The development of information channels for improving the processes of monitoring and analyzing information on the safety of medicinal products is an important critical process of pharmacovigilance and the duty of the authorized person for pharmacovigilance (FDA) at the manufacturer of medicinal products. As part of the effective implementation of this routine process in the [...]
It is impossible to fully assess the safety profile of a new drug based only on clinical studies conducted for the purpose of subsequent registration of the drug. FN allows health authorities to continuously assess the balance of benefits and risks throughout the entire life cycle of a drug and makes it possible to identify [...]
Krasheninnikov A.E., Matveev A.V. Autonomous non-profit organization "National Scientific Center of Pharmacovigilance", 127051, Russia, Moscow, st. Malaya Sukharevskaya, pl. d. 2, p. 2. It is known that the use of drugs in modern clinical practice is accompanied by the risk of side effects, the cause of which, in many cases, is the level of drug [...]
The Council of the Eurasian Economic Commission adopted a decision of November 3, 2016 No. 87 on the approval of the rules of good practice for pharmacovigilance of the Eurasian Economic Union. Within the framework of these rules, a risk management plan should be formed. The risk management plan (hereinafter - RMP) contains information that [...]
According to the Organization for Economic Cooperation and Development (OECD), Russia is the most educated country in the world, overtaking Canada, Japan, Israel and the United States. More than half of Russians have higher education. More than 270,000 people from 168 countries of the world come to study at Russian universities annually. Education in Russia [...]
N.B. Lazareva1, E.V. Shikh1, E.V. Rebrova1, A.Yu. Ryazanova2 1 First Moscow State Medical University. THEM. Sechenov (Sechenovsky University), Moscow, Russian Federation 2 Volgograd State Medical University, Volgograd, Russian Federation The rapid progress in the creation and use of a huge number of drugs (MP), on the one hand, makes it possible to increase the effectiveness [...]
DOI: 10.15690 / vsp.v18i3.2032 A.V. Matveev1, 2, A.E. Krasheninnikov1, E.A. Egorova2, E.I. Konyaeva2, K.N. Koryanova3 1 National Research Center for Pharmacovigilance, Moscow, Russian Federation 2 Medical Academy. S.I. Georgievsky as a part of the Crimean Federal University them. IN AND. Vernadsky, Simferopol, Republic of Crimea, Russian Federation 3 Pyatigorsk Medical and Pharmaceutical Institute - a [...]
A.V. Matveev1,2, A.E. Krasheninnikov1, E.A. Egorova2 1 - National Research Center for Pharmacovigilance, Moscow, Russian Federation; 2 - Crimean Federal University V.I. Vernadsky, Medical Academy. S. I. Georgievsky, Simferopol, Russian Federation Drug use is inherently associated with adverse drug reactions (ADRs). According to WHO-ART, the Adverse reaction terminology (ART) developed by the World Health Organization [...]
A.E. Krasheninnikov, Cand. farm. Sci., General Director of ANO "National Scientific pharmacovigilance center ", Moscow, anatoly.krasheninnikov@drugsafety.ru A. V. Matveev, Ph.D. honey. Sciences, Associate Professor of the Department of Internal Medicine No. 1 with a course of clinical Pharmacology Medical Academy. S. I. Georgievsky Federal State Autonomous Educational Institution of Higher Education "Crimean Federal University named [...]
R.S. Safiullin, A.E. Krasheninnikov In various national systems of the global global pharmacovigilance architecture, pharmaceutical workers have traditionally been one of the leading links in the collection and upstream channel of information on adverse events associated with drug use. The organization of pharmacovigilance determines the procedure for collecting spontaneous reactions about adverse drug events, as [...]
