• 한국지리정보학회지
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• 제14권3호
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• pp.1-10
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• 2011

본 프로그램 개발의 목적은 기존의 아날로그 형태의 제작과정 및 공정 그리고 방대한 자료 관리의 문제점들을 해결하기 위해 SDE(spatial database engine) 라는 공간DB엔진을 이용하여 대량의 임상도를 운영 관리하는데 있다. 이를 위해 공간DB검색, 작업내용 및 진도파악, 인접 도엽간 검정/편집, 완료 도엽의 승인 및 반려 기능 등을 구현하여 일관된 운영 관리 표준화 공정을 확립하였다. 향후 본 프로그램을 활용하여 효율적인 임상도 제작과 대량의 임상도 보급이 가능할 것이며, 이에 따른 시간 및 비용을 절감할 수 있을 것으로 기대된다.

• 한국임상약학회지
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• 제16권2호
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• pp.107-112
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• 2006

This study was aimed to investigate the current status and expectations of orphan drugs in Korea. The Korea Orphan Drug Center was established to supply many medicines for the patients with rare diseases. Among the medicines supplied by the Center, the number designated as the orphan drugs by the KFDA is quite few. However, a few of medicines are not under circulation even if the items are designated as the orphan drugs. Neoplasm-related medicines, infectious and parasitic disease-related medicines, endocrine, nutritional and metabolic disease-related medicines are the ones circulated most. There are several unapproved drugs among the medicines supplied by the Center. It's because the director of the Center can import the goods without a process to getting an approval from the KFDA. The Korea Orphan Drug Center has contributed to the selection of the medicines for treating the rare disease. On the contrary, some problems remain in the supply process. The safety and effectiveness of the medicines supplied by the Center are not guaranteed. So far, rare diseases have no specific legal definition, and therefore are only referred to in terms of the population of patients, which prevent from establishing the range of medicines. The introduction of Special Access Program or Access to Unapproved Therapeutic Goods will be the solution of these problems. In addition, it is another solution to keep intimate relations with the Rare and Intractable Disease Center and the Medicine Safety Information Center which will be open soon.

• 무역상무연구
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• 제69권
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• pp.523-541
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• 2016

According to Chinese Arbitration Law, combination of mediation with arbitration means that in the process of arbitration, arbitrator may conduct mediation proceedings for the case they are handling, provided both parties agree to do so. If mediation succeeds and the parties reach a settlement agreement, the arbitrators may render a consent award or a written mediation statement in accordance with the contents of the settlement agreement. If mediation fails, the arbitration proceedings will be resumed until the case is concluded by making of an arbitral award. There is no formal name of this system in China, it is called "combination of mediation with arbitration", "mediation in arbitration process" or "arbitration-mediation", the author of this thesis select "arbitration-mediation" and make it simply as "Arb-Med". This thesis concentrates on three issues that arbitrators and the parties have to clarify and pay attention to once they choose to use Arb-Med. The first part is about the 'waivable problems', include waive the right to challenge a arbitrator who act as a mediator at the same time with parties' approval, as well as the question about the waiver of the arbitrator's duty to disclose confidential information obtained during mediation. The second part is 'public policy in Arb-Med', introduces the concept of public policy, the bias may arise the complaint about public policy, and the due procedure problem. And the last part is about the award deals with a difference not contemplated by or not falling within the terms of the submission to arbitration, or it contains decisions on matters beyond the scope of the submission to arbitration, especially about the award including some contents which has relation to third party's interests.

• 대한한의학원전학회지
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• 제27권4호
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• 한국수산과학회지
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• 제29권6호
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• pp.900-908
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• 1996

Changes of paralytic shellfish toxin components and specific toxicity in blue mussel, Mytilus edu/is and oyster, Crassostrea gigas during canning process were investigated by high performance liquid chromatography (HPLC). The $mole\%$ of the frozen shucked blue mussel were in order of $27.5\;mole\%$ of gonyautoxin 1, $23.0\;mole\%$ of gonyautoxin 8 (C1) and $23.0\;mole\%$ of epi-gonyautoxin 8 (C2), while those of the frozen shucked oyster were in order of $29\;mole\%$ of C1, $22\;mole\%$ of C2, $16.7\;mole\%$ of gonyautoxin 2. Both samples had minor amounts of saxitoxin and neosaxitoxin. On the other hand, in case of specific toxicity, the major toxins were consisted of gonyautoxin $1\~4$ in both sample. The toxicity of gonyautoxin $1\~4$ were 88 and $84\%$ in blue mussel and oyster, respectively. According to the experimental results, C1, C2 and gonyautoxin 4 were very sensitive to heat treatment, while gonyautoxin 2 and saxitoxin were pretty heat resistant than any other toxin components.

