 생체이용률 및 생물학적 동등성 시험 가이드라인"을 소개하고자 한다., globunlin II의 두 component로 분리(分離)되었고 oryzenin은 시료(試料) 육우(陸羽) 132호(號), 등판(藤坂) 5호(號), 관산(關山) 재건(再建)에서는 oryzenin I, oryzenin II, oryzenin III의 3 component를 분리(分離)하였고 팔달(八達), 진흥(振興), 서광(瑞光), 은방주(銀坊主), 다마금(多摩錦), Pin Galw56의 6시료(試料)에서는 oryzenin II, oryzenin III의 2 component만 분리(分離)하였다. 3. 각(各) fraction을 여지전기영동(濾紙電氣泳動)하여 각(各) component의 농도곡선(濃度曲線)에 의해 함량(含量)을 구(求)한 결과(結果) albumin 0.26%, globulin I, 0.35%, globulin II, 0.32%, prolamin, 0.41%, oryzenin I, 0.30%, oryzenin II, 2.23%, oryzenin III, 2.66%이었다.미국의 경우 3일 이내 전화나 FAX로 보고하고, 10일이내 문서로써 보고하도록 되어 있다. 이러한 임상적 안전성 자료 관리에 대한 신속 보고 정의 및 기준에 대해서는 ICH에서도 논의가 되어 Step 4까지 다다르고 있으므로 앞으로 각 국에서의 적용만 남아있는 상태이고 보면 신약의 개발과 더불어 임상시험에서의 부작용등의 안전성 자료 관리에 대한 중요성은 더욱 강조될 것이다.공하는 음식의 섭취정도에도 영향을 주고 있으므로 학생들에게 학부모와 전담교사 및 학교영양사는 학생들에게 이상적인 아침식사에 대한 교육은 물론이고 아침식사를 실천할 수 있도록 다양한 방안에 대해 함께 연구해야 하겠다. 정부차원에서 학교급식에 아침식사 프로그램을 도입할

• Journal of Legislation Research
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• no.53
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• pp.177-211
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• 2017

In the course of the emergence and development of new ICT technologies and services such as Big Data, Internet of Things and Artificial Intelligence, the future will change by these new innovations in the Fourth Industrial Revolution. The future of this fourth industrial revolution will change and our future will be data-based society or economy. Since there is personal information at the center of it, the development of the economy through the utilization of personal information will depend on how to make the personal information protection laws. In Korea, which is trying to lead the 4th industrial revolution, it is a legal interest that can not give up the use of personal information, and also it is an important legal benefit that can not give up the personal interests of individuals who want to protect from personal information. Therefore, it is necessary to change the law on personal information protection in a rational way to harmonize the two. In this regard, this article discusses the problems of duplication and incompatibility of the personal information protection law, the scope of application of the personal information protection law and the uncertainty of the judgment standard, the lack of flexibility responding to the demand for the use of reasonable personal information, And there is a problem of reverse discrimination against domestic area compared to the regulated blind spot in foreign countries. In order to solve these problems and to improve the legislation of personal information protection in the era of the fourth industrial revolution, we proposed to consider both personal information protection and safe use by improving the purpose and regulation direction of the personal information protection law. The balance and harmony between the systematical maintenance of the personal information protection legislation and laws and regulations were also set as important directions. It is pointed out that the establishment of rational judgment criteria and the legislative review to clarify it are necessary for the constantly controversial personal information definition regulation and the method of allowing anonymization information as the intermediate domain. In addition to the legislative review for the legitimate and non-invasive use of personal information, there is a need to improve the collective consent system for collecting personal information to differentiate the subject and to improve the legislation to ensure the effectiveness of the regulation on the movement of personal information between countries. In addition to the issues discussed in this article, there may be a number of challenges, but overall, the protection and use of personal information should be harmonized while maintaining the direction indicated above.

• The Korean Journal of Air & Space Law and Policy
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• v.30 no.2
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• pp.201-248
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• 2015

