92 9036 074 7_c06b209b

Current Challenges in Pharmacovigilance: Pragmatic Approaches – Report of CIOMS Working Group V

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ISBN: 92 9036 074 7
Year of publication: 2001
Number of pages: 381
Author: CIOMS
CIOMS licence for electronic versions of its publications: Download
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The CIOMS V Working Group (WG) met in a series of 8 formal meetings during the years 1997 to 2000. The printed version of their report” Current Challenges in Pharmacovigilance: Pragmatic Approaches” was published in 2001.

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The CIOMS V Working Group (WG) met in a series of 8 formal meetings during the years 1997 to 2000. The printed version of their report” Current Challenges in Pharmacovigilance: Pragmatic Approaches” was published in 2001. The CIOMS WG V, through its report,  advocated acceptance for a wide range of proposals concerning issues covering terminology and definitions, common every-day practices such as follow-up of individual adverse events, the rational scheduling and content of periodic safety update reports (PSURs), the role of Internet and quantification of population drug use.The completed report, intended as a handbook for pharmacovigilance departments and still offering many pragmatic solutions to a number of issues, has been in great demand. CIOMS has now decided to make the publication available free of charge to download on its website.