Definition of Terms for Vaccine Pharmacovigilance

Report of CIOMS/WHO Working Group on Pharmacovigilance

May 2012
More details
  • Publisher
    World Health Organization
  • Published
    8th May 2012
  • ISBN 9789290360834
  • Language English
  • Pages 182 pp.

This report from the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010).

This 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 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 familiarize themselves with vaccine safety terminology.

Council for International Organizations of Medical Sciences (CIOMS)

Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. In 2009 CIOMS celebrated the 60th anniversary of its creation. Through its membership, CIOMS is representative of a substantial proportion of the biomedical scientific community. In 2013, the membership of CIOMS included 49 international, national and associate member organizations, representing many of the biomedical disciplines, national academies of sciences and medical research councils.