Methods of working with pharmacovigilance signals
Abstract
This article is about the efficiency of web based systems for pharmacovigilance (PV) processes management in connection with pharmacovigilance signals based on case study of the implementation of Flex Databases PV system. It describes principles of signals management, provides analyses of modern methods of signal management (quality and quantity), and also describes perspective methods of signals management. The article highlights the importance of signal management in pharmacovigilance as an obligatory process for all companies-holders of registration certificate and investigation companies in all EAEU member states, including Russia.
About the Authors
O. A. Loginovskaya
Flex Databases, Russian Federation; Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
B. K. Romanov
Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
A. S. Kolbin
First Pavlov State Medical University of Saint Petersburg, Saint Petersburg, Russia; Saint Petersburg State University, Saint Petersburg, Russia
Russian Federation
Russian Federation
H. . Yastrebova
Uppsala Monitoring Centre, WHO
Russian Federation
Russian Federation
K. V. Domoroshchenkov
Flex Databases
Russian Federation
Russian Federation
V. P. Kolbatov
Flex Databases
Russian Federation
Russian Federation
R. V. Sukhov
Flex Databases
Russian Federation
Russian Federation
K. A. Koshechkin
Scientific Center for Expertise of Medical Application Products, Ministry of Health of the Russian Federation
Russian Federation
Russian Federation
References
1. Antoni F.Z., et al. Good Signal Detection Practices: Evidence from IMI PROTECT. Drug Saf. 2016; 39: 469-490.
2. Романов Б.К., Лепахин В.К., Журавлева Е.О. и др. Совершенствование принципов управления сигналами по безопасности лекарственных препаратов для медицинского применения. Безопасность и риск фармакотерапии. 2016; 1: 10-20.
3. Романов Б.К., Глаголев С.В., Поливанов В.А. и др. Мониторинг безопасности лекарственных средств. Безопасность и риск фармакотерапии. 2014; 3 (4): 11-14.
4. Казаков А.С., Затолочина К.Э., Романов Б.К., и др. Система управления рисками - важная часть правил надлежащей практики фармаконадзора, Безопасность и риск фармакотерапии. 2016; 1: 21-27.
5. Правила надлежащей практики фармаконадзора Евразийского экономического союза (утв. Решением ЕАЭК №87 от 03.11.2016, вступили в силу с 06.05.2017, дата обращения - 27.10.2017). [URL]: http://docs.eaeunion.org/docs/ru-ru/01411948/cncd_21112016_87.
6. http://www.meddra.org/how-to-use/tools/commercial-tools.
7. http://www.flexdatabases.com/en/other-solutions/pharmacovigilance.
Review
For citations:
Loginovskaya O.A., Romanov B.K., Kolbin A.S., Yastrebova H., Domoroshchenkov K.V., Kolbatov V.P., Sukhov R.V., Koshechkin K.A. Methods of working with pharmacovigilance signals. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2017;(3):38-42. (In Russ.)
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