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ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)
Session Chair(s)
Meredith K. Chuk, MD, MHS
Acting Associate Director for Safety, OOD, OND, CDER
FDA, United States
FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this session the implementation plan for E2B(R2) IND safety reporting will be discussed in use case-based scenarios.
Learning Objective : Recognize that FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Event Reporting System (FAERS); Describe several E2B R2 data elements, including regional elements that are key for premarket safety reporting.
Speaker(s)
Facilitator
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER