The algorithm for the proper preparation of the PSA can be presented in the form of 17 recommendations as follows. It is necessary to track in advance the timing of the preparation of the PSAR and plan the work schedule in such a way that the compilers have enough time to collect the material, process [...]
The preparation of a PSAR, also referred to as a Periodic Safety Report, is an important part of the life cycle of any medicinal product. The periodic safety report is designed to minimize the risks of drug use and continually improve the benefit /safety ratio. PSAR are prepared either by special departments of pharmaceutical companies, [...]
Pharmacovigilance is the most important system that controls the entire life span of any medicinal product. Bodies providing a full range of services for pharmacovigilance should be fully staffed with appropriate means and equipment. As stated in the Rules of Good Pharmacovigilance Practice, achieving the required the level of quality in the implementation of a [...]
"Pharmacovigilance system" is a system organized by the holders of registration certificates for medicinal products and authorized bodies of the member states of the Eurasian Economic Union to fulfill the tasks and responsibilities of pharmacovigilance, designed to control the safety of medicinal products, timely detection of all changes in the assessment of the ratio - [...]
The main barriers to the organization and proper functioning of the pharmacovigilance system at the enterprise are the lack of methodological guidelines, recommendations, experience and practical skills, the imperfection of the regulatory framework, and the lack of trained personnel in this area. The result of the study showed that 5% of respondents could turn to [...]
The pharmacovigilance system audit – is the regular, ordered, independent and documented process of collecting the information and impartial assessment of the facts, which represents the functioning of the pharmacovigilance system [1]. The main goal of conducting the pharmacovigilance system audit is the confirmation of compliance, implementation and functioning efficacy of the pharmacovigilance system through [...]
The inspection is the external test. The inspection on compliance with pharmacovigilance requirements by the market authorization holders is carried out by the regulatory bodies of the EAEU state-members. The pharmacovigilance inspections should be held by the inspectors, appointed by the national regulatory bodies, authorized to hold the examination of the indoor space, to get [...]
Aim. To ground the necessity of taking into account the double-component nature of the phenomenon of poor activity of the population in the system of pharmacovigilance so as to work out the measures, aimed at development of UR reporting. The process of formation of a modern system of pharmacovigilance in Russia with appropriate level of reporting on the cases [...]
Abstract Among the diseases of the cardiovascular system, arterial hypertension due to the significant prevalence of the disease, a high risk of complications and low patient compliance takes a special place. One of the most important factors playing a role in the pathogenesis of hypertension is the activation of the renin-angiotensin-aldosterone system. Angiotensin-converting enzyme inhibitors [...]
This article is devoted to the study of the organization of pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan. To achieve this goal, an expert assessment of the experience of post-marketing pharmacovigilance activities and a survey in relation to messages on the safety and effectiveness of drugs were carried out, post-marketing pharmacovigilance activities at [...]
