NICOTINE DEPENDENCE AND NEUROPSYCHIC EFFECTS OF VARENIKLIN

2021-05-29T02:18:56+03:00

Throughout the world, smoking remains one of the leading preventable causes of illness and premature death. Cigarette smoking is a risk factor for various diseases such as cancer (including lung cancer), chronic obstructive pulmonary disease (COPD), hypertension, coronary heart disease, and cerebrovascular disorders. Various treatments that help people successfully quit smoking have important effects on [...]

NICOTINE DEPENDENCE AND NEUROPSYCHIC EFFECTS OF VARENIKLIN2021-05-29T02:18:56+03:00

NON-STEROID ANTI-INFLAMMATORY DRUGS: SAFETY PROBLEMS APPLICATIONS

2021-05-29T02:15:42+03:00

According to the World Health Organization, non-steroidal anti-inflammatory drugs (NSAIDs) are the second most used after antibiotics. More than 30 million people in the world take NSAIDs every day, with 40% of patients over the age of 60. Considering that large quantities of these drugs are taken without a prescription and due control by a [...]

NON-STEROID ANTI-INFLAMMATORY DRUGS: SAFETY PROBLEMS APPLICATIONS2021-05-29T02:15:42+03:00

Algorithm for the proper preparation of a periodic safety report

2021-05-29T02:12:41+03:00

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 [...]

Algorithm for the proper preparation of a periodic safety report2021-05-29T02:12:41+03:00

Preparation of periodic safety reports

2021-05-29T02:09:30+03:00

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, [...]

Preparation of periodic safety reports2021-05-29T02:09:30+03:00

What tools and equipment are needed for a full range of services for pharmacovigilance?

2021-05-29T02:05:17+03:00

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 [...]

What tools and equipment are needed for a full range of services for pharmacovigilance?2021-05-29T02:05:17+03:00

Pharmacovigilance system

2021-05-25T00:10:08+03:00

"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 - [...]

Pharmacovigilance system2021-05-25T00:10:08+03:00

Outsourcing of pharmacovigilance

2021-05-25T00:07:12+03:00

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 [...]

Outsourcing of pharmacovigilance2021-05-25T00:07:12+03:00

The preparation for the pharmacovigilance system audit

2021-05-25T00:04:09+03:00

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 preparation for the pharmacovigilance system audit2021-05-25T00:04:09+03:00

The pharmacovigilance system inspection procedure

2021-05-25T00:02:34+03:00

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 [...]

The pharmacovigilance system inspection procedure2021-05-25T00:02:34+03:00

PROBLEM OF INSUFFICIENT INVOLVEMENT OF POPULATION INTO PHARMACOVIGILANCE SYSTEM

2021-05-24T23:34:52+03:00

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 [...]

PROBLEM OF INSUFFICIENT INVOLVEMENT OF POPULATION INTO PHARMACOVIGILANCE SYSTEM2021-05-24T23:34:52+03:00
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