In Korea the number of unlawful interference act on board aircrafts has been increased continuously according to the growth of aviation demand, and there were 55 incidents in 2000, followed by 354 incidents in 2014, and an average of 211 incidents a year over the past five years. In 1963, a number of states adopted the Convention on Offences and Certain Other Acts Committed on Board Aircraft (the Tokyo Convention 1963) as the first worldwide international legal instrument on aviation security. The Tokyo Convention took effect in 1969 and, shortly afterward, in 1970 the Convention for the Suppression of Unlawful Seizure of Aircraft(the Hague Convention 1970) was adopted, and the Convention for the Suppression of Unlawful Acts Against the Safety of Civil Aviation(the Montreal Convention 1971) was adopted in 1971. After 9/11 incidents in 2001, to amend and supplement the Montreal Convention 1971, the Convention on the Suppression of Unlawful Acts Relating to International Civil Aviation(the Beijing Convention 2010) was adopted in 2010, and to supplement the Hague Convention 1970, the Protocol Supplementary to the Convention for the Suppression of Unlawful Seizure of Aircraft(the Beijing Protocol 2010) was adopted in 2010. Since then, in response to increased cases of unruly behavior on board aircrafts which escalated in both severity and frequency,, the Montreal Protocol which is seen as an amendment to the Convention on Offences and Certain Other Acts Committed on Board Aircraft(the Tokyo Convention 1963) was adopted in 2014. Korea ratified the Tokyo Convention 1963, the Hague Convention 1970, the Montreal Convention 1971, the Montreal Supplementary Protocol 1988, and the Convention on the Marking of Plastic Explosive 1991 which have proven to be effective. Under the Tokyo Convention ratified in 1970, Korea further enacted the Aircraft Navigation Safety Act in 1974, as well as the Aviation Safety and Security Act that replaced the Aircraft Navigation Safety Act in August 2002. Meanwhile, the title of the Aviation Safety and Security Act was changed to the Aviation Security Act in April 2014. The Aviation Security Act is essentially an implementing legislation of the Tokyo Convention and Hague Convention. Also the language of the Aviation Security Act is generally broader than the unruly and disruptive behavior in Sections 1-3 of the model legislation in ICAO Circular 288. The Aviation Security Act has reflected the considerable parts of the implementation of national legislation under the Beijing Convention and Beijing Protocol 2010, and the Montreal Protocol 2014 that are the modernized international conventions relating to aviation security. However, in future, when these international conventions would come into effect and Korea would ratify them, the national legislation that should be amended or provided newly in the Aviation Security Act are as followings : The jurisdiction, the definition of 'in flight', the immunity from the actions against the aircraft commander, etc., the compulsory delivery of the offender by the aircraft commander, etc., the strengthening of penalty on the person breaking the law, the enlargement of application to the accomplice, and the observance of international convention. Among them, particularly the Korean legislation is silent on the scope of the jurisdiction. Therefore, in order for jurisdiction to be extended to the extra-territorial cases of unruly and disruptive offences, it is desirable that either the Aviation Security Act or the general Crime Codes should be revised. In conclusion, in order to meet the intelligent and diverse aviation threats, the Korean government should review closely the contents of international conventions relating to aviation security and the current ratification status of international conventions by each state, and make effort to improve the legislation relating to aviation security and the aviation security system for the ratification of international conventions and the implementation of national legislation under international conventions.

• Proceedings of the Korea Technology Innovation Society Conference
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• 2015.05a
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• pp.545-570
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• 2015

Korea is among the ten countries with the largest R&D budget and the highest R&D investment-to-GDP ratio, yet the subject of security and protection of R&D results remains relatively unexplored in the country. Countries have implemented in their legal systems measures to properly protect cutting-edge industrial technologies that would adversely affect national security and economy if leaked to other countries. While Korea has a generally stable legal framework as provided in the Regulation on the National R&D Program Management (the "Regulation") and the Act on Industrial Technology Protection, many difficulties follow in practice when determining details on security management and obligations and setting standards in carrying out national R&D projects. This paper proposes to modify and improve security level classification standards in the Regulation. The Regulation provides a dual security level decision-making system for R&D projects: the security level can be determined either by researcher or by the central agency in charge of the project. Unification of such a dual system can avoid unnecessary confusions. To prevent a leakage, it is crucial that research projects be carried out in compliance with their assigned security levels and standards and results be effectively managed. The paper examines from a practitioner's perspective relevant legal provisions on leakage of confidential R&D projects, infringement, injunction, punishment, attempt and conspiracy, dual liability, duty of report to the National Intelligence Service (the "NIS") of security management process and other security issues arising from national R&D projects, and manual drafting in case of a breach. The paper recommends to train security and technological experts such as industrial security experts to properly amend laws on security level classification standards and relevant technological contents. A quarterly policy development committee must also be set up by the NIS in cooperation with relevant organizations. The committee shall provide a project management manual that provides step-by-step guidance for organizations that carry out national R&D projects as a preventive measure against possible leakage. In the short term, the NIS National Industrial Security Center's duties should be expanded to incorporate national R&D projects' security. In the long term, a security task force must be set up to protect, support and manage the projects whose responsibilities should include research, policy development, PR and training of security-related issues. Through these means, a social consensus must be reached on the need for protecting national R&D projects. The most efficient way to implement these measures is to facilitate security training programs and meetings that provide opportunities for communication among industrial security experts and researchers. Furthermore, the Regulation's security provisions must be examined and improved.

