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Part 2: Overcoming the Challenges of Conducting Postmarketing Studies in Pregnant and Lactating Women

Presenters

Leyla  Sahin, MD

Leyla Sahin, MD

Deputy Director for Safety, DPMH, OND, CDER, FDA, United States

Dr. Sahin is an ob/gyn who is the Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs in CDER. She has led various maternal health related scientific and regulatory/policy initiatives. She was a working group member on the HHS Task Force for Research Specific to Pregnant Women and Lactating Women (PRGLAC). The focus of her work involves providing pregnancy and lactation scientific and regulatory expertise to the review divisions in the Office of New Drugs, through all phases of drug development. Her principal area of interest is promoting the public health of pregnant and breastfeeding individuals through improved data collection.

Melissa S. Tassinari, PhD

Melissa S. Tassinari, PhD

Former Senior Clinical Advisor, DPMH, OND, CDER, FDA , Consultant , United States

Melissa Tassinari is a Senior Clinical Advisor with the Division of Pediatric and Maternal Health (DPMH), in the Office of New Drugs at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)

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