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In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No ...
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 ...
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
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.
In June 2018, the company acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory issues for biopharmaceutical and medical devices clients. [44] [45] [46] In August 2018, Covance Food Solutions was sold to Eurofins Scientific for $670 million. [47] [48] [49]
A study of workers in 27 countries surveyed in mid-2021 and early 2022 found they would on average be willing to sacrifice 5% of their pay to be able to work from home two to three days per week. 26% would quit immediately or seek a new job if they were required to work five or more days per week. [34]
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