Tutorials are not included in the meeting registration and require a separate registration fee.

This half-day tutorial will provide an overview and lessons learned regarding the submission and evaluation of postmarketing case safety reports in electronic format to the FAERS database, both through the “database-to-database” E2B process, and through the Safety Reporting Portal (SRP). The tutorial will then discuss specific data quality issues with an in-depth focus on suspect product identification and on submitted MedDRA coding for adverse events and medication errors. Additionally, an update on the status of the E2B(R3) Technical Specifications Document and electronic vaccine case reporting (VAERS) shall be presented.

Lunch will not be provided for a half day tutorial.