FDA Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B

Venue: Hilton Alexandria Old Town

Location: Alexandria, Virginia, United States

Event Date/Time: May 12, 2011 End Date/Time: May 13, 2011
Report as Spam


In May 2005, the revised ICH Guideline for Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) (E2B(R3)) was released for public consultation. The ICH Steering Committee decided that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs) to enable wider interoperability across the regulatory and health care communities. The ICSR is the first topic to go through this process. ICH representatives have been heavily involved in this initiative in addition to other experts from beyond the ICH community. The overall standard is based upon the HL7 ICSR model that is capable of supporting a wide range of product types (e.g., human medicinal products, veterinary products, medical devices, etc.)

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 – a major aspect during the transition phase until all stakeholders have upgraded their pharmacovigilance systems – 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.

Event Code: