Vaccine adverse event reporting

Executive Summary

CBER will hold a Sept. 27-29 workshop on "Harmonization of Reporting of Adverse Events Following Vaccination," FDA announces in Federal Register Aug. 12. The workshop will address systems used to process and monitor vaccine adverse event reports, requirements for surveillance databases, and standardized data- specific fields for worldwide dissemination of information. FDA said the workshop will assist CBER in preparing a guidance consistent with international programs. The workshop will be held at the Bethesda Holiday Inn, beginning at 8 a.m.