alexa Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System | OMICS International | Abstract
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Review Article

Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System

Gildeeva GN* and Belostotsky AV

Pharmaceutical Science Department, I.M. Sechenov First Moscow State Medical University, Russia

*Corresponding Author:
Gildeeva GN
Pharmaceutical Science Department
Chair of Organization and Management in the Field of Drugs Circulation
I.M. Sechenov First Moscow State Medical University, Russia
Tel: +7495656 2717
E-mail: [email protected]

Received Date: April 14, 2017; Accepted Date: April 25, 2017; Published Date: May 04, 2017

Citation: Gildeeva GN, Belostotsky AV (2017) Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System. Pharm Regul Aff 6:187. doi: 10.4172/2167-7689.1000187

Copyright: © 2017 Gildeeva GN, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

The review outlines the current issues of Pharmacovigilance System in the Russian Federation, namely present state of regulatory aspects of PV system in Russia, regulatory requirements in Russia and in Eurasian Economic Union, review of the causes of under-reporting of ADRs. Specific focus has been made on topical issues such as a harmonization of the requirements to the Pharmacovigilance System, currently underway in Russia, the issue of Guidelines on Good Pharmacovigilance Practice (GVP) in the Eurasian Economic Union. These actions are aimed at improving and harmonizing the rules governing the main aspects of the Pharmacovigilance System in the Russian Federation. Also the review analyses one of the most important aspects in development of a new Pharmacovigilance System-the attitude towards pharmacovigilance in patients and healthcare professionals.

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