1st Information Day on the Development Safety Update Report (DSUR) Guidelines ICH E2F

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr... Course

Date(s) And Time(s):
Mar 23 2011 9:00AM - Mar 23 2011 5:00PM

Location:
European Medicines Agency
Canary Wharf, 7 Westferry Circus
London
E14 4HB
United Kingdom

Overview:

The new ICH guidelines E2F on the Development Safety Update Report (DSUR) has been signed off in August 2010 and will come into force in September 2011 in the European Economic Area (EEA). It is very likely that this report will replace the current Annual Safety Report on Clinical trials. This information day is intended to introduce the DSUR: its structure and content will be described and explained by the European experts who actively participate in the ICH E2F guidelines. Focus will be made on the practical issues based on the models for commercial and non commercial sponsors provided by the experts in charge of this topic in ICH. Finally some considerations will be discussed as to when and how this DSUR will be implemented in the EEA. A large place will be given to questions raised by the attendance during the panel discussion with all the speakers.

Event Code:
11579

Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH

4002 BASEL, SWITZERLAND

PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG