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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)
TransCelerate: Points to Consider for Pregnancy throughout the Product Lifecycle Based on the Regulatory Guidelines and Regulations Across the Globe
Keele Wurst, PhD, RPh
GSK, United States
Senior Director and Head, Safety Science Epidemiology
Canadian Mother-Child Initiative on Drug Safety in Pregnancy
Anick Berard, PhD, FISPE
University of Montreal, Canada
Full Professor and Senior Researcher
Speaker
Marcy Powell, MD
GSK, United States
Medical Director, Safety Evaluation and Risk Management