The risk management system as the important part of good pharmacovigilance practices (GVP)
Abstract
The risk management system includes the process of determining the probability of occurrence of undesirable effects of pharmacotherapy, identifying the extent and magnitude of the risk analysis and the choice of risk management strategy, the selection of necessary for this risk management techniques and strategies of ways to reduce it. Thus, the risk management system is a modern and efficient pharmacovigilance tools aimed to improve the effectiveness and safety of pharmacotherapy.
About the Authors
A. S. Kazakov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
K. E. Zatolochina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
B. K. Romanov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
T. M. Bukatina
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
N. Yu. Velts
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
References
1. Guideline on good pharmacovigilance practices (GVP) — Module V (Rev 1) EMA/838713/2014 [Electronic resource]. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf.
2. Guideline on good pharmacovigilance practicies (Good Pharmacovigilance Practice — GVP) Cited 06.11.2014 [Electronic resource]. URL: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/oo/Pages/farmakanadzor.aspx (in Russian).
3. On the changes of the Federal law «On the drug circulation » ¹ 429-FZ at 22.12.2014. Available at juristic database «Consultant Plus» (cited 17.12.2015).
4. Federal law «On the drug circulation» ¹ 61-FZ at 12.04.2010. Available at juristic database «Consultant Plus» (cited 17.12.2015).
Review
For citations:
Kazakov A.S., Zatolochina K.E., Romanov B.K., Bukatina T.M., Velts N.Yu. The risk management system as the important part of good pharmacovigilance practices (GVP). Safety and Risk of Pharmacotherapy. 2016;(1):21-27. (In Russ.)
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