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OBJECTIVE To provide policy referen ce for local marketing authorization holder （MAH）to implement their main responsibility of drug life cycle supervision and the Guiding Principles of Pharmacovigilance Inspection to be officially released. METHODS Taking 15 MAH in Shanghai who recently underwent pharmacovigilance inspection as the research objects ，the social network analysis was used to explore the logical relationship between MAHs ’enterprise attributes and inspection problems ， summarize the problems found ，analyze the causes ，and put forward corresponding countermeasures. RESULTS & CONCLUSIONS The problems found in this pharmacovigilance inspection were mainly in aspects of organization ，personnel management ，quality management system ，report quality and so on. The reasons for these problems included light punishment ，which lead to the enterprise management ’s lack of attention to the pharmacovigilance system ，unclear problem handling and risk control mechanism ， imperfect quality management system documents ，inadequate personnel training ，etc. MAH needs to pay more attention to pharmacovigilance，allocate corresponding human and resources ，constantly improve the pharmacovigilance quality management system，and improve the enforceability and effectiveness of the pharmacovigilance system. At the same time ，it is suggested that government departments should strengthen policy guidance ， publicity and implementation ， and combine with third-party institutional platforms such as industry associations to promote the smooth implementation of Good Validation Practice .
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OBJECTIVE To provide the suggestions and reference for the follow-up update of Guiding Principles of Clinical Application of Novel Anti -tumor Drugs （hereinafter referred to as “Guiding Principles ”）. METHODS The update of 2018-2021 editions of Guiding Principles were compared ；the changes of its style ，the variety and quantity of novel anti-tumor drugs ，the classification of indications ，the target ，the inclusion of medical insurance and other aspects were analyzed. Its change trend and possible problems were summarized. RESULTS There was a great change in the style of Guiding Principles in 2020 edition，i.e. deleting the item of “clinical application management ”and adding the item of “attached table ”. Totally 33 novel anti-tumor drugs were included in the 2018 edition of Guiding Principles ，and the number of novel anti-tumor varieties increased to 46，60 and 77 in 2019，2020 and 2021 editions，respectively. The time when the new varieties were included in Guiding Principles was the same year or one year after the domestic market time. Totally 26 varieties of national medical insurance negotiation were included in the 2018 edition of Guiding Principles ，and 8，10 and 12 varieties were added respectively in 2019，2020 and 2021 editions on the basis of the previous edition . Novel anti-tumor drug in the 2018 edition of Guiding Principles mainly focused on traditional targets such as EGFR，HRE2 and VEGFR. However ，since 2019，the number of new targets such as PD-1，PARP，ALK and CDK had been increasing，among which domestic original drugs accounted for a large proportion. CONCLUSIONS The revision of Guiding Principles aims to further guide the clinical application of novel anti-tumor drugs from the professional level of health technology. The new varieties and indications conform to the principles of scientificity and dynamics ；domestic original varieties have developed rapidly ，and innovative varieties to novel target have emerged. The follow-up update of Guiding Principles should refer to authoritative medical guidelines and high-quality evidence- based evidence. Attention should be paid to the types of tumors lacking therapeutic drugs and the clinical value of oushun- novel anti-tumor drugs.
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Pediatric medical devices cannot meet the existing medical needs now. In consideration of the difficulty that clinical trials conducted in pediatric population, reasonable extrapolation of adult device data to pediatric population can maximize the use of existing data, as well as reduce unnecessary clinical trials in pediatric populations. It can also help accelerate the development and marketing of pediatric medical devices and ensure the clinical demand of pediatric devices. We analyzed the related guiding principles in America, and explored the extrapolation of medical device data to pediatric population in China from the perspective of medical device technology evaluation, hoping to provide reference in promoting China's data extrapolation.
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Child , Humans , China , Data Collection , Equipment and Supplies , TechnologyABSTRACT
As special commodities , drugs had closely relationships with human beings′health and life safety .Impurity, which would influence the stability and efficacy of drugs , was closely related to the quality , safety and efficacy of drugs .With more and more attendance had been attached to the impurity′s control in the development of drugs , researchers turned their attentions to the analysis of trace impurity .In this paper , related progresses in recent 10 years were summarized , including guiding principles in impurity re-search, technologies in qualitative research and general approaches in quantitative research .
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La participación de la enfermera(o) dentro del proceso de donación de órganos debe ser entendida como parte fundamental en cuanto al área de competencia, debido a que su cuerpo de conocimiento incluye no solo la preservación de los órganos sino todo un conjunto de actividades que denotan el desarrollo de su quehacer: el cuidado al ser humano de forma integral.
Nurses participation in the process of organ donation must be understood as a fundamental part in their area of competence, considering their body of knowledge that includes not only the preservation of the organs but a series of activities that denotes the development of their task: holistic care of the human being.
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Transplantation , NursesABSTRACT
Objective To explore the influencing factors of the implementation of general hospital guiding principles of nursing classification (trial) in clinical nursing work.Methods 152 nurses and 143 doctors were selected from three 3A-level hospitals in Changchun and were investigated with self-designed questionnaires,and the data were statistically analyzed.Results The first three influencing factors were the responsibility,quantity and basic qualities of nurses.Grading nursing standards,leadership value degree and the differences of disease had lower influencing degree.There were cognitive differences between nurses and doctors on the influencing factors on implementation of the principle.Conclusions To improve execution of the principles,the cognition of doctors and nurses on the principles must be unified.Increasing nurses' basic quality and responsibility and carrying out effective human resources management are very useful.
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OBJECTIVE:To investigate the use of antibacterials in our hospital before and after the issuing of Guiding Principles for Clinical Application of Antibacterials.METHODS:A total of 2 880 cases histories(60/month) of patients who had been discharged from hospital were randomly sampled from Oct.2002 to Sep.2006 for a review of the use of antibacterials in our hospital.RESULTS:The application rate of antibacterials before and after the issuing of the Guiding Principles for Clinical Application of Antibacterials were 94.3% and 83.8%,respectively;and the rates of combined drug use were 39.5% and 27.9%,respectively,of which,the rates of bigeminy were 30.8% and 25.3%,respectively and the rates of trigeminy were 8.7% and 2.5%,respectively.CONCLUSION:The application rate of antibacterials in our hospital was lowered significantly after the issuing of the guiding principle and the rate of antibacterials used in single kind increased while the rate of combined drug use decreased.
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OBJECTIVE:To investigate the implementing status of the Guiding Principles of Clinical Application of Antibacterials.METHODS:A total of 60 case histories of patients who had undergone thyroidectomy and discharged from hospital were selected in July 2005 from six third level hospitals(10 from each hospital) in Changsha and Guangzhou for a questionnaire survey and a statistical analysis based on Guiding Principles of Clinical Application of Antibacterials.RESULTS:The average hospital stay was(10.18?3.71) days;the average cost of hospitalization was(7 538.50?631.99) yuan and the average cost on antibacteirals was(705.21?91.10) yuan.The average compliance rates in the choice of drug kinds and medication opportunity were 35% and 80% respectively.The average medication duration was 6.38 days.CONCLUSION:The implementation of the Guiding Principles of Clinical Application of Antibacterials was far from ideal,thus the related department should offer training and tighten control on the use of antibacterials.