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Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. [1]: 7 The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep ...
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The approval of the Pfizer-BioNTech vaccine was extended to young people aged 12–15 in June 2021, [31] 5–11 in December 2021, [32] and from six months in December 2022. [33] The status of the Oxford / AstraZeneca vaccine was upgraded to conditional marketing authorisation on 24 June 2021. [28]
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
The WHODrug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre.
The agency is composed of the Secretariat (ca. 600 staff), a management board, seven scientific committees (human, veterinary and herbal medicinal products, orphan drugs, paediatrics, advanced therapies and pharmacovigilance risk assessment) and a number of scientific working parties.
Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance.
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.