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Modeling approaches in pregnancy and lactation for drug development: operational, ethical and regulatory perspectives

Regulatory Experiences and Considerations for Model-Informed Approaches to Drug Development in Pregnancy and Lactation

Monday, November 11, 2024

11:45 AM – 11:55 AM MST

Location: Sonoran Sky Ballroom 5 - 8

Speaker(s)

Elimika Pfuma Fletcher, PharmD, PhD (she/her/hers)

Clinical Pharmacology Policy Lead
U.S. Food and Drug Administration, United States

Disclosure(s): No financial relationships to disclose

Disclosure(s):

Elimika Pfuma Fletcher, PharmD, PhD: No financial relationships to disclose

This presentation will provide a regulatory perspective on MIDD approaches for drug development in pregnant and breastfeeding mothers and their infants. Elimika will also present on application of PBPK modeling to inform a comprehensive risk assessment of infant drug exposures from maternal therapy during breastfeeding.