Архивы Без категории - Страница 5 из 11 - Национальный научный центр Фармаконадзора

Управления рисками в фармаконадзоре

Елена Матвеева2021-11-07T13:32:47+03:00

Одним из важных и новых направлений фармаконадзора является управление рисками. Последнее подразумевает необходимость и возможность раннего выявления рисков, факторов, способствующих их возникновению, а также разработка мер по изучению и минимизации рисков, связанных с приемом лекарственных средств.Риск — это вероятность возникновения последствия чего-то. Термин «риск» не всегда, но, как-правило, указывает на нечто негативное. В случае лекарственных [...]

Управления рисками в фармаконадзореЕлена Матвеева2021-11-07T13:32:47+03:00

Gender characteristics of the development of adverse reactions of drugs used in dermatological practice
Gallery

Gender characteristics of the development of adverse reactions of drugs used in dermatological practice

Елена Матвеева2021-06-20T17:42:33+03:00

In 2019, the indicator of the frequency of skin diseases and subcutaneous fat in the residents of the Russian Federation was 5977 thousand people, which accounted for 5.2% of the total morbidity of the population. The causes of skin lesions can be external agents (fungal flora, bacteria, parasites, viruses, allergen exposure) and systemic disorders of [...]

Gender characteristics of the development of adverse reactions of drugs used in dermatological practiceЕлена Матвеева2021-06-20T17:42:33+03:00

The role of pharmacists in the organization of the pharmacovigilance system in the Republic of Kazakhstan
Gallery

The role of pharmacists in the organization of the pharmacovigilance system in the Republic of Kazakhstan

Елена Матвеева2021-06-20T17:21:55+03:00

Durmanova M.I., Krasheninnikov A.E., Safiullin R.S. This article is devoted to assessing the role of pharmacists in the pharmacovigilance system of the Republic of Kazakhstan. For this, the method of questioning the employees of pharmacy organizations was used, during which the insignificant role of pharmacists in the pharmacovigilance system of the Republic of Kazakhstan was [...]

The role of pharmacists in the organization of the pharmacovigilance system in the Republic of KazakhstanЕлена Матвеева2021-06-20T17:21:55+03:00

Clinical researches

Елена Матвеева2021-06-20T17:06:46+03:00

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 [...]

Clinical researchesЕлена Матвеева2021-06-20T17:06:46+03:00

Organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan
Gallery

Organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan

Елена Матвеева2021-06-20T17:07:17+03:00

Svechnikova E.V., Krasheninnikov A.E., Matveev A.V. For citation: Svechnikova E.V., Krasheninnikov A.E., Matveev A.V. Organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of Uzbekistan. – Vestnik Roszdravnadzora. – 2020. – Vol. 5(1). – P. 85–91.DOI: https://doi.org/10.35576/2070-7940-2020-5-1-85-91 This article is devoted to the study of the organization of pharmacovigilance at pharmaceutical enterprises of the [...]

Organization of post-marketing pharmacovigilance at pharmaceutical enterprises of the Republic of UzbekistanЕлена Матвеева2021-06-20T17:07:17+03:00

Formation of a pharmacovigilance base using a mobile application

Елена Матвеева2021-06-14T23:22:06+03:00

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 [...]

Formation of a pharmacovigilance base using a mobile applicationЕлена Матвеева2021-06-14T23:22:06+03:00

Digital channels for collecting data on adverse drug events

Елена Матвеева2021-06-20T17:12:06+03:00

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 [...]

Digital channels for collecting data on adverse drug eventsЕлена Матвеева2021-06-20T17:12:06+03:00

Information channels in the formation of the pharmacovigilance system

Елена Матвеева2021-06-10T23:23:53+03:00

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 [...]

Information channels in the formation of the pharmacovigilance systemЕлена Матвеева2021-06-10T23:23:53+03:00

Regulatory requirements for pharmacovigilance

Елена Матвеева2021-06-10T23:16:08+03:00

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 [...]

Regulatory requirements for pharmacovigilanceЕлена Матвеева2021-06-10T23:16:08+03:00

PHARMACOVIGILANCE AS AN EFFECTIVE TOOL IMPROVEMENT OF MANAGEMENT QUALITY OF PHARMACEUTICAL ACTIVITIES: STAGES OF DEVELOPMENT AND PROSPECTS

Елена Матвеева2021-06-10T22:59:09+03:00

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 [...]

PHARMACOVIGILANCE AS AN EFFECTIVE TOOL IMPROVEMENT OF MANAGEMENT QUALITY OF PHARMACEUTICAL ACTIVITIES: STAGES OF DEVELOPMENT AND PROSPECTSЕлена Матвеева2021-06-10T22:59:09+03:00