To address the FDA’s 2019 guidance on post-marketing requirements for pregnancy-related studies, pharmaceutical and other life sciences organizations may have a renewed need for research involving the analyses of pregnant individuals, pregnancy outcomes, and/or infant outcomes. Although pregnancy exposure registries are commonly used to monitor safety of drugs and biologics for use during pregnancy, these registries may have limitations. The FDA’s guidance helps to address limitations in human safety data by including additional study types such as post-authorization safety studies (PASS) using real-world clinical and claims data. These study types can help life sciences organizations demonstrate the safety of their products and adhere to regulatory requirements.

Join experts from IBM Watson Health as they discuss research that utilizes proprietary algorithms to link mothers to their newborns and evaluate the impact of medication exposure during pregnancy on both maternal and newborn outcomes.

Learning Objectives:

  • Learn how the FDA’s guidance may impact post-market pregnancy safety study strategy.
  • Understand the considerations for using administrative claims data, electronic health record data, and registries to address post-market pregnancy safety study guidance.
  • Review methods related to best practices and important considerations in using administrative claims and electronic health record data for pregnant safety studies including identification of pregnancy outcomes and validation, estimation of gestational age and pregnancy start date, linkage of infants to their mothers and evaluation of the impact of maternal exposure or comorbidity on pregnancy and infant outcomes.

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