Second information day on the new individual case safety report (ICSR) international standard and ICH E2B/M2
Event
Date
- Tuesday, 5 April 2011, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
Changes to the individual case safety report (ICSR) final draft international standard (FDIS) are being presented and explained at this information day, as well as the key aspects of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICSR implementation guide. Furthermore, expected changes to ICSR reporting in the context of the new pharmacovigilance legislation are being discussed. Registration open until 4 April 2011. Places limited.