• 한국콘텐츠학회논문지
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• 제12권7호
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• pp.156-168
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• 2012

최근에 강도, 살인, 강간 등 강력범죄의 발생이 사회적 문제로 대두되면서, 추가적인 범죄피해의 예방과 국민의 알권리의 보장을 위해 범죄인에 대한 신상공개제도를 입법화하고 이를 확대하려는 경향이 대두되고 있다. 이러한 분위기는 재판절차를 통해 형이 확정되지 아니한 특정 범죄의 피의자의 얼굴 등 신상을 수사단계에서 공개하는 입법을 가능하게 하여, 피의자의 얼굴 공개를 허용하는 것을 뼈대로 한 '특정강력범죄 처벌에 관한 특례법 개정안'이 2010년 4월 국회에서 통과되었다. 그러나 특정 강력범죄에 대한 신상공개가 범죄피해의 예방에 큰 효과가 있다는 사실이 경험적으로 확인된 바가 없을 뿐만 아니라, 법원의 판결이 있기도 전에 피의자의 신상정보가 언론에 공개됨으로써 헌법이 보장하고 있는 피의자의 프라이버시나 인격권 및 공정한 재판을 권리와 같은 기본권을 침해하는 것일 뿐만 아니라, 헌법상 무죄추정의 원칙, 적법절차의 원칙, 이중처벌금지의 원칙(일사부재리의 원칙), 명확성의 원칙, 과잉금지의 원칙에도 위배되고, 형법상 책임원칙에도 위배된다 할 것이다.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.229-254
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• 2004

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

• 한국기록관리학회지
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• 제20권3호
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• pp.1-21
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• 2020

국가기록원은 2015년부터 보존기간 30년 이상의 표준 전자문서를 중앙행정기관으로부터 이관 받고 있다. 이 과정에서 다양한 종류의 오류와 비효율이 발견되었으나, 그 오류원인을 분석하고 문제해결을 위한 연구는 없었다. 본 연구를 통하여 이관 시 발견되는 대부분의 오류가 생산단계에서 발생하는 것을 확인하고, 이를 해결하기 위한 4가지 방안을 제안한다. 첫째, 전자문서를 결재하기 전에 본문 및 첨부 파일의 결함을 체크하여 오류를 사전에 방지한다. 둘째, 결재와 동시에 전자파일 단위로 전자지문을 생성 및 관리하여 무결성을 보장한다. 셋째, 이관 및 보존 과정에 전자지문 비교·확인 및 결함체크 절차를 적용하여 자동으로 무결성 검증 및 이관 검수를 수행한다. 넷째, 기록화 대상 기준 및 무결성 보장 기술 등이 생산단계에 제대로 적용되는지 관리 및 감독한다.

• 환경정책연구
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• 제9권1호
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• pp.3-29
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• 2010

기후변화에 따른 광역적 토지사용 정책의 중요성에 대해 미국 캘리포니아 사례를 분석하여 제시하였다. 미국 연방제 하에서 각 주정부의 고유한 환경정책은 온실가스를 줄이는 데 주요한 역할을 하고 있다. 미국 캘리포니아주의 SB 375 입법 사례와 법안에 포함된 인센티브 제도는 실제적으로 토지사용, 교통, 주택 등에 어떠한 정책적 영향을 끼칠 수 있는지 모델을 제시하고 있다. 또한 한국에서의 녹생성장의 논의에 있어서 기후변화에 대처한 환경정책과 광역개발정책의 적절한 통합에 대한 정책적 시사점을 제시하고 있다. 캘리포니아 주정부의 SB 375는 캘리포니아 기후변화정책의 실제적 집행전략으로서: 1) 교통계획 시 지속 가능한 커뮤니티 전략 도입 2) 광역계획과 주택정책의 통합 3) 구체적인 인센티브 도입 4) 온실가스를 줄이는 전략 도입 5) 캘리포니아 대기관리국의 역할 등을 제시하고 있다.

• 한국산업융합학회 논문집
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• 제24권6_2호
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• pp.899-908
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• 2021

It is expected that the global market for vessel repair and remodeling will grow up to the scale of about 25 billion dollars by 2023. Korea's shipbuilding industry is leading the world with its international competitiveness in design and production technology. The actual status of vessel repair industry, however, is poor as there are only two or three companies for vessel repair that can deal with large vessels in the area of Gyeongnam. The reason is that civil complaints are filed severely about environmental problems and environment-related regulations are so strict that it is fairly hard to get governmental approval for the operation of a vessel repair workplace. Domestic vessel repair companies mainly target small- and medium-sized vessels. There are only few workplaces that can carry out regular examination or repair work on large vessels such as LNG vessels, and due to the high price of vessel repair, most of the domestic repair work on large vessels including LNG vessels tends to be snatched by markets in Southeast Asia or China. Despite the tremendous domestic demand of Korea that has established the world's first shipbuilding industry and world's sixth biggest harbor infrastructure, its vessel repair industry can be said to be in very poor condition. In order to vitalize vessel repair industry, this study is aimed to analyze the environmental influence of vessel repair workplaces in Gyeongnam where vessel repair companies are concentrated and suggest standard processes by analyzing vessel repair processes precisely.