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Ottawa Conference and Event Centre

Nov 07, 2023 7:30 AM - Nov 08, 2023 4:10 PM

200 Coventry Road, Ottawa, ON K1K 4S3, Canada

Canada Annual Meeting

The Canada Annual Meeting offers Three Tracks, Regulatory, Clinical, Pharmacovigilance!

Session 4, Track C: Creating a Safer Framework for Medicines Use in Pregnant and Breastfeeding People

Session Chair(s)

Marcia  Bailey, BSN, MHS, RN

Marcia Bailey, BSN, MHS, RN

Safety Evaluation and Risk Management Scientific Director

GSK, Canada

Vanessa  Zapata

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

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

Anick  Berard, PhD, FISPE

Canadian Mother-Child Initiative on Drug Safety in Pregnancy

Anick Berard, PhD, FISPE

University of Montreal, Canada

Full Professor and Senior Researcher

Marcy  Powell, MD

Speaker

Marcy Powell, MD

GSK, United States

Medical Director, Safety Evaluation and Risk Management

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