• The Korean Journal of Air & Space Law and Policy
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• v.32 no.1
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• pp.3-51
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• 2017

From a historical point of view, while the Warsaw Convention was passed in 1924 to regulate the unified judicial responsibility in the global air transportation industry, protection of airline consumers was somewhat lacking in protecting air carriers. In principle, the air carrier does not bear any obligation or liability when the aircraft is not operated normally due to natural disasters such as typhoon or heavy snowfall. However, in recent years, in developed countries such as the US and Europe, there has been a movement in which regulates the air carriers' obligation to protect their passengers even if there is no misconduct or negligence. Furthermore, the legislation of such advanced countries imposes an obligation on the airlines to compensate the loss separately from damages in case the abnormal operation of the aircraft is not caused by force majeure but caused by their negligence. Under this historical and international context, Korea is also modifying the system of aviation consumer protection by referring to other foreign legislation. However, when compared with foreign countries, our norm has a few drawbacks. First, the airline's protection or care obligations are mixed with the legal liability for damages in the provision, which seems to be due to the lack of understanding of the airline's passenger protection obligation. The liability for damages, which is governed by the International Convention or the Commercial Act, shall be determined by judging the cause of the airline's liability in respect of the damage of the individual passenger in the course of the air transportation. However, the duty to care and the burden for compensation shall be granted to all passengers who feel uncomfortable with the abnormal operation regardless of the cause of the accident. Also, our compensation system for denied boarding due to oversale is too low compared to the case of foreign countries, and setting the compensation amount range differently based on the time for the re-routing is somewhat unclear. Regarding checked-baggage claim, it will be necessary to refund the fee only from the fact that the baggage is delayed without asking whether there is any damage occurred from the delayed baggage. This is the content of the duty to care, which is different from the current Commercial Act or the international convention, in which responsibility is different depending on whether the airline takes all the necessary measures in order to prevent delaying of the baggage. The content of force majeure, which is a requirement for exemption from the obligation to care passengers on the airplane, shall be reconsidered. Maintenance for safe navigation is not considered to be included in force majeure, and connection to airplanes, airport conditions are disputable. According to the EC Regulation, if the cause of the abnormal operation of the airline is force majeure, the airline's compensation obligation is exempted but the duty to care of airline company is still meaningful. Furthermore, even if the main role of aviation consumer protection is on an airline, it is the responsibility of government agencies to supervise the fulfillment of such protection obligations. Therefore, it is necessary for the Korean government to actively take measures such as enforcing incentives for airlines that faithfully fulfill their obligation to care and imposed penalties on the contrary.

• Journal of Preventive Medicine and Public Health
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• v.31 no.1 s.60
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• pp.139-156
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• 1998

Diving related disease including decompression sickness is an important occupational health problem and diving fishermen remain a fairly hazardous occupation in Korea. To prevent diving related disease, we investigate diving patterns, incidence of diving related diseases, and contributing factors of 433 diving fishermen of three coast interviewing and mailing questionnaire in 1996. Mean age of divers was 39.7 years, ranged from 24 to 58 years, 92.8% of these were male, and 58.4% of divers were high school graduates. Mean duration of work as a diver was 12.9 years, ranged from 2 to 40 years. It was found that 70.4% of divers were using hookah system, 22.2% of helmet, and only 2.5% SCUBA. About half of them have learned diving skills from other divers. The peak season of diving was from April to June and mean working days were 20.3 days per month during the peak season. On the average, the divers dived 5-6 times, ranged from 1 to 10 times a day with 51.1 minutes of diving time, ranged from 20 to 120 minutes, at 30 m or 40 m in depth, and 35.5 minute of interval on surface. Most divers ascended slowly making decompression stop, yet the decompression profile used was not based on any scientific knowledge except for their own experiences. It appeared that each diving system had slightly different diving patterns. There were 282(65.0%) divers that suffered from DCS in 1995 and 31.2% of divers were given recompression therapy at a medical facility since they worked as diving fishermen. Skin and musculoskeletal complaints were common symptoms of DCS and 39% of divers experienced a voiding difficulty. In univariate analysis, females have an increased frequency of DCS(93% vs 66% for males). Old age, long duration of work, helmet diving, diving time, diving depth, repetitive diving, and blow up were all contributing factors to DCS. It was found that most diving patterns exceed no decompression limit and did not use the standard decompression table. This suggests that most of divers are at high risk of developing diving related disease with prolonged dives and lengthy repetitive diving in deep depth. Considering the diving patterns and economic aspect of professional diving, the incidence of DCS among diving fishermen in Korea will not decrease in the near future. These findings suggest that periodical health surveillance for divers, and education of health and safety are important for reducing the risk of diving related disease in the population of diving fishermen.

