EudraVigilance Information Day

6 October 2008, Canary Wharf, United Kingdom

Introduction

The electronic transmission of ICSRs is a key element in improving the process of adverse reaction reporting in pharmacovigilance. It is not only a major step forward in providing information more rapidly but also in standardizing the way clinical safety data elements are presented, thereby improving the collective ability to evaluate complex data. The programme will address the latest status in the EEA regarding the electronic reporting initiatives from Regulator and Industry perspectives.