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DIA 2021 Global Annual Meeting


Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective

Session Chair(s)

Shannon  Thor, PharmD, MS

Shannon Thor, PharmD, MS

  • International Policy Analyst, 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)

Agnès  Saint-Raymond, DrMed

EMA Perspective: COVID-19 as a Case Study

Agnès Saint-Raymond, DrMed

  • Head of Division International Affairs
  • European Medicines Agency, Netherlands
Sandra L. Kweder, MD

Overview through January 2020

Sandra L. Kweder, MD

  • Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA
  • FDA, United States
Janet  Nooney, PhD, FFPM

MHRA Perspective

Janet Nooney, PhD, FFPM

  • Expert Scientific Assessor, VRMM- Benefit Risk Management
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Lynne  Yao, MD

FDA Update

Lynne Yao, MD

  • Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
  • FDA, United States