• The Korean Journal of Air & Space Law and Policy
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• v.25 no.1
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• pp.97-158
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• 2010

The purpose of this paper is to research on the contents and improvement of national legislations relating to space development in Korea to make the sustainable progress of space development project in Korea. Korea has launched its first satellite KITST-1 in 1992. The National Space Committee has established "The Space Development Promotion Basic Plan" in 2007. The plan addressed the development of total 13 satellites by 2010 and the space launch vehicle by 2020, and the launch of moon exploration spaceship by 2021. Korea has built the space center at Oinarodo, Goheng Province in June 2009. In Korea the first small launch vehicle KSLV-1 was launched at the Naro Space Center in August 2009, and its second launch was made in June 2010. The United Nations has adopted five treaties relating to the development of outer space as follows : The Outer Space Treaty of 1967, the Rescue and Return Agreement of 1968, the Liability Convention of 1972, the Registration Convention of 1974, and the Moon Treaty of 1979. All five treaties has come into force. Korea has ratified the Outer Space Treaty, the Rescue and Return Agreement, the Liability Convention and the Registration Convention excepting the Moon Treaty. Most of development countries have enacted the national legislation relating to the development of our space as follows : The National Aeronautic and Space Act of 1958 and the Commercial Space Act of 1998 in the United States, Outer Space Act of 1986 in England, Establishment Act of National Space Center of 1961 in France, Canadian Space Agency Act of 1990 in Canada, Space Basic Act of 2008 in Japan, and Law on Space Activity of 1993 in Russia. There are currently three national legislations relating to space development in Korea as follows : Aerospace Industry Development Promotion Act of 1987, Outer Space Development Promotion Act of 2005, Outer Space Damage Compensation Act of 2008. The Ministry of Knowledge Economy of Korea has announced the Full Amendment Draft of Aerospace Industry Development Promotion Act in December 2009, and it's main contents are as follows : (1) Changing the title of Act into Aerospace Industry Promotion Act, (2) Newly regulating the definition of air flight test place, etc., (3) Establishment of aerospace industry basic plan, establishment of aerospace industry committee, (4) Project for promoting aerospace industry, (5) Exploration development, international joint development, (6) Cooperative research development, (7) Mutual benefit project, (8) Project for furthering basis of aerospace industry, (9) Activating cluster of aerospace industry, (10) Designation of air flight test place, etc., (11) Abolishing the designation and assistance of specific enterprise, (12) Abolishing the inspection of performance and quality. The Outer Space Development Promotion Act should be revised with regard to the following matters : (1) Overlapping problem in legal system between the Outer Space Development Promotion Act and the Aerospace industry Development promotion Act, (2) Distribution and adjustment problem of the national research development budget for space development between National Space Committee and National Science Technology Committee, (3) Consideration and preservation of environment in space development, (4) Taking the legal action and maintaining the legal system for policy and regulation relating to space development. The Outer Space Damage Compensation Act should be revised with regard to the following matters : (1) Definition of space damage and indirect damage, (2) Currency unit of limit of compensation liability, (3) Joint liability and compensation claim right of launching person of space object, (4) Establishment of Space Damage Compensation Council. In Korea, it will be possible to make a space tourism in 2013, and it is planned to introduce and operate a manned spaceship in 2013. Therefore, it is necessary to develop the policy relating to the promotion of commercial space transportation industry. Also it is necessary to make the proper maintenance of the current Aviation Law and space development-related laws and regulations for the promotion of space transportation industry in Korea.

• Korean Journal of Soil Science and Fertilizer
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• v.45 no.2
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• pp.293-300
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• 2012

This study was to investigate the unsuitable rate of the storage facilities, the changes in corrosion process over time after installation according to the status, the time to install the facilities, years elapsed after facilities installation, inspection of methods and motivation, and so on, based on the results of the inspection at the petroleum storage facilities conducted by domestic soil-relate specialized agency to derive optimal management plans which meet the status of soil contamination facilities. The results showed that the facilities more than 5 years after the initial leak test at the time of the installation need to be inspected periodically by considering costs of leak test and remediation of polluted soil. The inspection period can be decided by cost and leak test methods showing discrepancies for the results obtained from individual test whether it was direct or indirect. To compensate these matters, we suggested that the direct inspection method on regular schedule is recommended. On the other hand, the inspection can be voluntarily completed to ease burden of the results by inspection or equivalent level to this inspection method. Also, it may need improved construction supervision and performance test system to minimize the occurrence of the nature defects in installing the facilities as well as the upgrade program for the facilities during intervals of inspection period.

