Preparation of a periodic safety update report
This article is a continuation of the publication «Standard form of a Periodic safety update report» in the previous issue of the journal. This article recommendations for the preparation of Periodic safety update report (PSUR) to ensure the development of this report document license holders of cer...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Russian |
| Published: |
Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
2018-03-01
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| Series: | Безопасность и риск фармакотерапии |
| Subjects: | |
| Online Access: | https://www.risksafety.ru/jour/article/view/93 |
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| _version_ | 1839581788480995328 |
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| author | B. K. Romanov R. N. Alyautdin S. V. Glagolev V. A. Polivanov A. E. Krasheninnikov |
| author_facet | B. K. Romanov R. N. Alyautdin S. V. Glagolev V. A. Polivanov A. E. Krasheninnikov |
| author_sort | B. K. Romanov |
| collection | DOAJ |
| description | This article is a continuation of the publication «Standard form of a Periodic safety update report» in the previous issue of the journal. This article recommendations for the preparation of Periodic safety update report (PSUR) to ensure the development of this report document license holders of certificates of registration of drugs for subsequent submission to the section «Periodic report» Federal Database «Automated system of Pharmacovigilance» and subsequent evaluation of the Roszdravnadzor the information of scientific and clinical nature are presented. This practical advices with step by step recommendations for medical authors are presented. |
| format | Article |
| id | doaj-art-dce02aa5e4a24b85a0929a80cdc8eceb |
| institution | Matheson Library |
| issn | 2312-7821 2619-1164 |
| language | Russian |
| publishDate | 2018-03-01 |
| publisher | Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» |
| record_format | Article |
| series | Безопасность и риск фармакотерапии |
| spelling | doaj-art-dce02aa5e4a24b85a0929a80cdc8eceb2025-08-04T10:16:31ZrusMinistry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»Безопасность и риск фармакотерапии2312-78212619-11642018-03-016161010.30895/2312-7821-2018-6-1-6-1093Preparation of a periodic safety update reportB. K. Romanov0R. N. Alyautdin1S. V. Glagolev2V. A. Polivanov3A. E. Krasheninnikov4Russian National Research Medical University named after N.I. Pirogov; Scientific Centre for Expert Evaluation of Medicinal Products.Scientific Centre for Expert Evaluation of Medicinal Products.Federal Service for Surveillance in Healthcare (Roszdravnadzor).Information and Methodological Centre for Expert Evaluation, Recording and Analysis of Circulation of Medicinal Products.Independent Noncommercial Organization «National Research Center of Pharmacovigilance».This article is a continuation of the publication «Standard form of a Periodic safety update report» in the previous issue of the journal. This article recommendations for the preparation of Periodic safety update report (PSUR) to ensure the development of this report document license holders of certificates of registration of drugs for subsequent submission to the section «Periodic report» Federal Database «Automated system of Pharmacovigilance» and subsequent evaluation of the Roszdravnadzor the information of scientific and clinical nature are presented. This practical advices with step by step recommendations for medical authors are presented.https://www.risksafety.ru/jour/article/view/93eriodic safety update reportrussia, license holdersdrugspsur |
| spellingShingle | B. K. Romanov R. N. Alyautdin S. V. Glagolev V. A. Polivanov A. E. Krasheninnikov Preparation of a periodic safety update report Безопасность и риск фармакотерапии eriodic safety update report russia, license holders drugs psur |
| title | Preparation of a periodic safety update report |
| title_full | Preparation of a periodic safety update report |
| title_fullStr | Preparation of a periodic safety update report |
| title_full_unstemmed | Preparation of a periodic safety update report |
| title_short | Preparation of a periodic safety update report |
| title_sort | preparation of a periodic safety update report |
| topic | eriodic safety update report russia, license holders drugs psur |
| url | https://www.risksafety.ru/jour/article/view/93 |
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