Learning Objectives for this Presentation:
1.Describe the need for standardized case definitions and guidelines in the assessment of adverse events following immunization (AEFI)
2.Explain how to access the Brighton Collaboration website to download standardized case definitions and guidelines for AEFI
3.Describe the usefulness of using standardized case definitions in validating reports of AEFI.

Background:
The Brighton Collaboration is an international voluntary organization that was formed primarily to develop globally accepted and standardized case definitions and guidelines for vaccine safety data. Since its beginnings in 2000, the Brighton Collaboration has grown rapidly and has developed an established process. This work constitutes the first structured effort to build international consensus on a “common language” or “vocabulary” needed for further scientific understanding of vaccine safety. The use of these definitions is recommended by key int
Objectives:
.Describe the need for standardized case definitions and guidelines in the assessment of adverse events following immunization (AEFI)
2.Explain how to access the Brighton website to download standardized case definitions and guidelines for AEFI
3.Describe the usefulness of using standardized case definitions in validating reports of AEFI.
Methods:
Setting:
Various stakeholders interested in immunization safety including participants from public health, regulatory, academic, clinical care, and vaccine-manufacturing backgrounds
Results:
Scientific communities that study vaccine safety through pre,- and post-licensure surveillance and clinical trials can use the Brighton case definitions and guidelines.
Project description:
The standardized definitions and guidelines are intended to serve as a tool to investigators of pre,- and post-licensure vaccine safety studies to aid in the development of study protocols and data collection forms, and to enable standardized assessment and presentation of vaccine safety data. This is a global effort to harmonize adverse event reporting.
Conclusions:
Standardization of adverse event reporting following immunization facilitates comparability and evidence-based communication of vaccine safety data. This plays a key role in the enhancement of trust in current immunization programs.