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The analysis and the review of patient registers with implanted medical devices as the tool of the post-marketing clinical monitoring of medical devices 植入医疗器械患者登记表的分析与审查，作为医疗器械上市后临床监测的工具
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/article_5d135f4a278c60.31396650
Айсылу Валеева, A. Valeeva, А В Дмитриева, Anna Dmitrieva, Денис Шарикадзе, D. Sharikadze, Татьяна Николаевна Иванова, Tatyana S. Ivanova, Елена Борисова, Elena Borisova
{"title":"The analysis and the review of patient registers with implanted medical devices as the tool of the post-marketing clinical monitoring of medical devices","authors":"Айсылу Валеева, A. Valeeva, А В Дмитриева, Anna Dmitrieva, Денис Шарикадзе, D. Sharikadze, Татьяна Николаевна Иванова, Tatyana S. Ivanova, Елена Борисова, Elena Borisova","doi":"10.35576/article_5d135f4a278c60.31396650","DOIUrl":"https://doi.org/10.35576/article_5d135f4a278c60.31396650","url":null,"abstract":"The article conducts the analysis of the practice in the application of patient registers with implanted medical devices by regulatory authorities of various countries for vigilance of medical devices, as well as review of current patient registers their categories and applicability. In addition, the article review the recommendations of The International Medical Device Regulators Forum (IMDRF) on development, implementation and application methodology of patient registers.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"74 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132794041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developments in Rules of state registration of medical devices 医疗器械国家注册规则的发展
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A159E30.48455158
Анфиса Миронова, A. Mironova
{"title":"Developments in Rules of state registration of medical devices","authors":"Анфиса Миронова, A. Mironova","doi":"10.35576/ARTICLE_5D135F4A159E30.48455158","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A159E30.48455158","url":null,"abstract":"This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134329104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Features of toxicology tests of medical devices within the national legislation of the Russian Federation 俄罗斯联邦国家立法范围内医疗器械毒理学试验的特点
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A38BA93.84633878
Иван Каргин, I. Kargin, Маргарита Владимировна Новикова, M. Novikova, Ольга Тарасенко, O. Tarasenko
{"title":"Features of toxicology tests of medical devices within the national legislation of the Russian Federation","authors":"Иван Каргин, I. Kargin, Маргарита Владимировна Новикова, M. Novikova, Ольга Тарасенко, O. Tarasenko","doi":"10.35576/ARTICLE_5D135F4A38BA93.84633878","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A38BA93.84633878","url":null,"abstract":"The procedure and the rules of toxicology testing of medical devices (MD) for the purpose of their registration in the framework of the national legislation of the Russian Federation are discussed.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"126 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115459755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
2019: time for innovations (following the conference «FarmMed Appeal–2019») 2019年:创新时间(继«2019年农业呼吁»会议之后)
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A303E79.40852064
Михаил Мурашко, M. Murashko
{"title":"2019: time for innovations (following the conference «FarmMed Appeal–2019»)","authors":"Михаил Мурашко, M. Murashko","doi":"10.35576/ARTICLE_5D135F4A303E79.40852064","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A303E79.40852064","url":null,"abstract":"The article presents major directions of the modern regulation over circulation of medicines and medical devices including biomedical cellular products. \u0000Particular attention is focused on matters of the purchase of medicines and medical devices, the drug label and the maintenance of a safety of medical \u0000products.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121754705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Global trends in circulation of medical devices 医疗器械流通的全球趋势
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A0D2A04.23758829
Елена Владимировна Астапенко, E. Astapenko, Анна Кортошкина, Anna KORTOShKINA
{"title":"Global trends in circulation of medical devices","authors":"Елена Владимировна Астапенко, E. Astapenko, Анна Кортошкина, Anna KORTOShKINA","doi":"10.35576/ARTICLE_5D135F4A0D2A04.23758829","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A0D2A04.23758829","url":null,"abstract":"The article presents main tendencies in development of the legal and regulatory environment in circulation of medical devices in world’s major states. The article depicts major developed in regulatory aspects in countries members of the International Medical Device Regulators Forum (IMDRF) that took place in the late 2018 – early 2019, which are important for subjects of circulation of medical devices which planning their activities not only in the Russian Federation territory, but also abroad.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128449400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Glembotskaya G.T., Eremin S.Yu. Scientific and practical approach to optimizing costs on development and promotion of drugs Glembotskaya g.t.， Eremin S.Yu。科学实用的方法优化药物开发和推广成本
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A416E79.00661162
Галина Тихоновна Глембоцкая, Galina Glembockaya, Станислав Юрьевич Еремин, S. Eremin
{"title":"Glembotskaya G.T., Eremin S.Yu. Scientific and practical approach to optimizing costs on development and promotion of drugs","authors":"Галина Тихоновна Глембоцкая, Galina Glembockaya, Станислав Юрьевич Еремин, S. Eremin","doi":"10.35576/ARTICLE_5D135F4A416E79.00661162","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A416E79.00661162","url":null,"abstract":"In order to identify promising strategic development possibilities for the pharmaceutical industry in the Russian Federation, a pilot study was conducted, which has analyzed the main trends in the development of innovative medicines. As a result of the content analysis of available sources of scientific literature, the characteristics of options used in the world practice for increasing the innovative activity of individual subjects and the pharmaceutical market as a whole are presented. Possible reserves for the further development of the innovative component of the pharmaceutical market within the framework of the concept of personalized medicine according to the P4 principle (predictive - personalized - preventive - participatory) are identified and structured. \u0000The results of use by individual pharmaceutical companies of scientifically and practically justified approaches to optimizing the costs of development and promoting drugs are presented. The advantages and real prospects of a generally accepted method to reduce the cost of development by «expanding the pharmacological effect» (label expansion) of already existing drugs with a known safety profile in the world practice are shown. A scientific generalization and structuring of the goals and results of the post-registration phase of clinical trials to expand the pharmacological action of a number of drugs already existed at the market have been carried out.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"94 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126583210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Films as a trend in the creation of innovation medicine delivery systems (review) 电影作为创新药物输送系统的发展趋势(综述)
