Our company provides a services related to CR. In particular: Conducting clinical trials of early phases (Phase I) and bioequivalence studies, conducting post-marketing safety studies; Conducting pharmacovigilance in CR. Therefore, we decided to explain in a popular way what is meant by CR and into which phases it is divided. Clinical research of medicinal products [...]
Analysis of reports of adverse reactions (AD) and cases of lack of effectiveness in the use of drugs (MP), which form the basis of pharmacovigilance, expert assessment and prediction of potential risks of drug use in clinical practice are among the tasks of the effective functioning of the pharmacovigilance system (FP). To ensure the possibility [...]
Following the rules of good practice for pharmacovigilance of the Eurasian Economic Union, one of the processes for documenting the critical process of working with HP at the manufacturer of medicinal products, which should be reflected in the Master File of the FN System (MFSF) - the main document of the pharmacovigilance system, is the [...]
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 [...]
