• Title/Summary/Keyword: Licensing issue

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SCALING ANALYSIS IN BEPU LICENSING OF LWR

  • D'auria, Francesco;Lanfredini, Marco;Muellner, Nikolaus
    • Nuclear Engineering and Technology
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    • v.44 no.6
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    • pp.611-622
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    • 2012
  • "Scaling" plays an important role for safety analyses in the licensing of water cooled nuclear power reactors. Accident analyses, a sub set of safety analyses, is mostly based on nuclear reactor system thermal hydraulics, and therefore based on an adequate experimental data base, and in recent licensing applications, on best estimate computer code calculations. In the field of nuclear reactor technology, only a small set of the needed experiments can be executed at a nuclear power plant; the major part of experiments, either because of economics or because of safety concerns, has to be executed at reduced scale facilities. How to address the scaling issue has been the subject of numerous investigations in the past few decades (a lot of work has been performed in the 80thies and 90thies of the last century), and is still the focus of many scientific studies. The present paper proposes a "roadmap" to scaling. Key elements are the "scaling-pyramid", related "scaling bridges" and a logical path across scaling achievements (which constitute the "scaling puzzle"). The objective is addressing the scaling issue when demonstrating the applicability of the system codes, the "key-to-scaling", in the licensing process of a nuclear power plant. The proposed "road map to scaling" aims at solving the "scaling puzzle", by introducing a unified approach to the problem.

Determine Optimal Timing for Out-Licensing of New Drugs in the Aspect of Biotech (신약의 기술이전 최적시기 결정 문제 - 바이오텍의 측면에서)

  • Na, Byungsoo;Kim, Jaeyoung
    • Knowledge Management Research
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    • v.21 no.3
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    • pp.105-121
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    • 2020
  • With regard to the development of new drugs, what is most important for a Korean Biotech, where no global sales network has been established, is decision-making related to out-licensing of new drugs. The probability of success for each clinical phase is different, and the licensing amount and its royalty vary depending on which clinical phase the licensing contract is made. Due to the nature of such a licensing contract and Biotech's weak financial status, it is a very important decision-making issue for a Biotech to determine when to license out to a Big Pharma. This study defined a model called 'optimal timing for out-licensing of new drugs' and the results were derived from the decision tree analysis. As a case study, we applied to a Biotech in Korea, which is conducting FDA global clinical trials for a first-in-class new drug. Assuming that the market size and expected market penetration rate of the target disease are known, it has been shown that out-licensing after phase 1 or phase 2 of clinical trials is a best alternative that maximizes Biotech's profits. This study can provide a conceptual framework for the use of management science methodologies in pharmaceutical fields, thus laying the foundation for knowledge and research on out-licensing of new drugs.

A Study on the Application for Domestic Remote Operator Licensing System for Maritime Autonomous Surface Ships Using the AHP (AHP를 활용한 자율운항선박 원격운영자의 국내 면허체계 적용방안에 관한 연구)

  • HanKyu PARK;MinJae HA
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.29 no.6
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    • pp.628-638
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    • 2023
  • Maritime Autonomous Surface ships(MASS) are gradually gaining importance. Until fully autonomous ships are developed, they will likely be controlled by remote operators who are based in a Remote Operations Center. However, there is currently no internationally or domestically established licensing for them. This issue can potentially pose a risk to navigation safety due to operations being handled by unqualified remote operators. We conducted a literature review and proposed criteria for the adoption of a licensing system for remote operators. We have futher offered alternatives to integrate this license into the existing officer licensing system, and analyzed them using Analytic Hierarchy Process(AHP). Subsequently,, theprimary need to enact legislation for remote operators is observed. The most preferred approach is to include the occupation of a remote operator in the Ship Officer Act, Article 4: Occupational Categories and Class of Licenses. Therefore, it would be logical for the organizational structure of the Remote Operation Center to mirror the traditional Bridge Resource Management. This study will contribute to the efficient training of remote operators and the safe navigation of autonomous ships with a focus on human resource management.

