Event Details

To continue the work of the BEST Initiative after the initial one-year contracts expire, CBER seeks to identify vendors that have the capability and capacity to provide new data sources, tools, and infrastructure to expand and enhance the current post-market surveillance system. CBER is announcing an Industry Day to be held on February 12, 2018 from 1 pm to 5 pm at the White Oak campus in Silver Spring, MD. The purpose of the Industry Day is for CBER to publicly communicate its requirements and provide an opportunity for the vendors to ask questions. Specifically, CBER will discuss an overview of its requirements and needs to build additional capacity for: 1) biologics post-market near real-time safety and effectiveness surveillance, 2) access to large sources of clinical patient-centered data particularly EHR, and 3) innovative approaches to conduct surveillance utilizing sophisticated query tools, machine learning, artificial intelligence, and natural language processing.