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: | Book |
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Ministry of Health of the Russian Federation, Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»,
2018-03-01T00:00:00Z.
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| Online Access: | Connect to this object online. |
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| Summary: | 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. |
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| Item Description: | 2312-7821 2619-1164 10.30895/2312-7821-2018-6-1-6-10 |