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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 ...
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...
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 ...
An entry-level job is a job that is normally designed or designated for recent graduates of a given discipline and typically does not require prior experience in the field or profession. These roles may require some on-site training. Many entry-level jobs are part-time and do not include employee benefits.
An example of an application of informatics in medicine is bioimage informatics.. Dutch former professor of medical informatics Jan van Bemmel has described medical informatics as the theoretical and practical aspects of information processing and communication based on knowledge and experience derived from processes in medicine and health care.
Surveillance traditionally involved significant manual data assessment and entry in order to assess preventative actions such as isolation of patients with an infectious disease. Increasingly, computerized software solutions are becoming available that assess incoming risk messages from microbiology and other online sources.
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