Transcription of ICH guideline E2F on development safety update report
{{id}} {{{paragraph}}}
Example: quiz answers
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 .. 4 Background .. 4 Objectives .. 4 Scope of the DSUR .. 5 Relation of the DSUR to the periodic safety update report .. 5 Recipients of the DSUR.
The DSUR should provide safety information from all ongoing clinical trials and other studies that the sponsor is conducting or has completed during the review period including: • Clinical trials using an investigational drug (i.e., human pharmacology, therapeutic exploratory and therapeutic confirmatory trials [Phase I – III]);
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: