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Literature review pharmacovigilance

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The pharmacovigilance legislation, which came into effect in July , was the biggest change to the regulation of human medicines in the European Union EU since It had significant implications for applicants and holders of EU marketing authorisations , as well as for patients, healthcare professionals and regulators. The development of the pharmacovigilance legislation was based on the observation that adverse drug reactions ADRs , 'noxious and unintended' responses to a medicine, caused around , deaths per year in the EU. Because of this, in the European Commission began a review of the European system of safety monitoring including sponsoring an independent study, as well as extensive public consultation through and
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Medical literature monitoring

Literature review pharmacovigilance
Literature review pharmacovigilance
Literature review pharmacovigilance
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Pharmacovigilance literature review in the age of precision medicine | Arthur D Little

Metrics details. A Correction to this article was published on 12 September The novel coronavirus pandemic calls for a rapid adaptation of conventional medical practices to meet the evolving needs of such vulnerable patients. People with coronavirus disease COVID may frequently require treatment with psychotropic medications, but are at the same time at higher risk for safety issues because of the complex underlying medical condition and the potential interaction with medical treatments. In order to produce evidence-based practical recommendations on the optimal management of psychotropic medications in people with COVID, an international, multi-disciplinary working group was established.
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Pharmacovigilance: literature monitoring

For half a century, a high level of total cholesterol TC or low-density lipoprotein cholesterol LDL-C has been considered to be the major cause of atherosclerosis and cardiovascular disease CVD , and statin treatment has been widely promoted for cardiovascular prevention. However, there is an increasing understanding that the mechanisms are more complicated and that statin treatment, in particular when used as primary prevention, is of doubtful benefit. Areas covered: The authors of three large reviews recently published by statin advocates have attempted to validate the current dogma.
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Pharmacovigilance PV or PhV , also known as drug safety , is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions , or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy the condition that this definition only applies with the doses normally used for the prophylaxis , diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation. Information received from patients and healthcare providers via pharmacovigilance agreements PVAs , as well as other sources such as the medical literature , plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder usually a pharmaceutical company must be submitted to the local drug regulatory authority. See Adverse event reporting below.
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