Drug Safety/Pharmacovigilance

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

International Conference on Harmonisation (ICH) has defined E2B as the international standard for transmitting medicine adverse event reports. The ICH E2B document includes message standards required for effective transmission of individual case safety reports (ICSR).

Clinical Marketed Individual Case Safety Reports

Individual Case Study Report (ICSR) is an adverse event report for an individual patient and is source of data in pharmacovigilance. The main focus of ICSRs are reports from healthcare providers and patients in member countries of the WHO Programme.

Expedited reporting. ... In most countries, the timeframe for reporting expedited cases is 7/15 calendar days from the time a drug company receives notification (referred to as "Day 0") of such a case. Within clinical trials such a case is referred to as a SUSAR (a Suspected Unexpected Serious Adverse Reaction)

Aggregate Safety Reports

Periodic Safety Update Reports (PSURs) and Addendums to Clinical Overviews (ACOs) are safety reports which aim to present a critical evaluation of the risk/benefit profile of a product and are considered to reflect the worldwide safety experience of a specific medicinal product.

Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports.