Preparation of a periodic safety update report
https://doi.org/10.30895/2312-7821-2018-6-1-6-10
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.
About the Authors
B. K. Romanov
Russian National Research Medical University named after N.I. Pirogov; Scientific Centre for Expert Evaluation of Medicinal Products.
Russian Federation
Russian Federation
Romanov Boris K. Professor, Department of Pharmacology, Faculty of Pediatrics. MD, DSc (Med).; Deputy General Director for Science Research. MD, DSc (Med).
R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products.
Russian Federation
Russian Federation
Alyautdin Renad N. Director for Centre for Expert Evaluation of Drug Safety. MD, DSc (Med), prof.
S. V. Glagolev
Federal Service for Surveillance in Healthcare (Roszdravnadzor).
Russian Federation
Russian Federation
Glagolev Sergey V. Deputy Head of Department — Chief of Department of Pharmacovigilance, PhD.
V. A. Polivanov
Information and Methodological Centre for Expert Evaluation, Recording and Analysis of Circulation of Medicinal Products.
Russian Federation
Russian Federation
Polivanov Vitaly A. Director of the Centre for Monitoring Effective, Safe and Rational use of Medicinal Products.
A. E. Krasheninnikov
Independent Noncommercial Organization «National Research Center of Pharmacovigilance».
Russian Federation
Russian Federation
Krasheninnikov Аnatoly Е. General Director, PhD.
References
1. Romanov BK, Alyautdin RN, Darmostukova MA, Glagolev SV, Polivanov VA. Standard form of the Periodic Safety Update Report. Safety and Risk of Pharmacotherapy 2017; 5(4): 148-160. (In Russ.)
2. Order of Roszdravnadzor of 15.02.2017 № 1071 «On approval of the Procedure of pharmacovigilance». [Internet] (cited 2017 December 1). Available from: http:// http://www.roszdravnadzor.ru/documents/39003. (In Russ.).
3. The decision of the Board Eurasian economic Commission of 3.11.2016 № 87 «About approval of Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union». [Internet] (cited 2017 December 1). Available from: http://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87. (In Russ.).
4. Snegireva II, Zatolochina KE, Ozeretskovsky ON, Romanov BK, Mironov AN. Vaccine pharmacovigilance in Russia, legal and regulatory framework, current stage of development. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2014; 4: 27-31. (In Russ.).
5. Benefit-risk methodology project. Work package 3 report: Field tests [Internet] (cited 2017 December 1). Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/09/WC500112088.pdf.
6. Uniform requirements for manuscripts submitted to biomedical journals: preparation and editing of biomedical publications [Internet] (cited 2017 December 1). Available from: http://www.scardio.ru/content/images/documents/Trebovania2010. pdf (In Russ.).
7. Medical Dictionary for Regulatory Activities (MedDRA) [Internet] (cited 2017 December 1). Available from: https://www.meddra.org (In Russ.).
Review
For citations:
Romanov B.K., Alyautdin R.N., Glagolev S.V., Polivanov V.A., Krasheninnikov A.E. Preparation of a periodic safety update report. Safety and Risk of Pharmacotherapy. 2018;6(1):6-10. (In Russ.) https://doi.org/10.30895/2312-7821-2018-6-1-6-10
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