Automated pharmacovigilance system
Abstract
This article is about efficiency of online systems for pharmacovigilance (PV) processes management based on case study of implementation of PV system by Flex Databases. Automation of PV processes is a topic of interest for R&D companies in EurAsEC countries as the EEC (Eurasian Economic Commission) adopted guidelines for Good Pharmacovigilance Practice (GVP). This article describes principles of operation of the system, provides analyses of implementation process and demonstrates results of case study of implementing PV system in several leading Russian pharmaceutical companies.
Keywords
фармаконадзор,
надлежащая практика фармаконадзора,
онлайн система по управлению процессами фармаконадзора,
клинические исследования,
программное обеспечение для проведения клинических исследований,
Flex Databases,
pharmacovigilance,
PV,
GVP,
Good Pharmacovigilance Practice,
pharmacovigilance system,
PV system,
clinical trials,
software for clinical trials,
Flex Databases
About the Authors
O. A. Loginovskaya
Flex Databases, Russian Federation; Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
P. A. Grosheva
Flex Databases, Russian Federation
Russian Federation
Russian Federation
A. S. Zinkevich
Flex Databases, Russian Federation
Russian Federation
Russian Federation
References
1. Решение №87 Об утверждении Правил надлежащей практики фармаконадзора Евразийского экономического союза от 03 ноября 2016 г.
2. ICH Harmonised Tripartite Guideline, Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B(R2), Current Step 4 version dated 5 February 2001.
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH M2 EWG, Electronic Transmission of Individual Case Safety Reports Message Specification (ICH ICSR DTD Version 2.1), Final Version 2.3 Document Revision February 1, 2001.
4. http://www.meddra.org/how-to-use/tools/commercial-tools.
5. http://www.flexdatabases.com/en/other-solutions/pharmacovigilance.
Review
For citations:
Loginovskaya O.A., Grosheva P.A., Zinkevich A.S. Automated pharmacovigilance system. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2016;(4):43-47. (In Russ.)
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