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Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation

Pregnant woman craddling her belly

Join the FDA Office of Women’s Health and the Johns Hopkins Center of Excellence in Regulatory Science and Innovation for a virtual public workshop titled "Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation", on Monday, May 9, 2022 from 10:00 AM – 2:30 PM ET.

Register and get additional information about this event on the JH-CERSI webpage.

Many chronic and/or pregnancy-related health conditions require the use of medication during pregnancy and lactation. However, few clinical trials enroll pregnant or lactating participants, thus, there is a lack of data on medication safety and efficacy in this population. Through a 3-session virtual workshop, we will highlight the potential role of real-world data to help address these gaps in our knowledge, the opportunities and challenges of collecting real-world data, and current regulatory perspectives on the collection and potential use of real-world data.

 

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