• The Korean Society of Law and Medicine
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• v.17 no.1
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• pp.299-346
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• 2016

There were also various decisions made in medical area in 2015. In the case that an inmate in a sanatorium was injured due to the reason which can be attributable to the sanatorium and the social welfare foundation that operates the sanatorium request treatment of the patient, the court set the standard of fixation of a party in medical contract. In the case that the family of the patient who was declared brain dead required withdrawal of meaningless life sustaining treatment but the hospital rejected and continued the treatment, the court made a decision regarding chargeable fee for such treatment. When it comes to the eye brightening operation which received measure of suspension from the Ministry of Health and Welfare for the first time in February, 2011, because of uncertainty of its safety, the court did not accept the illegality of such operation itself, however, ordered compensation of the whole damage based on the violation of liability for explanation, which is the omission of explanation about the fact that the cost-effectiveness is not sure as it is still in clinical test stage. There were numerous cases that courts actively acknowledged malpractices; in the cases of paresis syndrome after back surgery, quite a few malpractices during the surgery were acknowledged by the court and in the case of nosocomial infection, hospital's negligence to cause such nosocomial infection was acknowledged by the court. There was a decision which acknowledged malpractice by distinguishing the duty of installation of emergency equipment according to the Emergency Medical Service Act and duty of emergency measure in emergency situations, and a decision which acknowledged negligence of a hospital if the hospital did not take appropriate measures, although it was a very rare disease. In connection with the scope of compensation for damage, there were decisions which comply with substantive truth such as; a court applied different labor ability loss rate as the labor ability loss rate decreased after result of reappraisal of physical ability in appeal compared to the one in the first trial, and a court acknowledged lower labor ability loss rate than the result of appraisal of physical ability considering the condition of a patient, etc. In the event of any damage caused by malpractice, in regard to whether there is a limitation on liability in fee charge after such medical malpractice, the court rejected the hospital's claim for setoff saying that if the hospital only continued treatments to cure the patient or prevent aggravation of disease, the hospital cannot charge Medical bills to the patient. In regard to the provision of the Medical Law that prohibit medical advertisement which was not reviewed preliminarily and punish the violation of such, a decision of unconstitutionality was made as it is a precensorship by an administrative agency as the deliberative bodies such as Korean Medical Association, etc. cannot be denied to be considered as administrative bodies. When it comes to the issue whether PRP treatment, which is commonly performed clinically, should be considered as legally determined uninsured treatment, the court made it clear that legally determined uninsured treatment should not be decided by theoretical possibility or actual implementation but should be acknowledged its medical safety and effectiveness and included in medical care or legally determined uninsured treatment. Moreover, court acknowledged the illegality of investigation method or process in the administrative litigation regarding evaluation of suitability of sanatorium, however, denied the compensation liability or restitution of unjust enrichment of the Health Insurance Review & Assessment Service and the National Health Insurance Corporation as the evaluation agents did not cause such violation intentionally or negligently. We hope there will be more decisions which are closer to substantive truth through clear legal principles in respect of variously arisen issues in the future.

• Journal of the Korean Association of Geographic Information Studies
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• v.19 no.4
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• pp.52-62
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• 2016

Smart City is urban development for complex problem solving that provides convenience and safety for citizens, and it is a blueprint for future cities. In 2008, the Korean government defined the construction, management, and government support of U-Cities in the legislation, Act on the Construction, Etc. of Ubiquitous Cities (Ubiquitous City Act), which included definitions of terms used in the act. In addition, the Minister of Land, Infrastructure and Transport has established a "ubiquitous city master plan" considering this legislation. The concept of U-Cities is complex, due to the mix of informatization and urban planning. Because of this complexity, the foundation of relevant regulations is inadequate, which is impeding the establishment and implementation of practical plans. Smart City intelligent service facilities are not easy to define and classify, because technology is rapidly changing and includes various devices for gathering and expressing information. The purpose of this study is to complement the legal definition of the intelligent service facility, which is necessary for integrated management and operation. The related laws and regulations on U-City were analyzed using text-mining techniques to identify insufficient legal definitions of intelligent service facilities. Using data gathered from interviews with officials responsible for constructing U-Cities, this study identified problems generated by implementing intelligent service facilities at the field level. This strategy should contribute to improved efficiency management, the foundation for building integrated utilization between departments. Efficiencies include providing a clear concept for establishing five-year renewable plans for U-Cities.