• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

• The Korean Journal of Air & Space Law and Policy
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• v.28 no.1
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• pp.115-157
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• 2013

Some contracting States of the Convention on International Civil Aviation (commonly known as the Chicago Convention) issue FAOC(Foreign AOC and/or Operations Specifications) and conduct various safety audits for the foreign operators. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident, it is the source of concern from the legal as well as economic perspectives. FAOC of the USA doubly burdens the other contracting States to the Chicago Convention because it is the requirement other than that prescribed by the Chicago Convention of which provisions are faithfully observed by almost all the contracting States. The Chicago Convention in its Article 33 stipulates that each contracting State recognize the validity of the certificates of airworthiness and licenses issued by other contracting States as long as they meet the minimum standards of the ICAO. Consequently, it is submitted that the unilateral action of the USA, China, Mongolia, Australia, and the Philippines issuing the FOAC to the aircraft of other States is against the Convention. It is worry some that this breach of international law is likely to be followed by the European Union which is believed to be in preparation for its own unilateral application. The ICAO established by the Chicago Convention to be in charge of safe and orderly development of the international civil aviation has been in hard work to both upgrade and emphasize the safe operation of aircraft. As the result of these endeavors, it prepared a new Annex 19 to the Chicago Convention with the title of "Safety Management" and with the applicable date 14 November 2013. It is this Annex and other ICAO documents relevant to the safety that the contracting States to the Chicago Convention have to observe. Otherwise, it is the economical burden due to probable delay in issuing the FOAC and bureaucracies combined with many different paperworks and regulations depending on where the aircraft is flown. It is exactly to avoid this type of confusion and waste that the Chicago Convention aimed at when it was adopted in 1944. The State of the operator shall establish a system for both the certification and the continued surveillance of the operator in accordance with ICAO SARPs to ensure that the required standards of operations are maintained. Certainly the operator shall meet and maintain the requirements established by the States in which it operate. The authority of a State stops where the authority of another State intervenes or where the former has yielded its power by an international agreement for the sake of international cooperation. Hence, it is not within the realm of the State to issue FAOC towards foreign operators for the reason that these foreign operators are flying in and out of the State. Furthermore, there are other safety audits such as ICAO USOAP, IATA IOSA, FAA IASA, and EU SAFA that assure the safe operation of the aircraft, but within the limit of their power and in compliance with the ICAO SARPs. If the safety level of any operator is not satisfactory, the operator could be banned to operate in the contracting States with watchful eyes until the ICAO SARPs are met. This time-honoured practice has been applied without any serious problems. Besides, we have the new Annex 19 to strengthen and upgrade with easy reference for contracting States. We don't have no reason to introduce additional burden to the States by unilateral actions of some States. These actions have to be corrected. On the other hand, when it comes to the carriage of the Personal or Pilot Log Book, the Korean regulation requiring it is in contrast with other relevant provisions of USA, USOAP, IOSA, and SAFA. The Chicago Convention requires in its Articles 29 and 34 only the carriage of the Journey Log Book and some other certificates, but do not mention the Personal Log Book at all. Paragraph 5.1.1.1 of Annex 1 to the Chicago Convention even makes it clear that the carriage in the aircraft of the Personal Log Book is not required on international flights. The unique Korean regulation in this regards giving the unnecessary burden to the national flag air carriers has to be lifted at once.

• Korean Journal of Clinical Laboratory Science
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• v.50 no.1
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• pp.71-76
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• 2018

This study examined the status of the laboratory biosafety of researchers in Korea during 03 Jan 2017~25 Mar 2017. Questionnaires were given out to 500 researchers working with pathogens in the laboratory of universities and institutes. According to the results, the respondents showed a high level of awareness but not compliance on the overall biosafety rules and regulations. Regarding the Biosafety facility level, 279 (55.8%) of respondents answered "know" and 221 (44.2%) of respondents answered "no". Despite the insufficient safety equipment and biosafety plans, researchers believed that appropriate safety measures could protect the workers and that their laboratories are safe. In a study involving biosafety education, 80% of the researchers had been trained in laboratory safety and 20% had never received safety education. The need for biosafety education was 66% and the satisfaction rate of education was 46%. These results suggest that the researchers already had experience in biosafety training, but they believed that continuing education is necessary. In addition, there were opinions that the most important thing to improve the biosafety status is to strengthen the training program and education system. In conclusion, it is necessary to develop a better training system for laboratory biosafety regarding the exposure risks.

