Module IX – Signal management.pdf

22 June 2012 EMA/827661/2011 Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management Draft finalised by the Agency in collaboration with Member States and 19 January 2012 submitted to ERMS FG Draft agreed by ERMS FG 24 January 2012 Draft adopted by Executive Director 20 February 2012 Released for consultation 21 February 2012 End of consultation (deadline for comments) 18 April 2012 Revised draft finalised by the Agency in collaboration with Member 20 June 2012 States Revised draft agreed by ERMS FG 21 June 2012 Revised draft adopted by Executive Director as final 22 June 2012 Date for coming into effect 2 July 2012 See websites for contact details European Medicines Agency www.ema.europa.eu The European Medicines Agency is Heads of Medicines Agencies www.hma.eu an agency of the European Union © European Medicines Agency and Heads of Medicines Agencies, 2012. Reproduction is authorised provided the source is acknowledged. Table of contents IX.A. Introduction 3 IX.B. Structures and processes 4 IX.B.1. Sources of data and information 4 IX.B.2. Methodology for signal detection 4 IX.B.3. The signal management process 5 IX.B.3.1. Introduction5 IX.B.3.2. Signal detection 5 IX.B.3.2.1. Review of individual case sa