Date(s) And Time(s):
Jul 4 2011 9:00AM - Jul 4 2011 5:00PM
European Medicines Agency
Canary Wharf, 7 Westferry Circus
This is a repetition of the Information Day that took place on 23 March 2011.
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 new report will replace the current Annual Safety Report for clinical trials. This Information Day is intended to introduce the new DSUR concept. The structure and content will be described and explained by the European experts, who actively participated in the development of the ICH E2F guideline. Practical aspects based on DSUR examples for commercial and non-commercial sponsors will be presented. Finally, planning and organisational aspects will be discussed as to when and how the DSUR will be implemented in the EEA. Attendees will be provided with the opportunity to raise questions and to actively engage in the panel discussions with all the speakers.
Overview of the new ICH Guidelines E2F on the Development Safety Update Report (DSUR), which
is intended to be a common standard for periodic reporting on drugs under development (including
marketed drugs that are under further study).
Detailed format and content of the Development Safety Update Report (DSUR) and an outline of points
to be considered in its preparation and submission
DSUR Model for commercial and non-commercial sponsors providing practical examples on how to
prepare a DSUR
DSUR implementation in the European Union focusing on the preparation for the practical implementation
of the ICH E2F guideline
At the conclusion of this course, participants should be able to:
• Discuss the main principles defined in the ICH E2F guideline
• Describe the structure and content of the DSUR
• Discuss on how a DSUR can be prepared
• Prepare for the implementation of the DSUR
This programme will benefit:
Sponsors of Clinical Trials
EU Qualified Persons responsible for Pharmacovigilance (EU QPPVs)
Regulatory affairs staff of pharmaceutical companies
Pharmacovigilance staff of pharmaceutical companies and National Competent Authorities
Clinical Development staff
Payment of registration fees must be received before commencement of the event.
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52