Development of a design issue management system(DIMS) for human factors engineering in nuclear power plants (원자력발전소의 인간공학 설계 지원을 위한 설계 현안 관리 시스템(DIMS) 개발)

  • 이용희;정광태
    • Journal of the Ergonomics Society of Korea
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    • v.16 no.3
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    • pp.77-87
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    • 1997
  • This paper describes the developement of a Design Issue Management System (DIMS). Although human factors engineering has been recognized as one of the critical activities in the design of man-machine system, it has been hardly successful nor effective in practice to cope with the hyman factors requirements by regulations. For supporting the human factors engineering in nuclear power plants, DIMS ahs three major modules : Design Requirements Data Base, Design Issue Tracking System, Issue Evaluation Support System. These modules function as formal verification architects that the licensing authority requests for verifying the safety of the equip- ment and facilities in nuclear power plants. An example application to an operator support system, named Critical Function Monitoring System, during its independent review of the human factors shows the usage and the benefit of DIMS.

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Remarks on Defining Korean NPIs in terms of Negation Strength

  • Shin, Keun-Young;Chung, Dae-Ho
    • Language and Information
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    • v.13 no.2
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    • pp.47-57
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    • 2009
  • It has been observed that not all negative polarity items (NPIs) are licensed in the same negative contexts, and different NPIs may be licensed by different negative expressions. This shows that Ladusaw's (1979) downward entailment is not precise enough to account for the distributional patterns of NPIs (van der Wouden, 1997; van der Wouden and Zwarts, 1993; Zwarts, 1986, among others). One well-known attempt to deal with this issue is to divide negative expressions into several subtypes. Using boolean semantics, Zwarts (1986; 1998) distinguishes three kinds of downward entailing licensors and accounts for heterogeneous NPI-licensing conditions by means of the semantic strength of negative expressions. This approach has been adopted to define Korean negation (Nam, 1994; Chung, 1993; Chung, 1997; Hwang, 2009). In this paper, however, we argue that the boolean semantic approach for negation is not adequate in characterizing the properties of Korean negative expressions and explaining the contexts of licensing Korean NPIs.

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Virtual Livestreamed Performance and E-License

  • Kim, Kyungsuk
    • International journal of advanced smart convergence
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    • v.9 no.3
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    • pp.78-84
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    • 2020
  • Due to social distancing caused by COVID 19, music concerts have not been allowed at home and abroad, and it is not known when overseas concerts will be able to resume unless the pandemics calm down, even if they are available. Meanwhile, people consume much more content through online services such as Netflix and YouTube than before. Under these circumstances, the music industry expects the virtual livestreamed performance to restore sluggish live performances again and bring about a digital renaissance. It also leads to the issue of reestablishing a copyright system regarding a livestreamed performance and of preparing a new rate of royalty standards for the use of works in OTT. In addition, a multi-territorial licensing of r ights in musical works is necessary to resolve copyright issues efficiently by applying the same term s to all countries from where the audience comes. In this paper, I examine the legal nature and the decision of copyright fees of performances as an integral part of the music industry.

Legal Issues on Hydrogen Bunkering through Domestic Law (국내 법령을 통한 수소 벙커링 도입의 법제도 쟁점)

  • YOUN, DONGHYUP;LEE, SANGICK;PARK, CHUNGHWAN
    • Transactions of the Korean hydrogen and new energy society
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    • v.33 no.2
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    • pp.142-147
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    • 2022
  • Along with the global discussion on climate change prevention, regulations on hazardous substances emitted from ships were also carried out. Batteries have been regularly proposed as a solution for transportation, but lack of energy density has presented hydrogen as a final alternative. This study conducted legal issues regarding the method of providing hydrogen fuel on land and providing hydrogen fuel at sea. It is necessary to study how to institutionalize hydrogen bunkering in the legal system of the licensing system and distribution system.

