Vigilance Agreement Deutsch

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science regarding the collection, detection, evaluation, monitoring and prevention of adverse reactions with pharmaceuticals. [1] The etymological roots of the word “pharmacovigilance” are: pharmakon (Greek for drugs) and vigilare (Latin for remaining vigilant). AE reports appear when patients (subjects, participants) witness any “adverse” event while conducting clinical trials. Non-serious adverse events are usually recorded separately at a lower level than pharmacovigilance. AE and SAE information, which may also contain relevant information from the patient`s medical history, is checked and evaluated by the examiner for both causality and severity. This information is passed on to a sponsoring company (usually a pharmaceutical company or academic medical center) responsible for reporting this information to the drug supervisory authorities. The activity most frequently associated with pharmacovigilance (PV) and which consumes a significant amount of resources for drug regulatory authorities (or similar government agencies) and drug safety services in pharmaceutical companies is the reporting of adverse events. Adverse event (AE) reporting includes receiving, triage, data entry, assessment, distribution, reporting (if applicable) and archiving of AE data and documentation. The source of AE reports may be: spontaneous reports from healthcare professionals or patients (or other intermediaries); requested reports from patient support programs; reports of clinical or post-marketing trials; reports from literary sources; information from the media (including social media and websites); and reports notified to the pharmaceutical authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. The AE report also provides these companies and drug supervisors with data that play a key role in assessing the risk-benefit profile of a given drug. Several facets of the AE report should be indicated below: all AEDS must be part of the MAH quality management system and the letter, approval and documentation of each AEDS and any type of AEDS must be tracked and verifiable by the company`s SOPs.

This is a regulatory requirement and AEDS are inspected during pharmacovigilance inspections and audits. In Kenya, PV is regulated by the Pharmacy and Poisons Board. The Pharmacy and Poisons Board provides an electronic pharmacovigilance system to report suspected adverse reactions and suspected poor quality of medicines online. [42] Pharmacovigilance activities in Kenya are supported by the School of Pharmacy at the University of Nairobi through the Master of Pharmacy in Pharmacoepidemiology & Pharmacovigilance programme, offered by the Department of Pharmacology and Pharmacognosy. [43] Pharmacovigilance databases are an increasingly popular approach with the availability of extensive data sources and inexpensive computational resources. . . .

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