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The frequent several ethical events in recent years suggested carry out the construction of ethical governance system involving human health-related research under the background of national governance. The subjects of ethical governance include the government, medical institutions, universities, scientific research institutes, enterprise, ethics committees, researchers, the public, etc., the multiple subjects are interrelated and interact with each other to restrict and standardize ethics through different governance tools. However, there are some problems in China’s ethical governance, such as the relative lag in the construction of ethical governance concept and system, insufficient multi-party participation, the difficulty in sole legislation to solve risk and ethical problems, the specification cannot be met, inadequate supervision, insufficient accountability for violations, researchers lack ethical awareness, ethical education lags behind and insufficient information disclosure to the public. It should be taken such as countermeasures as paying attention to the theoretical research of ethical governance system, strengthening the construction of ethical governance system, pluralistic co governance, agile governance, strengthening legislation, improving norms, implementing supervision, strengthening the construction of ethics committee, talent training, training researchers, ethical education, popular science public, academic self-discipline, information disclosure and public participation, so as to build a scientific and technological ethics governance system in line with China’s national conditions and in line with international standards, and contribute China’s wisdom for world ethical governance.
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By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.
Subject(s)
European Union , Industry , Reagent Kits, DiagnosticABSTRACT
On the basis of introducing FDA's regulatory measure and relevant requirement for life-cycle management of combination product, this paper aims to discuss corresponding countermeasure for supervision system construction in consideration of domestic drug-device combination product's current situation, in order to promote innovative development of relevant industries.
Subject(s)
Device Approval , Drug Approval , United States , United States Food and Drug AdministrationABSTRACT
As more and more non-core services are outsourced to other companies, it is necessary for hospitals to build an effective outsourcing project supervision system to improve service quality and reduce potential risks. The authors introduced the construction practice of outsourcing project supervision system in the Second Affiliated Hospital of Zhejiang University School of Medicine of emphasizing four core elements: system guarantee, organization establishment, standard unification and quality monitoring. The authors also summarized five important aspects of building a thorough, consolidated, less risky and user-friendly outsourcing project supervision system: selecting suppliers carefully under unified standards; orienting dynamic supervision with details, problems and outcome; strengthening quality improvement and dual supervision equally; upgrading the concept of supervision and build a good cooperative relationship with suppliers; paying attention to the whole process management with learned lessons.
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One of the important part for ensuring maternal and child safety is to strength maternal and child health service supervision.A comprehensive supervision system for that guarantees its implementation.However, at this stage, the work faces the problems of insufficient effectiveness of laws and regulations, insufficient professional capacity of health supervisors, and insufficient supervision of emerging issues in maternal and child health service.With the implementation of "double random" spot check model in post-event supervision, primary health supervisors are facing some difficulties with the professional tasks.Combined with the situation, Shanghai municipal health supervision department established a key control point monitoring model for maternal and child health services, improving the training efficiency of primary health supervisors, offering guidance for health supervisors, which provides useful exploration in building and reforming the maternal and child health service supervision system.
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OBJECTIVE:To provide reference for the improvement of supervision system of online drug sale in China. METH-ODS:Usingonline pharmacyonline drugstoreinternet drugssupervisionas keywords,CNKI,Wanfang database from Jan. 2015 to Jan. 2016 and related websites were retrieved,experience about legislation,legal provisions and regulatory bodies in the United States,Britain,Germany and other countries were summarized. The problems existing in the current supervision system in China were analyzed,and related suggestions were proposed. RESULTS & CONCLUSIONS:The legal system of the online drug sale in the United States,Britain,Germany and other countries is more complete,legislation content is relatively perfect,pay-ing attention to the combination of administrative supervision and industry supervision. The supervision system of online drug sale in China exists problems as follows as legislation level relatively lower,conflict between laws and regulations;the legislation con-tent being not perfect,contents missing or provisions blur in many aspects;law enforcement existing in the government depart-ments,industry regulation being weak and others. It is suggested that the country should develop high-order law when improving the supervision system of online drug sale,modifying the existing law or promulgating the relevant specialized laws by legal form rather than regulations and rules;develop clear,actionable law and learn from foreign related systems (such as electronic evi-dence,blacklist)to improve legal contents;and further clear the powers and responsibilities of the regulatory authorities,actively develop industry associations(such as pharmaceutical association,etc.)to conduct supervision for online drug sale.
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The sound implementation of a legal system depends on scientific ideas and an efficient supervision system. Presently, the drug supervision system is a period of transition, with the prospects of establishing a modern supervision system that incorporates the ideals of risk management. To this end, the responsibilities of the drug super-vision agency shall be adjusted horizontally and vertically so as to enhance the efficiency of supervision and to avoid an overlap of functions or supervision vacancy. We should enhance the capacity for governance and cultivate the self-discipline of the industry and associations. The implementation of administrative accountability is necessary to ensure that institutional responsibilities are fulfilled and thereby realize public health.
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Eestablishing a scientific supervision system is essential to achieve a better environment for teaching and learning and improve teaching quality in medical college.We took undergraduate education evaluation as an important supervising subject and made a scientific evaluation program for teaching,learning,and testing,based on specific features of medical college.The practice of the program proves to be successful.We present the main contents in this article.
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Clinical teaching supervision system exhibited several problems in the imple-mentation process such as the team of supervision being not reasonable enough and the connotation of supervision not extensive and not going far in depth enough and so on. Through the way of strengthening the team of the clinical teaching construction,expanding the connotation and improving the functions of supervision,we can construct a new effective supervision system for clinical school teaching.
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It is high time to regulate the Chinese medical ethics review system and construct a supervision system of medical ethics review.According to the guideline of WHO,models of supervision system of medical ethic review in certain developed countries,and national conditions,this paper proposes several countermeasures including perfecting related legal system,constructing certification system of ethics review committee,and formulating integrated contents and procedure of supervision.