Sections

Development Safety Update Report (DSUR)

Lindeq can advise you of DSUR compilation or also prepare your complete DSUR.

 

From September 2011 the Development Safety Update Report (DSUR) is the common standard for regular reporting on drugs under development as well as for marketed drugs that still are under further study. The DSUR, described in the ICH E2F guideline and adopted by the Committee for medicinal products for human use (CHMP) of EMA, replaces the EU Annual Safety Report (ASR) as well as the US IND Annual Report.
 
The format of the DSUR is designed to show early potential safety issues: it includes the current interpretation and management of risks to exposed patients, describes changes in the product’s safety profile and updates of the clinical development program.
 
In Lindeq we can advise you regarding the compilation of the report as well as prepare your complete DSUR. To learn more about your possibilities please contact us.
 

 

Document Actions