2020
DOI: 10.1177/2042098620909614
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Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance

Abstract: Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports. The cumulative information, obtained from these reports, can be used to assist pharmacovigilance professionals in the detection of potential safe… Show more

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Cited by 21 publications
(15 citation statements)
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“…In this study, the percentage of changes made in both countries within 30 days was low at 7.5% and some of the safety label changes had a time lag over 2 years. Pharmacovigilance is a field in which communication is very crucial, and the exchange of information is expected to be done in a timely manner 20 . Nowadays there is a recognized need for competent and rapid communication between national drug regulatory centers as well as to other countries 21 .…”
Section: Discussionmentioning
confidence: 99%
“…In this study, the percentage of changes made in both countries within 30 days was low at 7.5% and some of the safety label changes had a time lag over 2 years. Pharmacovigilance is a field in which communication is very crucial, and the exchange of information is expected to be done in a timely manner 20 . Nowadays there is a recognized need for competent and rapid communication between national drug regulatory centers as well as to other countries 21 .…”
Section: Discussionmentioning
confidence: 99%
“…For example, postmarketing reporting by HCPs may lack sufficient information to adjudicate AE causality or relationship to drug, creating uncertainty over whether the reported event could be considered drug related. 21 , 27 In unsolicited AE reporting, causality is assumed, not assessed, 64 , 65 and follow-up reports are not required unless new information arises, 65 making it challenging to determine causality if the information provided is incomplete or confounded. 2 When AEs are reported, the lack of standardized definitions used for postmarketing reporting by HCPs 36 and unverified information in these reports 27 may contribute to inaccuracies within the reports.…”
Section: Limitations To the Pharmacovigilance Systemmentioning
confidence: 99%
“…These still need to be processed and evaluated, according to the strict regulations in place, with a risk of taking the focus away from ICSRs with pharmacovigilance utility that is with the most likely to further understanding of the risk-benefit balance. • Reporting regulations are evolving and extending around the world [92][93][94], but a harmonised approach is not always seen, leading to increased workload. One might reasonably ask whether there is always a compelling link between changes to safety regulation and the accompanying efforts need to assure compliance [95] and their capability to further patient safety.…”
Section: Data Fusion and Linkage To Other Datamentioning
confidence: 99%