🗊Презентация Pharmacovigilance. Services, science, education. The main legal acts in PV

The Main Legal Acts in PV Good Pharmacovigilance Practice (GVP) of the Eurasian Economic Union, approved by the Decision of the Council of the Eurasian Economic Commission No. 87 of 03/11/2016 (entered into force on 06.05.2017) Federal Law No. 61-FZ of April 12, 2010, About the Circulation of Medicinal Products (Chapter 13) Law of the Ministry of Health of Russia No. 682n of 09/07/2016 “On approval of the form of the document containing the results of monitoring the effectiveness and safety of medicinal products for medical use, carried out by the holder or owner of the registration certificate of the medicinal products or an authorized legal entity” Order of Roszdravnadzor No. 1071 of February 15, 2017 “On Approval of the Procedure for the Implementation of Pharmacovigilance” Order of the Ministry of Health of Russia dated 07.09.2015 No. 5539 “On approval of the procedure for the implementation of selective quality control of drugs for medical use”

Structure of National Pharmacovigilance Research Center

PHARMACOVIGILANCE SERVICES

Grant from the Federal State Budgetary Institution National Medical Center for Pharmacovigilance Research

QPPV Survey Data in the Russian Federation

Examples of unloading from automated security data processing

Functions of Expert Advisory Body Examination of Serious Adverse Reactions Issuance of independent peer review findings Coordination and development of recommendations for pharmacotherapy Proposals on pharmacovigilance to regulatory authorities Management of research in the field of pharmacovigilance

Our possible points of interactions

Our possible points of interactions