Automated pharmacovigilance system

• Main Authors: O. A. Loginovskaya, P. A. Grosheva, A. S. Zinkevich
• Format: Article
• Language: Russian
• Published: Izdatelstvo OKI 2018-05-01
• Series: Качественная клиническая практика
• Subjects: 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
• Online Access: https://www.clinvest.ru/jour/article/view/67

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.