Guidelines for Setting up and Running a Pharmacovigilance Centre

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This guide of 25 pages is a good basic text for learning about pharmacovigilance.

Why pharmacovigilance?
How to start a Pharmacovigilance Centre
Reporting of adverse drug reactions - by whom? - What to report? - Mandatory or voluntary reporting?
Reporting issues - Central or decentralised reporting? - Stimulation of reporting - Under-reporting
Practicalities in the organisation of a pharmacovigilance centre
Assessment of case reports
Use of the data
Relations with other agencies
Other sources of information

It is available for download here in English, French, Spanish, Portuguese and Russian (all as pdf):

English version (341 Kb) 
French version (110 Kb)
Spanish version (115 Kb)
Portuguese version (575 Kb)
Russian version (473 Kb)

Contact for a printed copy.
A limited number of copies are also available in Italian and in Korean.


Guidelines for setting up... page last updated 5 September 2011


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