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A4F3788.19551999
Н.П. Демина, N. Demina, Анна Титова, A. Titova, Е. О. Бахрушина, E. Bahrushina, Марина Вакина, Marina G Vakina, Екатерина Булова, Ekaterina Bulova
{"title":"Films as a trend in the creation of innovation medicine delivery systems (review)","authors":"Н.П. Демина, N. Demina, Анна Титова, A. Titova, Е. О. Бахрушина, E. Bahrushina, Марина Вакина, Marina G Vakina, Екатерина Булова, Ekaterina Bulova","doi":"10.35576/ARTICLE_5D135F4A4F3788.19551999","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A4F3788.19551999","url":null,"abstract":"The review have been investigated the question of development of innovative medications in the film as dosage form. The article have been studied the history of created the films, using in medicine, the created medicines, film classification, film technology, excipients and development perspective.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"64 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126851331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Discrepancies in drug labeling texts as a cause of medication errors 药品标签文本的差异是导致用药错误的原因
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A5A9F62.45142755
Анна Сергеевна Кузьмина, A. Kuz'mina, Ирина Асецкая, Irina Aseckaya, Виталий Поливанов, V. Polivanov, С К Зырянов, S. Zyryanov, Сергей Глаголев, S. Glagolev
{"title":"Discrepancies in drug labeling texts as a cause of medication errors","authors":"Анна Сергеевна Кузьмина, A. Kuz'mina, Ирина Асецкая, Irina Aseckaya, Виталий Поливанов, V. Polivanov, С К Зырянов, S. Zyryanov, Сергей Глаголев, S. Glagolev","doi":"10.35576/ARTICLE_5D135F4A5A9F62.45142755","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A5A9F62.45142755","url":null,"abstract":"Contradictions in drug labeling texts for various medicinal products with the same active substance can cause medication errors. We found discrepancies in the Russian drug labeling texts for cefotaxime and oral forms of amoxicillin/clavulanic acid, 500 + 125 mg. We analyzed Russian database of spontaneous reports. In 18.5% spontaneous reports with cefotaxime as a suspected drug and in 22.0% spontaneous reports with amoxicillin/clavulanate in forms for oral administration as a suspected drug we detected medication errors resulted from deviations from those items of approved drug labels which were not harmonized for different drug manufacturers. Such problems require the participation of regulatory authorities in order to eliminate existing discrepancies.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"502 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123065076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ethical, clinical and scientific aspects of a research of medicinal drugs that alter progress of a multiple sclerosis at the current staging point 在当前阶段改变多发性硬化症进展的药物研究的伦理、临床和科学方面
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A66DC90.50757456
Елена Ивашкова, Ivashkova Ev, Марина Вотинцева, Marina Votinceva, Андрей Николаевич Петров, A. Petrov, Игорь Столяров, I. P. Stolyarov
{"title":"Ethical, clinical and scientific aspects of a research of medicinal drugs that alter progress of a multiple sclerosis at the current staging point","authors":"Елена Ивашкова, Ivashkova Ev, Марина Вотинцева, Marina Votinceva, Андрей Николаевич Петров, A. Petrov, Игорь Столяров, I. P. Stolyarov","doi":"10.35576/ARTICLE_5D135F4A66DC90.50757456","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A66DC90.50757456","url":null,"abstract":"The article introduces ethical, clinical and scientific aspects of a medicinal drugs research, as well as particularities of conducting of clinical researches \u0000on a multiple sclerosis. The article presents major regulatory document on conduction of clinical researches of medicines in the Russian Federation.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132854094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Directions for improving the organization of emergency medical services, specialized medical care and medical evacuation in federal subject of Russia 关于改进俄罗斯联邦主体紧急医疗服务、专门医疗护理和医疗后送组织的指示
Vestnik Roszdravnadzora Pub Date : 2019-06-26 DOI: 10.35576/ARTICLE_5D135F4A728E49.79827942
Сергей Федорович Багненко, S. Bagnenko, Ильдар Миннулин, I. Minnulin, Александр Григорьевич Мирошниченко, A. Miroshnichenko, Вадим Теплов, V. Teplov, Николай Разумный, N. Razumnyy
{"title":"Directions for improving the organization of emergency medical services, specialized medical care and medical evacuation in federal subject of Russia","authors":"Сергей Федорович Багненко, S. Bagnenko, Ильдар Миннулин, I. Minnulin, Александр Григорьевич Мирошниченко, A. Miroshnichenko, Вадим Теплов, V. Teplov, Николай Разумный, N. Razumnyy","doi":"10.35576/ARTICLE_5D135F4A728E49.79827942","DOIUrl":"https://doi.org/10.35576/ARTICLE_5D135F4A728E49.79827942","url":null,"abstract":"The article presents main directions for improving the organization of emergency medical services (EMS), specialized medical care and medical evacuation in federal subject of Russia. These directions of development include: the formation of three-tier health system in federal subject of Russia, the integration of ambulance stations and territorial disaster medicine centres, the creation of EMS regional dispatch centres, the development of emergency departments, the modernization of medical information systems for EMS.","PeriodicalId":307832,"journal":{"name":"Vestnik Roszdravnadzora","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2019-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132919382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
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