This study reviewed the regulatory safety management system for prevention of side effects of veterinary medical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure the safety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing, test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the good manufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establish regulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinary medicine of FDA in the United States has been operated side effects reporting system of veterinary medical devices from user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices for animals, it should be required to improve regulation related to the licensing procedures, GMP system, and the side effects reporting system in our country.
Chun, Woo-Sung;Park, Dea-Woo;Lee, Sang-Ick;Kim, Eung-Sik;Kim, Hong
Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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2009.10a
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pp.457-460
/
2009
u-IT Convergence appliances study and are developed in communication by development of u-IT technology, broadcasting, portal, contents, equipment and all fields of business such as solution. This treatise presents valuation basis of, economic performance, administration sex etc. by temperature, pressure, own, storehouse, gas, justice for humidity sensors and valuation basis that define u-IT Convergence, and sense information u-IT Convergence devices and terminal. Also, studied standardization standard of u-IT Convergence network appliance that follow in valuation basis for u-IT Convergence devices. Is going to contribute establish value as estimation product that equip stability and authoritativeness through correct certification assessment for technological development and appliances on Ubiquitous information-oriented society through this research and accomplish standardization.
Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.
Adom, Dickson;Daitey, Samuel T.;Yarney, Lily;Fening, Peggy A.
Safety and Health at Work
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v.11
no.4
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pp.450-457
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2020
Background: The production of glass beads in Ghana is greatly impacted by the ingenuity of Ghanaian women. Preliminary investigations revealed the lack of interest on the part of women due to poor working conditions as a result of the influence of culture-specific silence. Therefore, the study investigated the poor working conditions faced by these industrious women with the ultimate goal of suggesting ways they can be empowered. Methods: A phenomenological study was conducted in two indigenous glass bead communities in Ghana. Data were solicited via direct observations, personal interviews and focus group discussions. Twenty-six purposively sampled respondents were recruited for the study. Data from the study were analyzed using Interpretative Phenomenological Analysis. Results: The results confirmed that the elderly women glass bead makers are much influenced by the Ghanaian culture of silence. This prevents the women from speaking about the challenges they are facing in their work. Also, the women are silenced because of the fear of losing their jobs as well as the reluctance of their male managers to remedy the challenges they encounter in the course of work. This has resulted in poor remuneration, lack of insurance packages for workers, certification, and absence of personal protective tools for the women. Conclusion: The study tasks the government of Ghana, the Legal Advocacy for Women in Africa (LAWA), the Fair Wages and Salaries Commission in Ghana, the Ghana Trade Union as well as the Local Government Workers' Union to empower the women to sustain the glass bead industry in Ghana.
Jae-Hyeon Kim;Dong-Min Lee;Myeong-Jin Lee;Yeong-Hoon Choi;Ji-Hun Kwon;Jong-Whoa Na
Journal of Advanced Navigation Technology
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v.28
no.1
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pp.68-76
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2024
With the recent rapid growth of the domestic and international unmanned aerial vehicle (UAV) market and the increasing importance of UAV operations in urban centers, such as UAMs, the safety management and regulatory framework for human life and property damage caused by UAV failures has been emphasized. In this study, we conducted a comparative analysis of risk-cost models that evaluate the risk of an operating area for safe UAM flight path planning, and identified the main limitations of each model to derive considerations for future model development. By providing a basic model for improving the safety of UAM operations, this study is expected to make an important contribution to technical improvements and policy decisions in the field of UAM flight path planning.
This study was performed to improve of Health Functional Food(HFF) through investigating the label system. The logo on HFF to increase the reliance, understanding and quality warranty for consumers was developed through competition. In order to investigate the consumer's awareness about HFF label system a nationwide survey was conducted in metropolitan areas (6 cities) and middle-sizes cities (6 cities). The subjects was 2000(male 519, female 1481) adults aged 20 over, and information was collected by in-person interviews. The major results were as follows. 63.0% of consumer responded they need certification mark for HFF and trust function information of text/graphic format than text format. 85.3% of consumers chose the long claim including the mechanism because 38% reported that they could confide the information, 36% reported it is easy to understand and 26% reported that they thought it is more effective than short claim. As 58.8% of the total consumers answered that the manufacturers marked the nutrition function claim without the permit of the KFDA, a reliable certification mark developed by this research is expected to contribute in improving the label system of HFF, rising reliability and perception of consumer.
Numerical prediction methods were applied to investigate the turbulent air currents and air-conditioning efficiency in an underground subway station, and the results compared to experimental data. The Shin-gumho Station($8^{th}$ floor underground and 43.6m in depth) in Seoul was selected for the analysis. The entire station was covered for simulation and the ventilation mode was ordinary. The ventilation diffusers were modeled as 95 square shapes of $0.6m{\times}0.6m$ in the lobby and as 222 square shapes in the platform. Cooling air of $47,316m^3/h$ was supplied and the returned air of $33,980m^3/h$ is exhausted in the lobby and the cooling air of $33,968m^3/h$ is supplied and the returned air of $76,190m^3/h$ was exhausted in the platform which is the same as the experimental data. The cases of the screen-door-closed and open were respectively investigated. A total of 7.5million grids were generated and the whole domain divided into 22 blocks for MPI efficiency of calculation. Large eddy simulation (LES) was applied to solve the momentum and energy equation.
