Transcription of ICH guideline E2F on development safety update report
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ICH guideline E2F on development safety update report
September 2011 EMA/CHMP/ICH/309348/2008 ICH guideline E2F on development safety update report Step 5 Transmission to CHMP June 2008 Adoption by CHMP for release for consultation June 2008 End of consultation (deadline for comments) December 2008 Final adoption by CHMP September 2010 Date for coming into effect September 2011 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. E2F development of safety update report Table of contents 1. Introduction.
Safety findings from non-interventional studies ... manufacturing changes, and overall development status and plans. To be broadly useful, the DSUR should also include this information, in ... the DSUR Executive Summary might be appropriate, supplemented with line listings of serious adverse reactions. 7 ...
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