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Session 4: FDA: Digital IND Safety Reporting
Session Chair(s)
Ginny Hussong
Branch Chief, Data Standards, CBER
FDA, United States
This session will provide an FDA overview and update on the new FDA Digital IND Safety initiative, which will require industry to submit IND Safety Reports in ICH E2B format directly to FAERS, and no longer within an eCTD submission. Panelists will discuss the related binding guidance for industry and technical conformance guide, including which submission types are included in the requirement, steps FDA has taken to pilot and test the new submission process, and submission pathways sponsors may choose.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Evaluate the goals of the IND Safety Reporting initiative
- Describe FDA’s approach to digital IND Safety Reporting
- Identify how IND Safety Reporting will impact sponsors
Speaker(s)
FDA’s Implementation of Digital IND Safety
Meredith K. Chuk, MD, MHS
FDA, United States
Acting Associate Director for Safety, OOD, OND, CDER
FAERS II Status Update for IND Safety
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
Safety Reporting Portal Update
Vali Tschirgi
FDA, United States
Project Manager, CBER