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Wednesday, June 21 • 2:00pm - 3:15pm
#351: Pregnancy and Lactation Labeling Rule: Unique Challenges to Meet Requirements

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-551-L04-P; CME 1.25; IACET 1.25; RN 1.25

In December 2014, the FDA published “The Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling,” referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR). Drug manufacturers are required to provide specific details pertaining to drug use in pregnancy, lactation, and reproductive risks associated with the drug's use. Companies are encouraged to generate and evaluate data for both pregnancy and lactation, which raise very interesting questions for drug manufacturers and the patient populations that they treat. This session will examine many of these questions. What challenges do manufacturers face when generating, evaluating, and submitting data on the safety of their products for use during pregnancy or lactation? Are current methods of data generation or capture, such as registries, effective, and are there alternatives? In the case of lactation, how do you recruit patients for lactation studies?

Learning Objectives

Discuss the challenges of data generation and evaluation to comply with the requirements of the Pregnancy and Lactation Labeling Rule (PLLR), present sponsor experiences with updates to labeling in accordance with PLLR; Review an innovative approach for obtaining robust data from a lactation study

Chair

Leslie Driver, PharmD

Speaker

P-L-L-R: Not as eXtraordinarily Simple as A-B-C-D
Leslie Driver, PharmD

Pregnancy and Breastfeeding, Drug Development, and the Public Health
Nina Liang, PhD

Innovative Approaches for Conducting a Lactation Study
Nicole R Hurst


Moderators
avatar for Leslie Driver

Leslie Driver

Director, Regulatory Affairs, GlaxoSmithKline
Dr. Driver is a Director with the GSK US Regulatory Affairs Classic and Established Products team where she serves as the Regulatory representative for several marketed products and has led many PLLR labeling updates and awareness sessions. Prior to joining Regulatory, Dr. Driver... Read More →

Speakers
avatar for Nicole Hurst

Nicole Hurst

Director, Project Management, PPD
Nicole Hurst, MSW, BSW, is a Director of Project Management at PPD, Inc. Since joining PPD in 2006, Nicole has primarily managed and overseen postmarketing studies, with a focus in pregnancy and lactation. Nicole is a published author and an experienced presenter at scientific conferences... Read More →
NL

Nina Liang

Associate Director, Regulatory Affairs, Novo Nordisk Inc.
Nina Liang is an Associate Director Regulatory Affairs at Novo Nordisk Inc with 14 years experience in Regulatory Affairs. She is the US Regulatory Project lead for a variety of projects and products at different developmental stages from research through commercialization. Nina recently... Read More →

Wednesday June 21, 2017 2:00pm - 3:15pm CDT
S501abc McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  07: SpecialPops, Session