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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

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration
• approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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