• Title/Summary/Keyword: Regulatory Reporting

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Characteristics of Cardiovascular Adverse Drug Reactions Reported to KFDA (식품의약품안전청에 보고된 심혈관계 약물유해반응의 특성 분석)

  • Rhew, Ki-Yon;Cho, Hea-Kyoung;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.41-46
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    • 2012
  • Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.

ADR of Herbal Medicines (한약물의 ADR)

  • Ko Seong-Gyu;Jang Byoung Eun;Choi Jae Sun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.18 no.4
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    • pp.957-964
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    • 2004
  • Herbal medicines are increasingly used to treat various diseases and lots of studies have been reported that they had benefits in treating and preventing of diseases. But organic toxicity is increasingly recognized as herbal medicines become more popular in industrialized countries. Some herbal products potentially benefit people with lots of diseases, however these benefits remain generally unproved in humans, and a greater awareness for potential adverse effects is required. A herb containing a wide variety of, mostly unknown, substances may well include some with unwanted effects. This review focuses on emerging organic toxicities that have been observed associated with various herbal preparations involving the liver, kidney, and heart, and patterns of organ injury, potential risk factors for organic toxicities. In addition to the potential for organic toxicities, drug drug interactions between herbal medicines and conventional agents may affect the efficacy and safety of concurrent medical therapy. Appropriate reporting and regulatory system to monitor herbal toxicity are required, in conjunction with ongoing scientific evaluation of the potential benefits of phytotherapy.

A Movement Towards the Accrual Based IPSAS Implementation in Developing Countries: Evidence from Jordan

  • SHEHADEH, Esam
    • The Journal of Asian Finance, Economics and Business
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    • v.9 no.3
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    • pp.389-397
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    • 2022
  • As the Jordanian government is in the process of implementing accrual-based IPSAS, this study aims to provide academics' perspectives on the effective implementation of accrual-based IPSAS in Jordan to authorities and regulators. The findings of a survey of 124 accounting professors at Jordanian institutions reveal that adopting accrual-based IPSAS will aid in presenting the realistic financial status of governmental bodies, with various advantages to adopting accrual-based IPSAS (e.g., enhance assets and liabilities management, decision-making process, transparency, expenditures management). On the other side, we discovered that change is met with reluctance because the majority of public-sector accountants are untrained and unqualified to apply the accrual-based IPSAS. Another main challenge is the cost of implementing the accrual-based IPSAS in the Jordanian public sector is very high. To address these issues, employees should be motivated by providing suitable training programs, reward systems, and top management support and commitment to a successful transition. Finally, we suggested that Jordanian governments commit to using IPSAS in the public sector to increase residents' socioeconomic advantages. Public sectors should implement IPSASs for improved management, transparency in financial reporting, accountability, and regulatory and supervisory agencies.

Role of Forensic Accounting to Strengthen Corporate Governance : An Empirical Study

  • Bhasin, Madan Lal
    • The Journal of Economics, Marketing and Management
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    • v.5 no.1
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    • pp.1-20
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    • 2017
  • An increasing number of researchers are finding that 'poor' CG is a leading factor in dismal performance, manipulated financial reports, and unhappy stakeholders. Undoubtedly, qualified, trained and mature Chartered Forensic Accountants (CFA's) can prove to be a valuable asset to the corporate sector, and gradually help to improve their CG system. The fundamental objective of this study is to find out "how can we integrate the expertise of the FA to improve the overall CG scenario prevalent in India?" This is a preliminary investigation of the necessary skills, educational and training requirements for CFA's to improve CG system. During 2011-12, a questionnaire-based survey was conducted in the NCR of India using a sample size of 120 practicing chartered accountants, accounting academics, and potential users of FA services. Results indicate that potential practitioners, academics and users agree that "critical thinking, written & oral communication, legal knowledge, auditing skills, deductive analysis, investigative flexibility, analytical proficiency and unstructured problem-solving are the most important skills required for the CFAs." Moreover, we found that all of the skills investigated in this study are 'potentially' important for the CFAs, which the educators at the Universities should use as an overall guide while designing their FA curriculum."

Development of Pre-Service and In-Service Information Management System (iSIMS) (원전 가동전/중 검사정보관리 시스템 개발)

  • Yoo, H.J.;Choi, S.N.;Kim, H.N.;Kim, Y.H.;Yang, S.H.
    • Journal of the Korean Society for Nondestructive Testing
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    • v.24 no.4
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    • pp.390-395
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    • 2004
  • The iSTMS is a web-based integrated information system supporting Pre-Service and In-Service Inspection(PSI/ISI) processes for the nuclear power plants of KHNP(Korea Hydro & Nuclear Power Co. Ltd.). The system provides a full spectrum coverage of the inspection processes from the planning stage to the final report of examination in accordance with applicable codes, standards, and regulatory requirements. The major functions of the system includes the inspection planning, examination, reporting, project control and status reporting, resource management as well as objects search and navigation. The system also provides two dimensional or three dimensional visualization interface to identify the location and geometry of components and weld areas subject to examination in collaboration with database applications. The iSIMS is implemented with commercial software packages such as database management system, 2-D and 3-D visualization tool, etc., which provide open, updated and verified foundations. This paper describes the key functions and the technologies for the implementation of the iSIMS.