Corrosion Evaluation for Advanced Fuel Cycle Facilities (선진 핵연료주기 시설(AFC)의 부식건전성 조사, 분석)

  • Hwang, Seong Sik
    • Corrosion Science and Technology
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    • v.11 no.6
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    • pp.213-217
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    • 2012
  • The amount of spent fuel from nuclear power plants has been increasing. An effective management plan of the spent fuel becomes a critical issue, because the storage capacity of each plant will reach its storage limit in a few years. The volume of high toxic spent fuel can be reduced through a fuel processing. Advanced Fuel Cycle (AFC) system is considered to be one of the options to reduce the toxicity and volume of the spent fuel. It is necessary to set up a test facility to demonstrate the feasibility of the process at the engineering scale. The objective of the work is a development of the safety evaluation technology for the AFC system. The evaluation technology of the AFC structural integrity and processes were surveyed and reviewed. Key evaluation parameters for the main processes such as electrolytic reduction, electrorefining, and electrowinning were obtained. The survey results may be used for the establishment of the AFC regulatory licensing procedure. The establishment of the licensing criteria minimizes the trials and errors of the AFC facility design. Issues taken from the survey on the regulatory procedure and design safety features for the AFC facility provide a chance to resolve potential issues in advance.

Medical Education for North Korean Defector Physicians: Experience at the Seoul Medical Center (북한이탈의사 교육: 서울의료원에서의 경험을 중심으로)

  • Choi, Jae-Phil
    • Korean Medical Education Review
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    • v.14 no.2
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    • pp.95-101
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    • 2012
  • As North Korea passed from the Devotion (Jeongseong) movement to the black market (Jangmadang) system, the medical service system in that country was effectively destroyed. North Korean physicians who have successfully defected to South Korea (North Korean defector physicians, NKDPs) have experienced socio-economic hardships on their way to becoming incorporated into the South Korean medical system due to different medico- social cultures, different (English-based) medical terminology, and the clinical knowledge gap between North and South Korea. Since 2009, we have operated programs at the Seoul Medical Center to help NKDPs prepare for the South Korean medical licensing examination. These programs consist of clinical education at the medical center, personal mentoring, arrangement of educational programs at the medical college, mock tests at the consortium, and administrative aid. Looking forward, we hope to achieve the following: 1) More systematic support plans are needed involving medical education experts, field physicians, and experts on reunification. 2) An evaluation of defector physicians' current medical knowledge may provide information about the areas where supplementary education is most needed and the standards for certificating licenses. 3) In the short term, a customized glossary should be developed to assist defector physicians prepare for the examination. 4) To secure internships and residencies is the most important issue for further sustained training of NKDP physicians to become good clinicians after certification. Hopefully, this short report on the current ongoing educational course will lead to more extensive discussion.

Historical Transition and Future Task of Pharmacist License Examination in Korea (우리나라 약사면허 국가시험제도 변천과정과 향후과제)

  • Yoo, Bong Kyu
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.2
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    • pp.71-79
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    • 2014
  • Objectives of this study are to investigate transition history of pharmacist license examination in Korea and to compare three suggestions for new examination system proposed by National Health Personnel Licensing Examination Board, Korean Association of Pharmacy Education, and Korean Pharmaceutical Association. Future task to help the examination system meet global standard is also discussed. Regulations on the examination system were retrieved from the sources posted in Ministry of Government Legislation homepage. Efforts devoted by the three organizations to make amendment on the regulations were collected from reports, official documents, minutes, and handout materials issued by the organizations. Ministry of Health and Welfare made amendment on the examination system in 2013 by rearranging the existing natural science-based eleven subjects to two subjects along with addition of a new subject named clinical-practical pharmacy. Unfortunately, however, the amendment stipulates that the new subject should include manufacturing and quality control of pharmaceuticals as part of contents in the examination. It is strongly urged that the contents of the examination should focus on professional competency as pharmacist in clinical situation. Future task to make revision on this issue is warranted to help new pharmacist enable to provide pharmaceutical care service to patients.