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Session 4, Track C: Creating a Safer Framework for Medicines Use in Pregnant and Breastfeeding People
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director, GSK, Canada
Vanessa Zapata
Associate Director, Regional Pharmacovigilance Officer, Merck Canada Inc., Canada
Globally, >800 women and >12,000 newborns die daily due to complications of pregnancy. Drugs are required for pregnant women, but only two were developed for this purpose. In this session, the regulatory environment for drug safety in pregnancy, and proposed solutions for the use of medicines in pregnancy will be discussed.
Learning Objective : - Recognize current global regulations and guidelines governing use of medicines in pregnancy and breastfeeding based on the Landscape Assessment of global guidelines and regulations
- Discuss tools (“Points-to -Consider”) for the use of medicines in pregnancy and when breastfeeding, particularly during clinical development
- Identify different initiatives ongoing for a safer use of medicines during pregnancy and breastfeeding
Speaker(s)
Keele Wurst, PhD, RPh
Senior Director and Head, Safety Science Epidemiology, GSK, United States
TransCelerate: Points to Consider for Pregnancy throughout the Product Lifecycle Based on the Regulatory Guidelines and Regulations Across the Globe
Anick Berard, PhD, FISPE
Full Professor and Senior Researcher, University of Montreal, Canada
Canadian Mother-Child Initiative on Drug Safety in Pregnancy
Marcy Powell, MD
Medical Director, Safety Evaluation and Risk Management, GSK, United States
Speaker
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