Definition and Application of Terms for Vaccine Pharmacovigilance

Overview

This publication is jointly supported by CIOMS and WHO and can be regarded as a specifi c contribution to a series of CIOMS Working Groups on Drug Safety, in this particular case Vaccine Safety. Previous working groups have established the CIOMS reporting form for cases of adverse reactions, set standards for periodic safety update reports (PSURs), devel-oped proposals for harmonized safety information of data sheets or pack-age inserts, presented approaches for assessing benefi t-risk, discussed as-pects of day-to-day pharmacovigilance work affecting management and interpretation of safety data, management of safety information in clinical trials and standards for the development of safety update reports. Recently, the practical aspects of signal detection were published.