• 한국전자통신학회논문지
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• 제17권5호
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• pp.745-758
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• 2022

지식정보 기반 사회로의 진입이 가속화 됨에 따라 유한 자원인 전파의 활용이 국민 생활과 산업 전반에 폭발적으로 확산되고 있다. 이에, 주파수 자원의 효율적 활용과 급변하는 전파기술 환경변화에 조응하는 시장친화적인 무선국 관리제도의 중장기적 대안 마련 필요하다. 본 연구는 이동통신 무선국 허가 및 사후관리 제도 개선방안 제안을 위해 국내외 법령·제도를 문헌 조사 분석하여 무선국 포괄면허제도와 전파품질 자율규제 제도 도입 및 무선국 검사제도 개선안을 제안하였다. 본 연구를 통해 전파품질의 관리와 사업자의 자율권을 부여하는 전파관리 규제개선을 위한 법 개정 및 시행방안을 제공하는데 의의를 가진다.

• 한국항행학회논문지
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• 제17권6호
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• pp.765-776
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• 2013

민수용 항공기 산업에서는 해당 제품의 성능이 우수 하더라도 항공기의 항행 안전성을 확보하기 위하여 필요한 안전성 요구사항에 대한 적합성을 인정을 받지 못하면 법적으로 항공기에 사용 될 수 없는 특성이 있다 [1]. 이와 같이 다양하게 적용되어 지고 있는 항공 전자장비의 항행 안전성을 위하여 민간용 항공기에는 기술표준품 인증 제도를 시행하고 있다. KTSO-C113은 항공기용 다목적 전자식 디스플레이의 기술표준품을 인증하는 최소성능표준을 포함하고 있다. 기술 표준품 형식승인은 설계 및 제조에 대한 승인을 의미하여 항공기 장착하여 사용하기 위해서는 별도의 승인이 필요하다. 본 논문을 통하여 항공기용 다목적 디스플레이의 기술 표준품 형식승인 제도 및 인증 요구조건을 소개하고 적합성 입증을 위한 인증 사례를 제시한다.

• 시스템엔지니어링학술지
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• 제9권2호
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• pp.69-82
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• 2013

US DoD operated JCIDS(Joint Capability Integration and Development System) for top down requirement generation. Although the JCIDS can be a good practice for the countries which are trying to shift from bottom up to top down requirement generation, it contains many processes related with review and approval. In this study we structured a joint capability integration and development process from the JCIDS eliminating the organization dependent review or approval process so that it can be applied to any organization with some modification. Furthermore we implemented the process in the computer aided systems engineering tool, Cradle, for convenient use of the process. The result of this study can provide a basic process for top down capability development, and an efficient why of doing each element of the process using CASE tool.

• 대한의사협회지
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• 제61권12호
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• pp.765-775
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• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

• 한국중재학회지:중재연구
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• 제30권2호
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• pp.121-144
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• 2020

If the interim disposition of the Arbitration Tribunal is not immediately enforceable, it will only give pressure to the other party concerned and the arbitration could work against him if the other party fails to implement it. If enforcement is impossible, the disposition will have no practical effect or practical benefit. In addition, if a system is contrary to its unique characteristics or nature, it will not function as a system or it will become an unnecessary decoration. There is no room for argument that the above provisions are wrong or misinterpreted if the temporary disposition in arbitration cannot be characterized by its characteristics, such as its provisionality, urgency, incidentality, or invasibility. As attracting international arbitration cases can create enormous added value for the national economy, countries are scrambling to create a mediating-friendly legal environment in their countries, and Korea has been more active in arbitration than in the past. Despite various efforts, however, attracting international arbitration cases is still a long way off. Therefore, Korea should create a mediating-friendly, legal environment to attract arbitration cases. There are many reasons why arbitration is activated internationally, but the most important of them is that it is easier to approve and execute. The use of the approval and execution of heavy court is, in turn, the most important requirement of a mediating-friendly environment. It is natural that temporary dispositions made in arbitration should be as easy to approve and enforce as in the case of arbitration. In addition, it is natural for the parties to consider the use of approval and execution when deciding where to mediate or when applying for arbitration; thus, the degree of ease of execution, along with the procedural use of arbitration or provisional disposition, will be a measure of the likelihood of hosting international arbitration cases, as well as the activation of arbitration.

