Transcription of ICH guideline E2F on development safety update report
{{id}} {{{paragraph}}}
Example: tourism industry
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.
Both the DSUR and PSUR should be comprehensive and stand alone as they focus on different subject matter and have differing periodicities and recipients. 1.5. Recipients of the DSUR . The DSUR is intended to serve as an annual report to regulatory authorities. Where …
Loading..
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: