Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)- Nov. 1, 2019

Dr. Meredith Chuk from CDER’s Office of Hematology and Oncology Products and Suranjan De from CDER’s Office of Surveillance & Epidemiology discuss FDA’s new submission process for investigational new drug (IND) safety reports. Submission of this important safety information as structured data will improve FDA’s ability to review and track safety signals that occur during the conduct of clinical trials. It will also provide sponsors with a reporting format which is consistent with International Council for Harmonisation (ICH) data standards and reporting to other regulatory agencies. This webinar will describe the new submission process, timelines and scope of the requirements, and E2B data elements that are key for pre-market safety reporting.
Find more information at www.fda.gov/dr...
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