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Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective
Session Chair(s)
Shannon Thor, PharmD, MS
Deputy Director, Office of Global Policy & Strategy, Europe Office
FDA, United States
There is increasing interest in both Europe and the United States in establishing more formal methods and robust strategies to improve knowledge of the safety and efficacy of drugs and biological products when used during pregnancy and lactation. This session will recap a meeting of MHRA, EMA, and FDA held in January 2020 to discuss possibilities for addressing this challenge.
Learning Objective : Explain current regulatory frameworks and authorities for Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), and US Food and Drug Administration (FDA) surrounding pregnancy and lactation; Discuss potential future regulatory efforts that could enhance the safe use of medicines in pregnancy and lactation.
Speaker(s)
EMA Perspective: COVID-19 as a Case Study
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
Overview through January 2020
Sandra Kweder, MD
Greenleaf Health/Elilquent, United States
Principal, Drug and Biological Products
MHRA Perspective
Janet Nooney, PhD, FFPM
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Scientific Assessor, VRMM- Benefit Risk Management
FDA Update
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
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