Preparation of a periodic safety update report

Abstract

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.

Keywords

• eriodic safety update report
• russia, license holders
• drugs
• psur