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Tuesday, June 29 • 10:00am - 11:00am
#210 SL: Assuring Access to Safe Medicines in Pregnancy and Lactation: International Regulators Perspective

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-559-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Shannon Thor, PharmD, MS


EMA Perspective: COVID-19 as a Case Study
Agnès Saint-Raymond, DrMed

Overview through January 2020
Sandra L. Kweder, MD

MHRA Perspective
Janet Nooney, PhD, FFPM

FDA Update
Lynne Yao, MD

avatar for Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy & Strategy, Europe Office, FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office, working closely with European regulatory counterparts to accomplish international public heath goals. Previous... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →

Janet Nooney

Expert Scientific Assessor, VRMM- Benefit Risk Management, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Dr Janet Nooney is an expert scientific assessor in pharmacovigilance at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dr Nooney divides her time between co-ordinating the MHRA’s strategy on improving information for use of medicines during pregnancy... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of Division International Affairs, European Medicines Agency, Netherlands
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Tuesday June 29, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session