Methods of working with pharmacovigilance signals

• 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: фармаконадзор; сигналы в фармаконадзоре; клинические исследования; программное обеспечение для проведения клинических исследований; flex databases; pharmacovigilance; pv; pharmacovigilance signals; clinical trials; software for clinical trials
• Online Access: https://www.clinvest.ru/jour/article/view/93
• ISSN: 2588-0519; 2618-8473

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.