• 약학회지
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• 제52권2호
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• pp.151-159
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• 2008

Consultation program for pharmaceutical development is a new system in which pharmaceutical companies meet and discuss scientific and/or regulatory issues with drug regulatory authority in the research process and before submitting new drug applications. This program helps pharmaceutical companies reduce uncertainties in the research and development and increase the possibilities of getting drug marketing approval. Developed countries such as US, EU, and Japan have implemented various forms of pre-submission meetings or consultation programs since the mid-1990s. The rapid development of technology in pharmaceutical R&D increases the importance of communication between drug development companies and drug regulatory authority in Korea, too. In designing the consultation program, it is desirable to focus on the stages of clinical trials which take the longest period of time and the biggest amount of money in the pharmaceutical R&D process. We suggested that results or recommendations by drug regulatory authorities in pre-submission meetings or consultations be formally documented and considered in review process. Explicit scientific reasons are required for changing the results from consultations.

• 국제학술발표논문집
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• The 9th International Conference on Construction Engineering and Project Management
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• pp.67-73
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• 2022

Construction bid documents contain various errors or discrepancies giving rise to uncertainties. The errors/discrepancies/ambiguities in the bid document, if not identified and clarified before the bid, may cause dispute and conflict between the contracting parties. Given the fact that bid document is a major resource in estimating construction costs, inaccurate information in bid document can result in over/under estimating. Thus, any questions from bidders related to the errors in the bid document should be clarified by employers before bid submission. This study aims to examine the pre-bid queries, i.e., pre-bid request for information (RFI), from state DoTs of the United States to investigate error types most frequently encountered in bid documents. For the study, around 200 pre-bids RFI were collected from state DoTs and were classified into several error types (e.g., coordination error, errors in drawings). The analysis of the data showed that errors in bill of quantities is the most frequent error in the bid documents followed by errors in drawing. The study findings addressed uncertainty types in construction bid documents that should be checked during a bid process, and, in a broader sense, it will contribute to advancing the construction management body of knowledge by clarifying and classifying bid risk factors at an early stage of construction projects.

• 한국항공운항학회지
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• 제21권2호
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• pp.62-69
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• 2013

The introduction of aviation into the EU-ETS has faced significant opposition from many ICAO member States. Accordingly a global solution through ICAO is in progress. This paper traces the progress of works done by the HGCC in the area of global aviation aspiration goals aiming for the submission to the 38th Session of the ICAO Assembly. Furthermore, devices for calculating the carbon dioxide emissions from flights have been developed by several agencies including international organizations, governments, airlines and nongovernmental organizations. These carbon calculators, however, introduce too many assumptions to simplify the calculation process. This study assesses carbon calculators for aviation emissions and suggests a modified calculation methodology using the pre-existing computer reservation system for better accuracy.

• 대한한의학회지
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• 제41권1호
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• pp.21-44
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• 2020

Objectives: This study was aimed to develop a pharmacovigilance practice training course for future doctors of Korean medicine, the graduate students of a college of Korean medicine, and to verify the educational effect of the curriculum. Methods: Fifty-six students were given a training course designed as follows: 1) pre-class homework (basic theory self-study, online course, causality assessment, and adverse event reporting simulation); 2) in-class: homework submission and case discussion; 3) after-class: homework revision and resubmission. An online survey to assess the change of the level of basic knowledge and attitudes toward pharmacovigilance, the willingness to report adverse events, and self-efficacy for the causality assessment and adverse event reporting was conducted before and after education. Results: The survey participation rate was 96.5% in pre-education and 64.3% in the post-education survey. After education, knowledge level was improved (mean score from 4.3±2.11 to 6.7±1.96 points, modal value from 3 to 8 points) and positive changes were observed in almost all questions on attitudes. In the post-education survey, more students felt that they could do causality assessment (from 13% to 80.5%), could report adverse events to the agency in charge (from 7.4% to 96.2%), and expressed their strong willingness to report adverse events in the future (from 77.8% to 88.9%) than in the pre-education survey. Conclusions: More schools of Korean medicine need to adopt pharmacovigilance training courses in their curriculum to foster future doctors of Korean medicine with pharmacovigilance capabilities. Such efforts will be the basis for achieving an evidence-based, safe use of herbal medicine.