• Journal of the Korean Society of Surveying, Geodesy, Photogrammetry and Cartography
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• v.23 no.3
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• pp.221-231
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• 2005

Though Digital Map Ver. 2.0 is adequate to GIS, the possibility to gain information from its external form and the ease of producing paper map had retrogressed. In this research, concerned with the problems, we plan to make Digital Map Ver. 2.0, which satisfies the conditions of GIS. It will have geometrical and logical data structure, and also possess informative ability as much as that of Ver. 1.0. For the study, the process to analyze the topographic code, color, code priority order, etc. of paper relief map, digital map Ver. 1.0, and digital map Ver. 2.0 was taken. For the topographical feature with diverse expression, we changed the portrayal of digital map Ver. 2.0 to make it fit the regulations of map portrayal. At the point of topographic code priority order, the rule is to arrange them in the same order as the real territory. However, we made a special code in the case of any change of the locational order. According to the property of this study, we observe the regulations of map portrayal, for the elements related to subjective sense, such as colors. And we give priority on the data construction when the portrayal of topographical feature and the schema of GIS database system are contradictory.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.18 no.3
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• pp.22-30
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• 2017

This paper presents the research results of a light weight through topology optimization and structural safety evaluation through structural analysis of a pressure system structure installed in an off-shore plant. Conducting a structure design according to the wind load and the dynamic load at sea in addition to a self-load and structure stability evaluation are very important for structures installed in off-shore plants. In this study, the wind and dynamic load conditions according to the DNV classification rule was applied to the analysis. The topology optimization method was applied to the structure to obtain a lightweight shape. Phase optimization analysis confirmed the stress concentration portion. Topology optimization analysis takes the shape by removing unnecessary elements in the design that have been designed to form a rib shape. Based on the analysis results about the light weight optimal shape, a safety evaluation through structural analysis and suitability of the shape was conducted. This study suggests a design and safety evaluation of an off-shore plant structure that is difficult for structural safety evaluations using an actual test.

• The KIPS Transactions:PartA
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• v.16A no.3
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• pp.159-168
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• 2009

In this paper, we present an efficient way of implementing OpenGL ES 1.1 standard for the environments with hardware-supported OpenGL API, such as desktop PCs. Although OpenGL ES was started from the existing OpenGL features, it becomes a new three-dimensional graphics library customized for embedded systems through introducing fixed-point arithmetic operations, buffer management with fixed-point data type supports, completely new texture mapping functionalities and others. Currently, it is the official three dimensional graphics library for Google Android, Apple iPhone, PlayStation3, etc. In this paper, we achieved improvements on the arithmetic operations for the fixed-point number representation, which is the most characteristic data type for OpenGL ES. For the conversion of fixed-point data types to the floating-point number representations for the underlying OpenGL, we show the way of efficient conversion processes even with satisfying OpenGL ES standard requirements. We also introduced a simple memory management scheme to mange the converted data for the buffer containing fixed-point numbers. In the case of texture processing, the requirements in both standards are quite different and thus we used completely new software-implementations. Our final implementation result of OpenGL ES library provides all of over than 200 functions in OpenGL ES 1.1 standard and completely passed its conformance test, to show its compliance with the standard. From the efficiency viewpoint, we measured its execution times for several OpenGL ES-specific application programs and achieved at most 33.147 times improvements, to become the fastest one among the OpenGL ES implementations in the same category.

