Methods of working with pharmacovigilance signals

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 met...

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Main Authors: O. A. Loginovskaya, B. K. Romanov, A. S. Kolbin, H. . Yastrebova, K. V. Domoroshchenkov, V. P. Kolbatov, R. V. Sukhov, K. A. Koshechkin
Format: Article
Language:Russian
Published: Izdatelstvo OKI 2018-05-01
Series:Качественная клиническая практика
Subjects:
Online Access:https://www.clinvest.ru/jour/article/view/93
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author O. A. Loginovskaya
B. K. Romanov
A. S. Kolbin
H. . Yastrebova
K. V. Domoroshchenkov
V. P. Kolbatov
R. V. Sukhov
K. A. Koshechkin
author_facet O. A. Loginovskaya
B. K. Romanov
A. S. Kolbin
H. . Yastrebova
K. V. Domoroshchenkov
V. P. Kolbatov
R. V. Sukhov
K. A. Koshechkin
author_sort O. A. Loginovskaya
collection DOAJ
description 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.
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spelling doaj.art-b3a8d23b408740fca9fb18a28ee01cda2024-03-14T18:09:04ZrusIzdatelstvo OKIКачественная клиническая практика2588-05192618-84732018-05-0103384293Methods of working with pharmacovigilance signalsO. A. Loginovskaya0B. K. Romanov1A. S. Kolbin2H. . Yastrebova3K. V. Domoroshchenkov4V. P. Kolbatov5R. V. Sukhov6K. A. Koshechkin7Flex Databases; Первый Санкт-Петербургский государственный медицинский университет им. акад. И.П. ПавловаФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава РоссииПервый Санкт-Петербургский государственный медицинcкий университет имени акад. И.П.Павлова; Санкт-Петербургский государственный университетУппсальский центр мониторинга ВОЗFlex DatabasesFlex DatabasesFlex DatabasesФГБУ «Научный центр экспертизы средств медицинского применения» Минздрава РоссииThis 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.https://www.clinvest.ru/jour/article/view/93фармаконадзорсигналы в фармаконадзореклинические исследованияпрограммное обеспечение для проведения клинических исследованийflex databasespharmacovigilancepvpharmacovigilance signalsclinical trialssoftware for clinical trialsflex databases
spellingShingle O. A. Loginovskaya
B. K. Romanov
A. S. Kolbin
H. . Yastrebova
K. V. Domoroshchenkov
V. P. Kolbatov
R. V. Sukhov
K. A. Koshechkin
Methods of working with pharmacovigilance signals
Качественная клиническая практика
фармаконадзор
сигналы в фармаконадзоре
клинические исследования
программное обеспечение для проведения клинических исследований
flex databases
pharmacovigilance
pv
pharmacovigilance signals
clinical trials
software for clinical trials
flex databases
title Methods of working with pharmacovigilance signals
title_full Methods of working with pharmacovigilance signals
title_fullStr Methods of working with pharmacovigilance signals
title_full_unstemmed Methods of working with pharmacovigilance signals
title_short Methods of working with pharmacovigilance signals
title_sort methods of working with pharmacovigilance signals
topic фармаконадзор
сигналы в фармаконадзоре
клинические исследования
программное обеспечение для проведения клинических исследований
flex databases
pharmacovigilance
pv
pharmacovigilance signals
clinical trials
software for clinical trials
flex databases
url https://www.clinvest.ru/jour/article/view/93
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AT hyastrebova methodsofworkingwithpharmacovigilancesignals
AT kvdomoroshchenkov methodsofworkingwithpharmacovigilancesignals
AT vpkolbatov methodsofworkingwithpharmacovigilancesignals
AT rvsukhov methodsofworkingwithpharmacovigilancesignals
AT kakoshechkin methodsofworkingwithpharmacovigilancesignals