Transcription of Draft Guideline Use Statistical Signal Detection Methods ...
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Draft Guideline Use Statistical Signal Detection Methods ...
European Medicines Agency Evaluation of Medicines for Human Use London, 16 November 2006 Doc. Ref. EMEA/106464/2006 Draft AGREED BY EV EWG 23 May 2006 ADOPTION BY EUDRAVIGILANCE STEERING COMMITTEE 12 June 2006 ADOPTION BY CHMP-PHARMACOVIGILANCE WORKING PARTY 20 September 2006 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 16 November 2006 END OF CONSULTATION (DEADLINE FOR COMMENTS) 16 May 2007 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorized for non commercial purposes only provided the EMEA is acknowledged KEYWORDS EudraVigilance, Signal Detection , Quantitative Signal Detection Methods , Proportional reporting ratio, Risk management Comments should be provided to Fax +44 20 7418 8668 Guideline ON THE USE OF Statistical Signal Detection Methods IN THE EUDRAVIGILANCE DATA ANALYSIS SYSTEM EUDRAVIGILANCE EXPERT WORKING GROUP (EV-EWG) EMEA 2006 2/21 TABLE OF CONTENTS EXECUTIVE SUMMARY.
Data Analysis System integrates statistical methods with traditional methods used in pharmacovigilance. This guideline also recognises that there are specific aspects on the use of quantitative methods for the detection of potential signals …
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