Definitions and Applications of Terms for Vaccine Pharmacovigilance


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ISBN: 9789290360834
Year of publication: 2012
Number of pages: 193
CIOMS licence for electronic versions of its publications: Download
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The Council for International Organizations of Medical Sciences (CIOMS) is happy to announce a new publication in collaboration with WHO. This report covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010) and is published in its full version as a PDF file on the websites of CIOMS and WHO.

The working group brought together experts from both industrialized and emerging countries representing regulatory agencies, vaccine industry, national and international public health bodies including WHO and CIOMS, academia and clinical care, contributing from their different perspectives.

The working group’s report covers general terms and definitions for vaccine safety and discusses the application of such harmonized tools in vaccine safety surveillance and studies. As well, the report highlights case definitions for adverse events typically reported for vaccines.

The report is addressed to those engaged in vaccine safety data collection and evaluation, and will also make a useful reading for others who want to familiarise themselves with vaccine safety terminology.