The Food and Drug Administration (FDA) has announced a public workshop titled “The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.” The purpose of the workshop is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA’s regulatory review process and case examples), and discuss the future direction of PRISM in terms of expansion and further integration into the regulatory review process.
The workshop will bring together other government agencies, academia, industry, and other stakeholder participants involved in vaccine development and safety. The goal of the workshop is to present and discuss the current capabilities of PRISM. Topics include: (1) The available data infrastructure, (2) methods, and (3) tools. In addition, a few representative examples of PRISM studies will be presented to demonstrate the program’s success in safety signal refinement and evaluation and informing the regulatory process. There will also be a discussion of possible future directions for PRISM.
Details for the workshop are as follows:
- Wednesday, December 7, 2016; 8:30 am to 5 pm
- National Institutes of Health, Lister Hill Center Auditorium
- 8600 Rockville Pike, Building 38A, Bethesda, MD 20894