• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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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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• v.49 no.2
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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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• v.39 no.6
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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.

• Journal of the Korean Society of Marine Environment & Safety
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• v.24 no.6
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• pp.717-725
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• 2018

IMO developed VIMSAS for effective application of IMO instruments related to maritime safety and environmental protection and was implemented from 2006 to 2016. Based on this, the purpose and procedures of VIMSAS applied to IMO member states by trial, and IMSAS was enforced from January 1st 2016. IMSAS was implemented to ensure that IMO Member States, such as flag states, coastal states and port states that ratified the IMO Convention, are properly performing their given responsibilities and to ensure the effective implementation of the IMO instruments through the improvement of identified non-conformities. In this study, the auditing contents and procedures were verified based on IMO documents in order to prepare for the IMSAS audit of Republic of Korea scheduled for 2020. For this purpose, this study proposed an update of a directory, development of monitoring system for information reporting required by IMO instruments, designation of relevant experts, preparation of an English version of related national laws, training of IMSAS auditors and establishment of an IMSAS audit response team for audit of IMSAS in 2020 by referring to the results of the VIMSAS for Republic of Korea, major findings of the VIMSAS of other IMO member states, and Consolidated Audit Summary Report (CASR), which was submitted at the 5th IMO III sub-committee.