Virtual | Virtual

Event Title

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

January 13, 2023

Date:: January 13, 2023
Time:: 11:00 AM - 12:00 PM ET

Topic & Presentation	Speaker
Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
Reporting Premarket and Postmarket Safety Reports to FDA Using ICH E2B(R3) Standards	Suranjan De, MS, MBA Regulatory Science Staff Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) \| US FDA
Q&A Session	Suranjan De

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ABOUT THIS WEBINAR

Sponsors of clinical trials conducted under an investigational new drug (IND) application are required to report serious and unexpected suspected adverse reactions in an IND safety report to the FDA and participating investigators within 7 or 15 days depending on the type of event (21 CFR §312.32). Sponsors conducting an IND-exempt bioavailability/bioequivalence (BA/BE) study must notify FDA of any serious adverse event (21 CFR §320.31 (d)(3)) within 7 or 15 days depending on the type of event. The current required process for submission and review of IND and IND-exempt BA/BE safety reports submitted to the FDA as PDF files or on paper is inefficient, labor intensive, and poses challenges for safety signal detection and tracking.

FDA will eventually require certain IND safety reports, postmarket safety reports and allow IND-exempt BA/BE safety reports to be submitted to FDA Adverse Events Reports System (FAERS) in ICH E2B (R3) format which will enable improved analysis, visualization, and tracking of this important safety data.

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. Additionally, discuss the two separate submission methods and paths (FDA Gateway or the web-based Safety Reporting Portal) for submission to FAERS.

TOPICS COVERED

Regional technical specification and implementation process for receiving safety reports to FAERS using ICH E2B (R3) and regional data elements
Regional E2B data elements for premarket and postmarket safety reporting
Submission methods and paths (FDA Gateway or the web-based Safety Reporting Portal) for submission to FAERS and testing methods

INTENDED AUDIENCE

Regulatory science and regulatory affairs professionals working on submission of safety reports for both premarket and postmarket to FDA
Consultants focused on implementing the submission of safety reports for both premarket and postmarket to FDA using E2BR3 standards
Clinical research coordinators responsible for the submission of safety reports for both premarket and postmarket to FDA
Technical experts focused on implementing the submission of safety reports for both premarket and postmarket to FDA using E2BR3 standards

FDA SPEAKERS

Suranjan De, MS, MBA
Regulatory Science Staff
Office of Surveillance and Epidemiology (OSE)
Center for Drug Evaluation and Research (CDER) | US FDA

FDA RESOURCES

FDA Adverse Event Reporting System (FAERS) Electronic Submissions

Event Materials

Title	File Type/Size
Reporting premarket and postmarket safety reports to FDA using ICH E2B(R3) standard - January 13, 2023	pdf (3.18 MB)