• Proceedings of the IEEK Conference
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• 2003.07a
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• pp.450-453
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• 2003

본 논문에서는 그룹별 가변 길이 직교코드 다중화를 이용한 OFDM (orthogonal frequency division multiplexing) 전송방식의 제안하고, 그룹별로 동일한 부반송파 개수를 가정하여 코드 길이에 따른 시스템 성능과 복잡도를 분석함으로써 최적의 시스템 파라미터들을 결정한다. 제안된 방식에서는 상호 상관성이 낮은 부반송파들로 동일 반송파 그룹으로 구분함으로써 부반송파 전체를 다수의 부반송파 그룹으로 나누고, 그룹마다 부반송파 개수와 동일한 길이의 직교코드들을 사용하여 다중화하여 전송한다. 따라서, 제안된 시스템을 사용하면 적절한 시스템 파라미터의 선정을 통하여 부반송파 전체를 하나의 그룹으로 하는 기존의 직교코드 다중화 방식에[2] 비하여 다이버시티 이득은 유지하면서 시스템 복잡도를 크게 줄일 수 있다. 또한, 제안된 직교코드 다중화 전송방식에서는 수신기에서 직교코드들간의 직교성 복원이 필수적이며, 수신기에서 불완전한 채널등화는 인접한 직교코드들 간에 상호 간섭을 유발하는 요인이 된다. 따라서, 채널추정 오류의 정도가 증가함에 따라 직교코드들 간의 상호 간섭으로 인하여 증가하는 비트오류를 줄이기 위하여 채널추정 오류의 정도에 따라 블록길이와 블록 인터리버 구조를 조절하여 시스템을 최적화 한다. 가변 길이 직교코드로는 길이에 상관 없이 직교성을 유지하며 에너지의 균등 분배가 가능한 DFT (discrete Fourier transform) 코드를 사용한다. 최적 시스템 파라미터를 결정하기 위하여 모의실험을 통하여 코드 길이에 따른 시스템 성능을 분석한다. 또한, 채널추정 오류가 존재하는 경우에 시스템 성능을 분석한다. 마지막으로, 채널 부호화를 적용하는 경우에 시스템 파라미터들을 최적화함으로써 부호화 이득이 시스템 성능과 시스템 복잡도 감소, 채널추정 오류의 극복에 미치는 영향을 분석한다. nature, in contrast to physical theories that are of a geometrical nature. An application to the interpretation of intelligence is proposed, based on the "intelligence"of movement. Co layer from 1.4 to 1.6 nm was measured to be ranged from 0.004 to 0.021 ${\AA}$$\^$-1/.문에 기업간 관계를 연구하는 측면에서는 탐험적 연구성격이 강하다. 더 나아가 본 산업의 주된 연구가 질적이고 기업내부만을 연구했던 것에 비교하면 시초적이라고 할 수 있다. 또한 관계마케팅, CRM 등의 이론적 배경이 되고 있는 신뢰와 결속의 중요성이 재확인하는 결과도 의의라고 할 수 있다. 그리고 신뢰는 양사 간의 상호관계에서 조성될 수 있는 특성을 가진 반면, 결속은 계약관계 초기단계에서 성문화하고 규정화 할 수 있는 변수의 성격이 강하다고 할 수가 있다. 본 연구는 복잡한 기업간 관계를 지나치게 협력적 측면에서만 규명했기 때문에 많은 측면을 간과할 가능성이 있다. 또한 방법론적으로 일방향의 시각만을 고려했고, 횡단적 조사를 통하고 국내의 한 서비스제공업체와 관련이 있는 컨텐츠 공급파트너만의 시각을 검증했기 때문에 해석에서 유의할 필요가 있다. 또한 타당성확보 노력을 기하였지만 측정도구 면에서 엄격한 개발과정을 준수하지는 못했다. 향후에는 모바일 컨텐츠 파트너의 기업의 특성을 조사하여 관계성 변수와의 상호관련연구를 진행할 필요가 있다. 관계기간, 의존성, 거래처의 단/복수여부, 서비스 범주 등의 제반 변수를 고려하여 이러한 변수가 양사와의 관계성 변수에 어떤 영향이 있는가를 검증할 필요가 있다. 또한 신뢰,

