Pharmacovigilance in Russia: Challenges, Prospects and Current State of Affairs

Gildeeva, G. N.; Vi, Yurkov

doi:10.4172/2329-6887.1000206

Cited by 3 publications

(2 citation statements)

References 2 publications

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“…Эти сообщения направляются в базу данных «Фармаконадзор» Росздравнадзора различными категориями респондентов (клинические фармакологи, представители фармацевтических компаний, представители региональных подразделений Росздравнадзора и др.) [1,4,6,7]. Традиционно наиболее качественная информация в спонтанных сообщениях поступает от профильных специалистов -клинических фармакологов и провизоров Региональных центров мониторинга безопасности ЛС (РЦМБЛС).…”

Section: материалы и методыunclassified

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Assessment of Pharmacovigilance Reporting in Russia

Олефир

Романов

Аляутдин

et al. 2018

Bezopasnost' i risk farmakoterapii

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The risk-based approach to pharmacovigilance control implemented in Russia since January 1, 2018 increases the responsibility of manufacturers and developers of medicines. The purpose of the work is to assess the system of Express reporting and Periodic reporting on the safety of drugs in accordance with the relevant requirements of the legislation of the Russian Federation and the Eurasian Economic Union. The article continues a series of publications on recommendations for the preparation of reporting forms on pharmacovigilance. The article presents the results of the assessment of the state of elements of the system of drug safety control in Russia in terms of the preparation of reporting forms in accordance with the current regulatory requirements of national and international legislation for holders of registration certificates of medicines for medical use and developers of medicines. Recommendations for proper preparation of periodic reporting are proposed. The range of problems requiring additional assessment, in particular, the state of the system of regional centers for monitoring the safety of medicines in Russia is highlighted. The article is addressed to clinical pharmacologists, pharmacovigil commissioners, pharmacovigilance specialists, heads of medical and pharmaceutical organizations and medical authors.

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Section: материалы и методыunclassified

“…Подготовка экспресс-отчетности и периодической отчетности по безопасности лекарственного средства ( разработчиком ЛС в базу данных «Фармаконадзор» Росздравнадзора [1][2][3][4][5].…”

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Assessment of Pharmacovigilance Reporting in Russia

Олефир

Романов

Аляутдин

et al. 2018

Bezopasnost' i risk farmakoterapii

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Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System

Gildeeva¹,

Av²

2017

Pharmaceut Reg Affairs

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Pharmacovigilance Safety Monitoring in Clinical Trials

Nikam¹,

Jambhulkar²,

Kayande³

et al. 2021

IJPSRR

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Pharmacovigilance is that the science and activities associated with the gathering, detection and assessment of adverse event data. Major purpose of pharmacovigilance is to gauge the benefit- risk profile of drug for better efficacy and safety to be used in patients. Pharmacovigilance plays a major role in rationale use of drug which provides the information about the adverse drug reactions which seen in patients. In terms of volume Indian Pharma industry is third largest in world and in terms of value id thirteen largest in world. India is also known as a hub for clinical research and drug development. There is a requirement of a global and standardized pharmacovigilance system in India for better safety assessment in India. In drug development process the only priority of clinical trials is to make sure patient safety during and after the trials. A critical component throughout the drug development life-cycle is monitoring patient safety. Patient must be treated consistent with the requirements and illness of patient therefore the utmost value is given to monitoring of patient safety in the least levels of drug development. Such monitoring may be a dynamic process so to approach safety monitoring. To ensure a systematic approach to safety monitoring pharmaceutical sponsor must work proactively and collaboratively with all stakeholders. We have to focus upon all the aspects of drug safety in clinical trials including basics of drug safety, regulatory aspects of drug safety, patient suitability for safety in trials, post marketing safety and causality risk assessment of the drug products.

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Pharmacovigilance in Russia: Challenges, Prospects and Current State of Affairs

Cited by 3 publications

References 2 publications

Assessment of Pharmacovigilance Reporting in Russia

Assessment of Pharmacovigilance Reporting in Russia

Pharmacovigilance in the Russian Federation: Construction, Development and Reforms of PV System

Pharmacovigilance Safety Monitoring in Clinical Trials

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