Course
EudraVigilance Information Day
| Location: | EMA, Canary Wharf, London, UK |
|---|---|
| Date: | 19.10.2010 |
| End Date: | 19.10.2010 |
Description
The EudraVigilance Information Day will provide a forum for medicines regulatory authorities, marketing authorisation holders and sponsors of clinical trials to gain updates on the key activities of the EudraVigilance-Expert Working Group in line with their work programme for 2010 (see http://eudravigilance.emea.europa.eu) and the recent developments in pharmacovigilance and international standardisation. The detailed programmes will be made available several weeks before each EudraVigilance Information Day, the main areas that will be addressed are as follows: • Practical implementation questions from stakeholders with focus on electronic reporting of ICSRs, EudraVigilance data quality management and personal data protection • Recent developments and updates on the ICH topics E2B (electronic transmission of ICSRs), M5 (Identification of Medicinal Products), E2F (Development Safety Update Report -DSUR) and M1 (MedDRA) • Signal detection and risk management • New projects related to capacity and knowledge building in pharmacovigilance (e.g. ENCePP and IMI) • Description of pharmacovigilance systems of some national organisations Panel discussions will provide the opportunity for extensive Q&As with the speakers, chairpersons and Programme Committee members.Contact
DIA in Europe
http://www.diahome.org/
Tatjana.Topalovic@diaeurope.org