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Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient’s safety and the quality of life.
Adiba Nousheen +7 more
+7 more sources
Organisation of the Russian Pharmacovigilance System: Survey of Pharmacovigilance Officers
Ensuring the safety of pharmacotherapy is a priority of the national regulatory health policy and is enshrined in the international and federal legislation.
A. E. Krasheninnikov +2 more
doaj +1 more source
BackgroundAlbeit the need for sex-disaggregated results of adverse events after immunization (AEFIs) is gaining attention since the COVID-19 pandemic, studies with emphasis on sexual dimorphism in response to COVID-19 vaccination are relatively scarce ...
Janneke W. Duijster +8 more
doaj +1 more source
The World Health Organization (WHO) defines Pharmacovigilance as the science & activities relating to detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The National Pharmacovigilance Programme (NPVP) was launched in 2004 with World Bank funding till 2009, which was renamed as Pharmacovigilance
Shruti Brahmbhatt, Mahavirsingh Rajput
openaire +1 more source
An International Study of the Ability and Cost-Effectiveness of Advertising Methods to Facilitate Study Participant Self-Enrolment Into a Pilot Pharmacovigilance Study During Early Pregnancy [PDF]
Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance (PV) surveillance methods have important limitations.
Blackburn, SCF +11 more
core +14 more sources
Background Norovirus is an important cause of acute gastroenteritis globally. However, norovirus is rarely laboratory confirmed or recorded explicitly as a cause of hospitalization.
Elsa Negro-Calduch +2 more
doaj +1 more source
Audits and inspections of pharmacovigilance systems in Russia
The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as ...
A. A. Taube, B. K. Romanov
doaj +1 more source
How pharmacoepidemiology networks can manage distributed analyses to improve replicability and transparency and minimize bias [PDF]
Several pharmacoepidemiology networks have been developed over the past decade that use a distributed approach, implementing the same analysis at multiple data sites, to preserve privacy and minimize data sharing.
Brown, Jeffrey S. +5 more
core +2 more sources
Research Progress of Antitumor Pharmacovigilance
In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released.
Wenjuan SUN, Yang HU, Yan XU, Bo ZHANG
doaj +1 more source
Suvorexant (Belsomra® Tablets 10, 15, and 20 mg): Japanese Drug-Use Results Survey
Background We report on the results of a Japanese postmarketing drug-use survey of suvorexant (Belsomra®) tablets. Methods A survey with a ≤ 6-month observation period after the start of administration was conducted, targeting insomnia patients who were ...
Yuko Asai +5 more
doaj +1 more source

