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
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion.
- is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- ACRP provides research-specific continuing education for the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material
- Continuing education certificates are available only for those who attend in-person or via webcast in real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
- This course is eligible for 1 CE credit for physicians, nurses, pharmacists, or pharmacy technicians. Please refer to the course CE Announcement for complete information.
- FAERS website
- Webcast videos, presentations, and transcripts from the March 25, 2019, and July 17, 2019, public meetings.
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