Journal of the Korea Academia-Industrial cooperation Society
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v.18
no.10
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pp.281-289
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2017
This study was conducted to evaluate understanding of patient safety culture and the factors that influence this understanding among general hospital employees. To collect data, this study surveyed 343 employees of five general hospitals that were located in G metropolitan city and were authorized through medical institute certification. The data were collected from March 12 to April 21, 2017. For the data collected, a t-test, variance analysis, post-hoc analysis, and multiple regression analysis were conducted. The analyses revealed that the scores of understanding of patient safety culture were $3.27{\pm}.27$ with a perfect score of 5. Analysis of differences in understanding of patient safety culture revealed significant differences according to hospital service career, present department service career, professional career, and work units. Factors that influence understanding of patient safety culture were more than 11 year- hospital service career, 6 and 10 service years, and ward employees. Overall, the results of this study suggest that employees should receive education to improve understanding of patient safety culture and measures to change the understanding should be developed.
Some contracting States of the Convention on International Civil Aviation (commonly known as the Chicago Convention) issue FAOC(Foreign AOC and/or Operations Specifications) and conduct various safety audits for the foreign operators. These FAOC and safety audits on the foreign operators are being expanded to other parts of the world. While this trend is the strengthening measure of aviation safety resulting in the reduction of aircraft accident, it is the source of concern from the legal as well as economic perspectives. FAOC of the USA doubly burdens the other contracting States to the Chicago Convention because it is the requirement other than that prescribed by the Chicago Convention of which provisions are faithfully observed by almost all the contracting States. The Chicago Convention in its Article 33 stipulates that each contracting State recognize the validity of the certificates of airworthiness and licenses issued by other contracting States as long as they meet the minimum standards of the ICAO. Consequently, it is submitted that the unilateral action of the USA, China, Mongolia, Australia, and the Philippines issuing the FOAC to the aircraft of other States is against the Convention. It is worry some that this breach of international law is likely to be followed by the European Union which is believed to be in preparation for its own unilateral application. The ICAO established by the Chicago Convention to be in charge of safe and orderly development of the international civil aviation has been in hard work to both upgrade and emphasize the safe operation of aircraft. As the result of these endeavors, it prepared a new Annex 19 to the Chicago Convention with the title of "Safety Management" and with the applicable date 14 November 2013. It is this Annex and other ICAO documents relevant to the safety that the contracting States to the Chicago Convention have to observe. Otherwise, it is the economical burden due to probable delay in issuing the FOAC and bureaucracies combined with many different paperworks and regulations depending on where the aircraft is flown. It is exactly to avoid this type of confusion and waste that the Chicago Convention aimed at when it was adopted in 1944. The State of the operator shall establish a system for both the certification and the continued surveillance of the operator in accordance with ICAO SARPs to ensure that the required standards of operations are maintained. Certainly the operator shall meet and maintain the requirements established by the States in which it operate. The authority of a State stops where the authority of another State intervenes or where the former has yielded its power by an international agreement for the sake of international cooperation. Hence, it is not within the realm of the State to issue FAOC towards foreign operators for the reason that these foreign operators are flying in and out of the State. Furthermore, there are other safety audits such as ICAO USOAP, IATA IOSA, FAA IASA, and EU SAFA that assure the safe operation of the aircraft, but within the limit of their power and in compliance with the ICAO SARPs. If the safety level of any operator is not satisfactory, the operator could be banned to operate in the contracting States with watchful eyes until the ICAO SARPs are met. This time-honoured practice has been applied without any serious problems. Besides, we have the new Annex 19 to strengthen and upgrade with easy reference for contracting States. We don't have no reason to introduce additional burden to the States by unilateral actions of some States. These actions have to be corrected. On the other hand, when it comes to the carriage of the Personal or Pilot Log Book, the Korean regulation requiring it is in contrast with other relevant provisions of USA, USOAP, IOSA, and SAFA. The Chicago Convention requires in its Articles 29 and 34 only the carriage of the Journey Log Book and some other certificates, but do not mention the Personal Log Book at all. Paragraph 5.1.1.1 of Annex 1 to the Chicago Convention even makes it clear that the carriage in the aircraft of the Personal Log Book is not required on international flights. The unique Korean regulation in this regards giving the unnecessary burden to the national flag air carriers has to be lifted at once.
Factor analysis is estimated using housewives's intention data in Seoul province. Rice consumers considered safety, high nutritive value, shape and cultivation region as important factors in buying rice. The factors of food safety are brand and quality certification mark. The differences of two housewife groups on safety factor are caused by residence type, employment existence and residence region. The marketing strategies for rice containing food safety target housewives living in apartment, Gang Nam region. Also selling extension for target consumers housewives should be employed.
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