DIA, in collaboration with US FDA and EMA will host FDA Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B from May 12-13 in Alexandria, VA.
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.).
This two-day workshop will explore how a single, common standard for the ICSR could be advanced. Session topics include:
- Status of International Standardization of Clinical Safety Data Management
- Current ICH E2B(R2) Guideline and the HL7 Message Specifi cations
- How to Adapt the New ICSR Standard to Your Pharmacovigilance Systems
“ICH will define the way the new 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,” says Gaby L. Danan, GLD Conseil, Pharmacovigilance Expert and member of the program committee. “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.”
Register for FDA Information Day: The New Individual Case Safety Report (ICSR) International Standard and ICH E2B
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