• 한국임상약학회지
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• 제26권1호
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• pp.77-83
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• 2016

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

• 한국원자력학회:학술대회논문집
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• 한국원자력학회 1997년도 춘계학술발표회논문집(1)
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• pp.233-238
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• 1997

본 논문에서는 Safety-critical 소프트웨어를 위한 V'||'&'||'V 지침서(guideline) 개발 방법론을 제시한다. 즉, 기존의 산업계 표준인 IEEE Std-1012, IEEE Std-1059에서 논의되고 있는 개념을 근간으로 "독립성(independence)", "소프트웨어 안전성 분석(software safety analysis)", "COTS 평가(evaluation) 기준", "다른 보증(assurance) 조직들간의 관련성(relationship)" 등의 필수 안전 항목들을 추가하여 원전 안전성 시스템(NPP safety system)을 위한 V'||'&'||'V 지침서 개발 방법론을 제시하였다 제시된 방법론에는 V'||'&'||'V 지침서의 범위(scope), 승인기준(acceptance criteria) 부분인 지침서 프레임(guideline framework), V'||'&'||'V activities 및 methods 부분인 타스크(task) entrance 및 exit 기준(criteria), 리뷰 및 감사(review and audit), 테스팅 그리고 V'||'&'||'V material의 QA 레코드(records) 및 형상관리, 소프트웨어 검증 및 확인 계획서(Software Verification and Validation Plan : SVVP) 생성 등의 내용을 기술하고, Safety-critical 소프트웨어 V'||'&'||'V 방법론도 함께 제시하였다.

• 국제학술발표논문집
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• The 8th International Conference on Construction Engineering and Project Management
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• pp.243-248
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• 2020

In addition to a range of H&S documentation, a range of actions, beliefs, interventions, practices, and states are important in terms of achieving optimum construction H&S. Conclusions include that H&S documentation facilitates and assists planning, organising, leading, controlling, and coordinating H&S. Furthermore, current H&S documentation: is inappropriate in that it can be complex, generic, lengthy, onerous, repetitive (duplicative), and vague; engenders dubious practices; generally, 'does not add the potential value'; shifts the focus from the physical process, and could be improved. Recommendations include: industry associations should review their 'audit system' to interrogate the allocation of points; H&S documents must reflect the intention of the requirement; the synergy between H&S documentation, and actions, interventions, and practices should be investigated, digested, and focused upon, and 'audits', or rather inspections, should focus more on the physical process, actions, interventions, and practices, than documentation.

• 대한기관윤리심의기구협의회지
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• 제2권2호
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• 대한예방한의학회지
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• 제28권1호
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• pp.31-42
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• 2024

Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

• 해양환경안전학회지
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• 제23권7호
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• pp.783-790
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• 2017

해상교통안전진단제도의 해상교통시스템 적정성 평가 항목 중 통항안전성 근접도 평가 기준은 충돌확률이 $1.0{\times}10^{-4}$ 미만일 경우에 선박의 안전 확보가 가능하다고 제시하고 있다. 1970년대 선박 충돌에 관해 Fujii 와 Macduff의 연구를 시작으로 많은 연구자와 연구기관에서 충돌확률 예측 모델을 제시하였다. 이 같은 다양한 연구에서 충돌확률은 $1.0{\times}10^{-4}$을 크게 벗어나지 않는 수준이지만, 대부분 가정된 상황을 기준으로 제시됨에 따라 다양한 형태의 실제 항로 기준에 적용하는데 근거가 부족한 문제가 있다. 이 연구는 직선항로와 곡선항로를 통항한 선박들의 GICOMS 데이터를 이용하여 선박의 크기별로 근접도 평가를 조사하였다. 이를 근거로 모든 선박에 일률적으로 적용되던 평가 기준을 선박의 크기별로 근접도 평가를 적용 하는 것이 보다 더 합리적이라 판단되어 항로 형태에 따른 선박 크기별 충돌확률을 제시하였다. 향후 보다 다양한 상황과 형태의 항로에서의 해상교통시스템 적정성 평가 기법에 대한 정확성 개선연구가 필요하다.

