Pre-approval clinical trials often fail to assess product safety and efficacy in pregnant women. Thus, there is a crucial need for post-approval research to understand product safety in this population. Observational safety studies of pregnant women exposed to products during pregnancy and their offspring are necessary to evaluate the risk of adverse pregnancy, fetal, and infant outcomes. These studies complement pre-approval clinical trial data and add to the body of evidence regarding the safety and effectiveness of the products. To achieve this objective, several types of real-world study designs can be implemented, all of which meet regulatory standards and supplement (not duplicate) existing vaccine surveillance systems. We’ll use COVID-19 vaccines as an example to demonstrate the importance of pregnancy safety studies, the need for flexible study solutions, and the best practices, benefits, and challenges associated with different study designs.

Discussion Points

This webinar will address:

  • The need for post-authorization safety studies in pregnant and lactating women and their offspring
  • The current landscape: regulatory requirements, existing registries and surveillance systems (e.g., vaccine surveillance systems), knowledge gaps, and challenges
  • Evidera’s flexible solutions
    1. Retrospective database studies
    2. Prospective registries and surveillance program
    3. Ambispective study designs
    4. Other study types, including lactation studies and placental transfer studies


  • Kristin Veley, PharmD, MPH, Research Scientist and Director, REMS and Pregnancy Registries, Non-Interventional Studies, Evidera
  • Jason Simeone, PhD, Senior Research Scientist and Director of US Database Analytics, Real-World Evidence, Evidera
  • Nicole Hurst, MSW, Senior Director Project Management, Real-World Evidence, Evidera