• 한국임상약학회지
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• 제21권1호
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• pp.22-29
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• 2011

Purpose: This study aims to investigate how gender-based differences are actually reflected on drug approval. Methods: Data on gender-based differences of drugs were analyzed by searching PDR (Physician's Desk Reference) with the keyword, "GENDER". Results: There were descriptions related to gender in product directions of 361 drugs in 2009 PDR, out of which 63 items actually showed gender-related differences. Drug categories showing comparatively high gender-based differences were nervous system, cardiovascular system, and alimentary tract and metabolism. Pharmacokinetic differences between genders were observed most frequently; compared to men, 32 drugs showed higher absorption while 18 drugs revealed lower clearance in women. There were 2 drugs which gender should be considered before prescribing, and 5 drugs which showed different severity of adverse effects according to gender. Conclusions: It is necessary to establish domestic policies for drug approval and use which reflects gender-based differences through sufficient researches.

• 한국융합학회논문지
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• 제8권8호
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• pp.59-69
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• 2017

인문 사회과학 연구원들과 데이터베이스 전문가들이 태평양문제연구회(IPR)가 작성한 IPR 자료를 데이터베이스로 구축하기 위해 함께 하였다. 본 논문은 그 데이터베이스의 구축에서 IPR 자료의 품질을 보장하기 위한 쟁점과 해결책을 제시한다. 우리는 데이터베이스의 접근성을 위해 웹에 데이터베이스를 유지하여 연구원들이 웹 브라우저로 접근할 수 있도록 하며, 데이터베이스 구축의 편리성을 위해 통합 인터페이스를 제공하여 연구원들이 그 속에서 모든 작업을 수행하게 하며, 구축한 IPR 자료의 완전성을 위해 입력된 각 IPR 자료의 책임 소재를 밝히는 책임 입력과 책임 승인을 지원하며, 승인의 즉시성을 위해 연구원들의 입력을 원활히 하는 대화형 승인 과정을 지원한다. 또한 구축한 IPR 자료의 정확성을 보장하기 위해 우리는 데이터베이스 설계, 질의 처리, 트랜잭션 관리, 검색과 정렬 기법들을 사용한다. 특히, 레코드들 간의 존재 종속관계를 이용한 동시성 제어를 통하여 운영체제 파일과 그 파일의 경로 간의 정확성을 보장한다. 향후 연구로 내용 검색, 데이터베이스의 다운로드와 업로드, IPR 자료의 저작권 관련 작업을 포함한다.

• 한국작물학회지
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• 제23권3호
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• pp.16-18
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• 1978

Recently consumption of agrochemicals rapidly increased with the demand for higher crop productivity. With this trend the role of government control over the field efficiency and safety aspects of pesticide use became more important. The government reformed the pesticides approval and management scheme in 1977. The new act became effective from April 1 1978. This paper introduces the contents of new act and the methods of herbicide registration trial

• 한국임상약학회지
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• 제32권3호
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• Biomolecules & Therapeutics
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• 제23권6호
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• pp.493-509
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• 2015

Antibody-drug conjugates utilize the antibody as a delivery vehicle for highly potent cytotoxic molecules with specificity for tumor-associated antigens for cancer therapy. Critical parameters that govern successful antibody-drug conjugate development for clinical use include the selection of the tumor target antigen, the antibody against the target, the cytotoxic molecule, the linker bridging the cytotoxic molecule and the antibody, and the conjugation chemistry used for the attachment of the cytotoxic molecule to the antibody. Advancements in these core antibody-drug conjugate technology are reflected by recent approval of Adectris$^{(R)}$(anti-CD30-drug conjugate) and Kadcyla$^{(R)}$(anti-HER2 drug conjugate). The potential approval of an anti-CD22 conjugate and promising new clinical data for anti-CD19 and anti-CD33 conjugates are additional advancements. Enrichment of antibody-drug conjugates with newly developed potent cytotoxic molecules and linkers are also in the pipeline for various tumor targets. However, the complexity of antibody-drug conjugate components, conjugation methods, and off-target toxicities still pose challenges for the strategic design of antibody-drug conjugates to achieve their fullest therapeutic potential. This review will discuss the emergence of clinical antibody-drug conjugates, current trends in optimization strategies, and recent study results for antibody-drug conjugates that have incorporated the latest optimization strategies. Future challenges and perspectives toward making antibody-drug conjugates more amendable for broader disease indications are also discussed.