• 한국식품위생안전성학회지
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• 제14권1호
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• pp.104-114
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• 1999

This study was conducted to find out the proper ways of implementation of Hazard Analysis Critical Control Point (HACCP) concepts applicable to the current Korean food inspection system. The following recommendations are based on an in-depth review of the Canadian Food Safety Enhancement Program (FSEP), which is one of the leading HACCP programs adapted to the food industry. Since 1997, the HACCP system has been voluntarily applied to meat processing plants in Korea in accordance with the Food Protection Law. But the guidelines are obscure and inadequate to expand to the diversity of food plants, and are therefore only applied to a limited number of plants of small scale enterprise. For these reasons, it is necessary to prepare an enhanced food safety control program focused not only on the HACCP plants but also on the non-HACCP plants. The national program should be the fundamental framework of a food safety control policy enforced by all the relevant authorities. The Prerequiste Program of Canadian Food Inspection Agency and Sanitation Standard Operating Procedures (SSOP) of FSIS are good example programs for the non-HACCP plants. These programs, which are a major part of the HACCP system, could easily be adapted to the Korean food industry. To improve the current HACCP implementation guideline, it is necessary to develop a detailed implementation manual, generic HACCP model, training program, and an audit program.

• 한국재난정보학회 논문집
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• 제8권3호
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• pp.310-318
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• 2012

본 연구의 목적은 국내 안전보건경영시스템의 올바른 정착과 지속적인 개선을 통한 산업재해를 줄이기 위한 시스템 성숙도평가를 제안하는데 있다. KOSHA 18001시스템 실행의 현재 수준파악과 성숙도 측정의 검증을 통한 결과로서 다음 내용으로 요약된다. 시스템의 지속적인 성숙도 등급 향상을 위해서는 경영층 인식부문(의사결정) 46.0%, 본사지원활동 32.0%, 현장실행참여 22.0%로 중요도 로 검증되었다. 본사/현장의 활동은 위험성평가, 안전보건 재해예방활동, 성과평가 및 모니터링, 자원관리 및 지원, 경영검토 및 개선 등 활동의 중요도 순으로 실행 우선순위가 결정되었다. 또한, 전문가 그룹은 시스템의 강점, 약점, 개선주제를 제시함으로써 지속적인 개선활동과 연계시켜야 시스템을 정착할 수 있다고 제시하였다. 셋째, 안전보건경영시스템 실행의 성숙도 등급을 관리할 수 있는 도구를 제시하였다.

• 통상정보연구
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• 제11권3호
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• pp.239-262
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• 2009

This study shed light on the status of Korean Kimchi industry in overseas markets and presented methods for promoting Kimchi industry of Gwangju Jeonnam metropolitan city and stimulating the export of Kimchi produced in Gwangju Jeonnam, a city that has come to the fore as the center of Kimchi industry, which aimed to explore the ways of ratcheting up competitiveness of Kimchi industry in the global market as Kimchi has become more likely to be globalized amid the recent "Korea Trend" boom and the growing consumption of fermented food. Therefore, methods for promoting Kimchi industry and stimulating the export of Kimchi should be explored to ensure the promotion of Kimchi industry and the stimulation of the export of Kimchi, ultimately restoring the status of Korea as the home of Kimchi, in consideration of the great spillover effect on the regional economy, through a series of measures such as the clusterization of Kimchi industry, expansion of cultural experience projects related to Kimchi for the globalization and the increased consumption of Kimchi, government support to increase Kimchi companies in size and achieve the modernization of Kimchi companies, introduction of Kimchi KS audit system and quality certification system, development of new product targeting global market and making Kimchi a high-end product, expansion of export, support of export market diversification, assurance of safety and price competitiveness of Kimchi, differentiated production and marketing strategy by means of technological research, and others.

• 경영과정보연구
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• 제6권
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• pp.137-162
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• 2001

Our business conglomerates are sharing their fates economically because of mutual debt warranty among their own affiliates and excessive financial loans. For this reason, it is inevitably restrictive to obtain the whole information on such conglomerates by individual and consolidated financial statements. To solve this problem, the system of combined financial statement was introduced through modifications of the Act of the outside audit of corporations in 1988. As a result, 15 out of this nation's 30 major business conglomerates prepared and submitted their own combined financial statements. In this paper, all financial statements are grouped into financial and non-financial parts, based on characteristics of business control and combined financial statement. Then the business size, financial rate and internal transactions for each of the conglomerates are analyzed, based on which problems of the combined financial statement as announced publicly are clarified. For the system, this study suggests improvement points such as a sufficient publication of any possible situations and interest coordination caused between the date of business settlement and that of preparing combined financial statements by applying principles of sharing to the evaluation of valuable instrument papers for investment and by determining the amount, 5% accounting for the total amount of debt warranty, foreign exchange assets and debts.