Management Changes of Hazardous Air Pollutants Sources and Its Proposed Improvement in Korea (유해대기오염물질 배출원 관리의 변천과 개선방향)

  • Kim, Jong-Ho;Lee, Jeong Joo
    • Journal of Korean Society for Atmospheric Environment
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    • v.29 no.5
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    • pp.536-544
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    • 2013
  • Even a small amount of hazardous air pollutants could have a harmful influence upon human beings, animals and plants. Hazardous air pollutants have the properties of toxicity, canceration and organism accumulation. They include heavy metals, volatile organic compounds, polycyclic aromatic hydrocarbons, dioxin, etc. The Clean Air Conservation Act has defined specific hazardous air pollutants and designated 35 pollutants, distinguishing them from common air pollutants for special control. This study investigates the history of the controls of specific hazardous air pollutants with reference to some relevant laws and regulations in Korea. It investigates the regulations at the permission stage, such as the restrictions on installation of emission facilities, the permission and reporting of installation of emission facilities, and the regulations at the operation stage, such as maintaining permissible emission levels, installation of measuring devices, dues for emission, self-measurement and securing environmental engineers. The current regulatory management is not so satisfactory in regards to the serious effects of specific hazardous air pollutants upon the human body. An advanced new concept, like the maximum available control technology in US, the facilities management standards, which will soon take effect, will be able to lessen the emissions of fugitive hazardous air pollutants. In addition, this study discusses some possible stricter controls on the emission facilities of specific hazardous air pollutants and proposes some measures to maintain and supplement the current systems.

A Study on the Application of Systematic Literature Review for Post-Market Clinical Evaluation of Medical Devices: Focused on the Ophthalmic Electrosurgical system (시판 후 의료기기 임상평가를 위한 체계적 문헌고찰 활용 방안 연구: 안과용전기수술기 사례를 중심으로)

  • Kim, Byung Gwan;Choi, Young Sook;Kim, Mi Sun;Yang, Seok-Jo
    • Journal of Biomedical Engineering Research
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    • v.41 no.1
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    • pp.35-41
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    • 2020
  • In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

The Rational Regulation of Illegal & Harmful Information in Cyberspace (모바일 라이브 스트리밍 서비스의 불법·유해방송 근절에 관한 연구)

  • Song, You-Jin;Kim, Seung-In
    • Journal of the Korea Convergence Society
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    • v.8 no.9
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    • pp.231-236
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    • 2017
  • This study analyzes the characteristics of mobile live streaming service, the illegal and harmful information characteristics of mobile live streaming service for the purpose of eradicating illegal and harmful broadcasting, and shows illegal and harmful broadcast on the mobile live streaming service and eradication plan. First, we reviewed the mobile live streaming service, illegal and harmful broadcasts through literature review, and secondly surveyed illegal and harmful broadcasts of mobile live streaming services and their awareness and countermeasures. As a result, it is confirmed that the mobile live streaming service is illegal, harmful broadcasting exposure frequency is high, illegal, and harmful broadcasting exposure is caused by characteristics of real time broadcasting rather than user's. In order to eradicate the illegal and mobile information about the mobile live streaming service, it is necessary to fix the illegal service and harmful broadcasting reporting system, but the government has confirmed the requirements for regulatory measures. From a microscopic point of view, it will be necessary to investigate the illegal use of mobile live streaming services and the eradication of harmful information.

A Study on the Policy Formation Process of Research Ethics System: Focusing on the United States (연구윤리제도의 형성과정에 관한 연구: 미국을 중심으로)

  • Lee, Song-Ho;Chung, Il-hwan
    • Korean Journal of Comparative Education
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    • v.28 no.6
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    • pp.1-28
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    • 2018
  • Korea is striving to establish a research ethics system, but there is still a disagreement as to the level of government involvement in research ethics. Therefore, this study analyzed the formation process of research ethics system in the United States and sought to derive implications for Korea's research ethics policy. The analysis of the present status of the research ethics policy and laws of the United States showed that i) the establishment of regulatory system is done only after the principles of the research ethics or the guideline are presented first in the academic fields; ii) the responsibility for research ethics is to be shared by the federal government and the research institute, and the primary responsibility for research is given to the research institute and the secondary responsibility to the government; iii) the government has imposed a minimum extent of strong regulation on unethical research; and iv) it is necessary to extend the responsibility of unethical research from the individual level to the structural level.

Discrepancies Between Implementation and Perceived Effectiveness of Leading Safety Indicators in the US Dairy Product Manufacturing Industry

  • Derlyke, Peter Van;Marin, Luz S.;Zreiqat, Majed
    • Safety and Health at Work
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    • v.13 no.3
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    • pp.343-349
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    • 2022
  • Background: In the United States, the dairy product manufacturing industry has consistently had higher rates of work-related nonfatal injuries and illnesses compared to the national average for industries in all sectors. The selection and implementation of appropriate safety performance indicators are important aspect of reducing risk within safety management systems. This study examined the leading safety indicators implemented in the dairy product-manufacturing sector (NAICS 3115) and their perceived effectiveness in reducing work-related injuries. Methods: Perceptions were collected from individuals with safety responsibilities in the dairy product manufacturing facilities. OSHA Incident Rate (OIR) and Days away, restricted and transferred (DART) rates from 2013 to 2018 were analyzed. Results: The perceived most effective leading were safety observations, stop work authority, near miss reporting, safety audits, preventative maintenance, safety inspections, safety training attendance, and job hazard analysis/safety analysis, respectively. The 6-year trend analysis showed that those implementing all eight top indicators had a slightly lower rates than those that did not implement all eight. Production focused mentality, poor training, and lack of management commitment were perceived as the leading causes of injuries in this industry. Conclusion: Collecting leading indicators with the unique interest to meet the regulatory requirements and to document the management system without the actual goal of using them as input to improve the system most probably will not lead to an effective reduction of negative safety outcomes. For leading indicators to be effective, they should be properly selected, executed, periodically evaluated and actions are taken when necessary.