The purpose of this webinar is to provide information on the plans, progress, and technical specifications on enhancements to electronic submission of premarket and postmarket Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. This webinar will enhance the pharmaceutical industry’s knowledge of the processes needed to implement ICH E2B(R3) into their systems.
We encourage our participants to review the webcast videos, presentations, and transcripts from the March 25, 2019, and July 17, 2019, public meetings ahead of time.
- FAERS II and E2B R3 Up Versioning Plans
- Describe the objective, scope and timeline of E2B R3 regional implementation
- E2B(R3) Regional Data Elements
- Premarket safety reporting regional requirements
- Postmarket safety reporting regional requirements
- Postmarket combination product regional requirements
- Updates on electronic submission routing mechanisms
- Describe the different routing mechanisms to submit via ESG or Safety Reporting Portal
- Testing ICH E2B (R3) Regional XML files
- Describe the methods to test ICH E2B (R3) regional XMLs
- Pharmacovigilance experts focused on implementing safety databases and submitting safety reports to regulatory agencies
- Regulatory affairs professionals who submit premarket safety reports
- Consultants working to implement ICH E2B (R3) standards
Suranjan De, MS, MBA
Regulatory Science Staff (RSS) | Office of Surveillance & Epidemiology | CDER | FDA
- Understand FDA’s regional data elements for the implementation of ICH E2B(R3).
- Enhance the pharmaceutical industry’s knowledge of the processes needed to implement ICH E2B(R3) and regional data elements into their systems.