This webinar is FREE.
FDA is establishing a 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.
- Submission of IND safety reporting to FAERS
- Timelines and scope of the requirements for the new submission process
- Key ICH E2B data elements for submission of IND safety reports to FAERS
- Recognize that FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Event Reporting System (FAERS).
- Recognize that sponsors will be able to submit IND safety reports to FAERS either through the FDA Gateway or using the Safety Reporting Portal (web-based entry).
- Describe the E2B data elements that are key for IND safety reporting.
- Sponsors of commercial INDs
- Regulatory affairs professionals who submit IND safety reports
- Contract research organizations (CROs) who submit IND safety reports on behalf of sponsors of commercial INDs
Meredith Chuk, MD
Associate Director for Safety (Acting)
Office of Hematology and Oncology Products (OHOP) | CDER | FDA
Suranjan De, MS, MBA
Regulatory Science Staff (RSS) | Office of Surveillance & Epidemiology (OSE)| CDER | FDA