FDA Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B
Venue: Hilton Alexandria Old Town
|Event Date/Time: May 12, 2011||End Date/Time: May 13, 2011|
ICH proposed to use this standard to meet the reporting requirements for E2B(R3). ICH will define the way that this standard should be used by the publication of an ICH Implementation Guide, which will define the use of the data elements as outlined in the E2B(R3) guideline. In addition, a harmonized approach to ensure backwards and forwards compatibility between the current ICH ICSR message specifications and the new standard â€“ a major aspect during the transition phase until all stakeholders have upgraded their pharmacovigilance systems â€“ will be addressed in the Implementation Guide.
This day and a half workshop will explore how a single, common standard for the ICSR could be advanced.