Monday Morning Sessions
Two great sessions will occur on Monday at 9 am. The ILSI HESI Symposium entitled Communication of Risk for Medication Use in Pregnancy and Lactation is jointly held with OTIS. The anticipated Pregnancy Labeling and Lactation Labeling Rule will change the structure of the current Pregnancy and Nursing Mothers' sections of the US label. The proposed labeling changes will reformat and present the clinically relevant available human and animal data. This symposium will examine the sources and types of data needed to write informed labeling to convey potential risks for pregnant, breastfeeding, and reproductively active women and more broadly, how to best communicate risk when the data indicate effects of the drugs (or the underlying disease) on fertility, fetal development and lactation. The Molecular and Cellular Mechanisms of Abnormal Development platform session will feature nine presentations.