Pharmacovigilance (pharmacovigilance) – Kind of activity, aimed at identifying, evaluation, понимание и предотвращение нежелательных последствий применения лекарственных препаратов.

Within the framework of the EAEU, pharmacovigilance is regulated by the Decision of the Council of the Eurasian Economic Commission dated 3 november 2016 y.. №87 “On Approval of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union” Good Pharmacovigilance practices GVP (download)

CRO Pharmasistens provides pharmacovigilance services:

• Организация сбора, processing and analysis of ADRs
• Организация локальной системы фармаконадзора
• Организация call-центра 24 /7
• Подготовка и написание Периодических отчетов о безопасности (PSUR)
• Подготовка и написание Планов управления рисками (RMP)

Organization of a local pharmacovigilance system on the territory of the EAEU is mandatory for applicants, planning to register
medicinal products in the territory of the Union. Master file of the pharmacovigilance system of the marketing authorization holder or brief
characteristics of the pharmacovigilance system of the marketing authorization holder are provided in the Module 1 registration dossier (Decision
Council of the Eurasian Economic Commission from 03.11.2016 № 78 “On the Rules for Registration and Expertise of Medicinal Products for Medical
applications”).