European Medicines Agency , London, UK
Jul 4 2011 9:00AM - 5:00PM
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. Payment of registration fees must be received before commencement of the event. Event Code:
11591
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