• The Korean Journal of Air & Space Law and Policy
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• v.19 no.1
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• pp.165-182
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• 2004

According to the Annex 17 to the Convention on International Civil Aviation, an appropriate authority of each contracting state has to define and allocate tasks and coordinate activities between the departments, agencies and other organizations of the State, airport and aircraft operators and other entities concerned with or responsible for the implementation of various aspects of the national civil aviation security programme. It is generally recognized that the three major parties responsible for the aviation security at an airport are appropriate government departments, airport operator and airlines. The airlines are the beneficiaries of security activities as well as the provider of security activities. So, their responsibilities have been critical in protecting civil aviation from unlawful interferences. The airport has to take leading role in implementing security tasks at airport area because the airport operator is the provider of airport facilities and services to its customer and the security activities belong to its services. The government has the responsibilities not only for establishing regulatory system but also for oversighting the implementation of aviation security activities. The paper is to review the revision of aviation security regulation and the changes of aviation security responsibilities, and costs and task assignment in Republic of Korea after September 11 event. The responsibilities, tasks and costs assigned to airlines, airport operators and government are introduced and evaluated in terms of economic fairness, effectiveness and efficiency of aviation security activities. The drawbacks of new legal system are pointed out and the suggestions to remedy them are proposed as conclusions.

• Journal of Environmental Impact Assessment
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• v.27 no.1
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• pp.17-32
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• 2018

The need for seawater desalination is increasing in terms of securing various water resources, but few studies are available as for the environmental impact of hypersaline concentrated water (brine) discharged from desalination plants. Domestic studies are concentrated mainly on toxicity evaluation that phytoplankton, zooplankton larvae and green algae (Ulva pertusa) are negatively affected by concentrated water. The mortality of Paralichthys olivaceus showed a linear relationship with increasing salinity, and Oryzias latipes died 100% at concentrations above 60 psu. Foreign studies included monitoring cases as well as toxicity evaluations. The number of species decreased around the area where the concentrated water discharged. The hypersaline concentrated water affects the pelagic and benthic organisms. However, the fishes escaped when exposed to salinity, and the pelagic and benthic organisms resistant to salinity survived the hypersaline environment. The salinity limit and distance from the outlet was presented as the regulatory standard for bine discharge. There were differences in regulatory standards among country and seawater desalination plants, and these regulatory standards have been strengthened recently. In particular, California Water Boards were revised to ensure that the maximum daily salinity concentration does not exceed 2 psu above the ambient salinity level within 100 m of the outlet.

• Journal of the Korean Society of Fisheries and Ocean Technology
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• v.35 no.2
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• pp.147-155
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• 1999

In this study, the stability analysis of a fishing vessel in a seaway was done. The stability analysis is an important item in the ship design, and so the ship registers of each nation constrain the ships to be followed the stability criterion. Stability variation, exciting forces due to wave and wind, and the broaching phenomena cause the capsizing of a ship. In this study, the stability analysis to study of the capsizing of a fishing vessel was performed. The relation between the speed of the ship and the wave length, that makes the encountering frequency vanish, was obtained. It was found that the encountering frequency tend to be zero when the wave whose length and direction are similar to those of ship. In this case, the possibility of dangerous situation becomes high. The calculated restoring arm becomes small when the ship is located near the wave crest. In general, the selected small fishing vessel is better than the large ship with respect to the stability, however the wave height becomes relatively high because of her small length Kim(l994) calculated the stability variation of the large cargo ship, the results of which showed the changes in stability great. But in the selected small fishing vessel in this study, the changes was small in comparison with the larger ship. This reason seems to be the shape of her midship section. In large cargo ships, the block coefficient is large, but that of the fishing vessel is relatively small and the small fishing vessel has chine, therefore the center of buoyancy moves much when the ship is inclined. It is desirable that the dynamic stability analysis for a fishing vessel, whose speed and direction are similar to those of waves, shall be done in the near future.