Background: Evidence about the safety of medical products in pregnant women relies heavily on observational data. However, it has been extremely challenging to create a sustainable and scalable infrastructure to support large-scale population-based surveillance of medical product safety in pregnancy. Numerous regional, national, and international efforts have attempted to create such a system, with varying degree of success.
Objectives: This workshop will describe recent efforts by the U.S. FDA in creating a new capability for a population-based surveillance of medical product use and safety in pregnancy within the Mini-Sentinel pilot project.
Description: The workshop will cover (1) FDA's regulatory need for monitoring the safety of medical products in pregnant women and how Mini-Sentinel can help support its regulatory mission, (2) a series of completed and ongoing activities in Mini-Sentinel designed to build a surveillance system for assessing medical product exposure and safety in pregnancy. We will describe the design of the system, accomplishments to date, challenges, and future directions.
