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Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective
Session Chair(s)
Shannon Thor, PHARMD, MS
FDA Liaison to the European Medicines Agency, 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)
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands
EMA Perspective: COVID-19 as a Case Study
Sandra Kweder, MD
Principal, Drug and Biological Products , Eliquent Life Sciences, United States
Overview through January 2020
Janet Nooney, PHD, FFPM
Expert Scientific Assessor, VRMM- Benefit Risk Management, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
MHRA Perspective
Lynne Yao, MD
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
FDA Update
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