1st Information Day on the Development Safety Update Report (DSUR) Guidelines ICH E2F
Venue: European Medicines Agency
Location: London, United Kingdom
Event Date/Time: Jul 04, 2011 |
Description
Key Topics
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
Learning Objectives:
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
Target Audience:
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
Event Code:
11591