• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Nuclear Engineering and Technology
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• 제49권2호
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• pp.426-433
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• 2017

This paper describes the development process, the innovative techniques used and insights gained from the latest integrated, full scope, multistate Level 2 PSA analysis conducted at the Leibstadt Nuclear Power Plant (KKL), Switzerland. KKL is a modern single-unit General Electric Boiling Water Reactor (BWR/6) with Mark III Containment, and a power output of $3600MW_{th}/1200MW_e$, the highest among the five operating reactors in Switzerland. A Level 2 Probabilistic Safety Assessment (PSA) analyses accident phenomena in nuclear power plants, identifies ways in which radioactive releases from plants can occur and estimates release pathways, magnitude and frequency. This paper attempts to give an overview of the advanced modeling techniques that have been developed and implemented for the recent KKL Level 2 PSA update, with the aim of systematizing the analysis and modeling processes, as well as complying with the relatively prescriptive Swiss requirements for PSA. The analysis provides significant insights into the absolute and relative importances of risk contributors and accident prevention and mitigation measures. Thanks to several newly developed techniques and an integrated approach, the KKL Level 2 PSA report exhibits a high degree of reviewability and maintainability, and transparently highlights the most important risk contributors to Large Early Release Frequency (LERF) with respect to initiating events, components, operator actions or seismic component failure probabilities (fragilities).

• Archives of Plastic Surgery
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• 제39권6호
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• pp.585-592
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• 2012

During the past decade, many studies using platelet-rich plasma (PRP) or adipose-derived stem cells (ASCs) have been conducted in various medical fields, from cardiovascular research to applications for corneal diseases. Nonetheless, there are several limitations of practical applications of PRP and ASCs. Most reports of PRP are anecdotal and few include controls to determine the specific role of PRP. There is little consensus regarding PRP production and characterization. Some have reported the development of an antibody to bovine thrombin, which was the initiator of platelet activation. In the case of ASCs, good manufacturing practices are needed for the production of clinical-grade human stem cells, and in vitro expansion of ASCs requires approval of the Korea Food and Drug Administration, such that considerable expense and time are required. Additionally, some have reported that ASCs could have a potential risk of transformation to malignant cells. Therefore, the authors tried to investigate the latest research on the efficacy and safety of PRP and ASCs and report on the current state and regulation of these stem cell-based therapies.

• 해양환경안전학회지
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• 제24권6호
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• pp.717-725
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• 2018

IMO는 해사안전 및 환경보호와 관련된 IMO 국제협약의 효과적인 적용을 위해 자발적 회원국감사 제도를 개발하여 '06년부터 '15년까지 시행해 왔다. 이를 통해 IMO 회원국 감사제도의 목적 및 절차 등을 시범적으로 적용하였고 개선점을 식별하여 2016년 1월 1일부터 강제적 회원국 감사제도(IMSAS)를 시행하게 되었다. IMSAS는 IMO 협약을 비준한 IMO 회원국 중에 기국, 연안국 및 항만국으로서 주어진 책임을 적절히 수행하고 있는지 확인하여 식별된 사항의 개선을 통해 IMO 국제협약의 효과적인 적용을 위해 시행되었다. 본 연구에서는 2020년 예정된 대한민국의 IMSAS 감사에 대비하기 위해서 IMO 문서를 참조하여 IMSAS의 내용 및 절차에 대해서 확인하였다. 더불어 과거 대한민국의 VIMSAS 수검 결과, 타국의 VIMSAS 수검 시 주요한 지적 사항 및 2018년 IMO III 5차 회의에 제출된 첫 IMSAS 수검 통합 결과 보고서에 대한 분석을 바탕으로 대한민국의 원활한 IMSAS 수검을 위해 해양수산부훈령의 최신화, IMO 협약에 의해 요구되는 정보 보고사항의 모니터링을 위한 시스템 개발, 전문가 지정, 관련 법령의 영문화, IMSAS 감사관 양성 및 IMSAS 수검 대응 조직구성을 제안하였다.