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Practical Aspects of Signal Detection in Pharmacovigilance

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Geneva 2010CIOMS Practical Aspects of Signal Detection in Pharmacovigilance 2010CIOMS publications may be obtained directly from CIOMS, c/o World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland or by e-mail to CIOMS and WHO publications are distributed by the World Health Organization, Marketing and Dissemination, Avenue Appia, 1211 Geneva 27, Switzerland and are available from booksellers through the network of WHO sales list of these agents may be obtained from WHO by writing to the above of SignalDetection inPharmacovigilanceReport of CIOMS Working Group 11 11:11PRACTICAL Aspects OF Signal Detection IN PHARMACOVIGILANCEReport of CIOMS Working Group VIIIGeneva

includes signal detection, signal prioritization, and signal evaluation. If the evalua-tion of a drug safety signal establishes a new adverse drug reaction, then this stage of the signal’s lifecycle will lead to an update of the product’s prescribing information

  Signal

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