Grateful to the members of cioms working group v on current challenges in pharmacovigilance pragmatic approaches and to the drug regulatory authorities pharmaceutical companies and other organizations represented for their patience and hard work in bringing this project to its successful conclusion special thanks are due to the co chairs. 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 v working group has generated proposals for pragmatic approaches to dealing with such issues as classification and handling of individual safety case reports from a variety of sources spontaneous consumer reports solicited reports literature the internet observational studies and secondary data bases disease and other . Current challenges in pharmacovigilance pragmatic approaches report of cioms working group v council for international organizations of medical sciences cioms 2001 isbn 92 9036 0747. Current challenges in pharmacovigilance pragmatic approaches cioms v development and rational use of standardised meddra queries smqs management of safety information from clinical trials cioms vi development safety update reports cioms vii cioms and pharmacovigilance
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