Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards

14 November 2022 – the FDA announced a webinar on 13 January 2023 to discuss standards for reporting ICSRs to FAERS.

This session will describe the regional technical specification and implementation process for receiving safety reports to FAERS using ICH E2B (R3) and regional data elements. The session will include a discussion of regional E2B data elements for premarket and postmarket safety reporting and provisions for submission of safety reports to FAERS that satisfy requirements for safety reporting regulations and FDA Guidance.