FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this round table discussion, the facilitators will discuss the implementation plan for E2B(R2) IND safety reporting for drugs and biologics at FDA.
Limit to 9 slots at each table.
Meredith Chuk, MD, MHS, Medical officer, OHOP, CDER, FDA
Suranjan De, Deputy Director, Regulatory Science, OSE, CDER, FDA