• 한국콘텐츠학회:학술대회논문집
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• 한국콘텐츠학회 2006년도 추계 종합학술대회 논문집
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• pp.584-588
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• 2006

최근 컨퍼런스는 지속적으로 늘어가고 이에 따른 홍보 및 관리비용도 증가하고 있다. 따라서 소규모 학회에서 컨퍼런스 등록이나 홍보 등의 서비스를 제공하기 위한 비용과 관리적인 부담이 크다. 따라서 본 논문에서는 소규모 학술대회 및 컨퍼런스에서 홍보 및 등록 비용을 최소화하기 위해 인터넷 상에서 컨퍼런스에 등록하고 홍보하는 웹 기반의 도구를 설계하고 구현한다. 즉, 다양한 학회 정보를 수용할 수 있도록 데이터베이스를 구축하고 운영관리자가 쉽게 컨퍼런스 정보를 관리할 수 있는 툴과 자동 생성되는 홈페이지를 설계 및 구현한다. 이러한 도구는 컨퍼런스를 개최하고자 하는 학회에서 컨퍼런스 등록 및 홍보 서비스 시스템에 컨퍼런스에 대한 기본적인 정보를 입력하면 그에 해당하는 웹사이트가 생성되고 논문 투고 및 사전 등록, 홍보 메일 발송 서비스를 제공한다.

• 한국중재학회지:중재연구
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• 제28권2호
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• pp.91-110
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• 2018

Consumers repeatedly make small sum purchases through business-to-consumer contracts, usually without incident. Consumer areas have been increasing; therefore, consumer disputes have been occurring frequently as well. In international consumer transactions, it is not easy to solve consumer disputes by applying the laws of different countries. Resolving disputes by using the consumer arbitration system can be a measure to protect consumers. In the U.S., a class arbitration is being operated as a mixed dispute resolution system of class action and arbitration. Consumer Arbitration has long been a controversial issue in the U.S. It is therefore a lesson for us to examine related cases. A recent U.S. Supreme Court decision, DIRECTV v. Imburgia, was looked into and after a summary of the facts, issues, and opinions and opposing opinions that had a tight controversy, a close analysis was done. The analysis through this judgment is as follows: first, the contraction of consumer protection; second, the expansion of the Federal Arbitration Act scope; third, the class arbitration's restriction; and fourth, the submission of the arbitration fairness act.

• 약학회지
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• 제57권6호
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• pp.432-441
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• 2013

It's been almost 20 years since the adoption of Good Manufacturing Practices (GMP) in Korea since 1994. There have been big progresses in the GMP regulations and its implementations. 'New GMP' in 2008 has adopted validation, pre-approval GMP evaluation, annual quality review, etc.. Upon the submission of PIC/S (Pharmaceutical Inspection Cooperation Scheme) application by Korea's Ministry of Food and Drug Safety in April, 2012, Korea is facing new opportunity to level up Korea GMP regulations. As such, this study suggested GMP revision points by comparing and analyzing the differences between PIC/S GMP and Korea GMP. Those areas which GMP is not required such as radiopharmaceuticals and medical gases should adopt GMP. And independent GMP regulation is needed for Active Pharmaceutical Ingredients and investigational medicinal products. Also, those regulations shall be implemented in the higher level of legal status. Finally, rather than pursuing GMP harmonization only for PIC/S membership, GMP improvement in the long term shall be taken into consideration by reflecting current quality issues such as ICH Q8 (Pharmaceutical development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).

• Nuclear Engineering and Technology
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• 제53권10호
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• pp.3449-3459
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• 2021

With the increasing availability of high-performance computing (HPC) platforms, uncertainty quantification (UQ) and sensitivity analyses (SA) can be efficiently leveraged to optimize design parameters of complex engineering problems using modeling and simulation tools. The workflow involved in such studies heavily relies on HPC resources and hence requires pre-processing and post-processing capabilities of large amounts of data along with remote submission capabilities. The NEAMS Workbench addresses all aspects of the workflows involved in these studies by relying on a user-friendly graphical user interface and a python application program interface. This paper highlights the NEAMS Workbench capabilities by presenting a semiautomated coupling scheme between Dakota and any given package integrated with the NEAMS Workbench, yielding a simplified workflow for users. This new capability is demonstrated by running a SA of a turbulent flow in a pipe using the open-source Nek5000 CFD code. A total of 54 jobs were run on a HPC platform using the remote capabilities of the NEAMS Workbench. The results demonstrate that the semiautomated coupling scheme involving Dakota can be efficiently used for UQ and SA while keeping scripting tasks to a minimum for users. All input and output files used in this work are available in https://code.ornl.gov/neams-workbench/dakota-nek5000-study.