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Addressing Concerns and Considerations Surrounding Inclusion of Pregnant and Lactating Populations in Research
Pregnant and lactating women have historically been excluded from clinical trials. Federal policies from the 1970s that excluded “women of childbearing age” from research led research to use male participants, limiting our knowledge base. Although a 1994 report from the Institute of Medicine recommended that pregnant women be presumed to be eligible to participate in clinical studies and that lactating women not be excluded from clinical studies, concerns remain about including pregnant and lactating populations in research.

During this congressional briefing and national webinar, panelists will review ethical considerations surrounding inclusion of pregnant and lactating women in research, how to ensure the appropriate inclusion of these populations, and the current state of this type of inclusion in research, both within the federal government and the corporate sector.

Panelists:
- Drew Hatter, Federal Affairs Strategist, American College of Obstetricians and Gynecologists (Moderator)
- Christina Bucci-Rechtweg, MD, Head, Pediatric & Maternal Health Policy, Global Drug Development Regulatory Affairs, Novartis Pharmaceutical Corporation
- Aaron Pawlyk, PhD, Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, National Institute of Child Health and Human Development
- Leyla Sahin, MD, Deputy Director for Safety, Dvision of Pediatrics and Maternal Health, U.S. Food and Drug Administration
- Catherine Spong, MD, Professor and Chair, Department of Obstetrics and Gynecology; Chief, Division of Maternal Fetal Medicine; Paul C. MacDonald Distinguished Chair in Obstetrics and Gynecology, University of Texas Southwestern Medical Center

Dec 6, 2022 02:00 PM in Eastern Time (US and Canada)

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