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Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy
Session Chair(s)
Martine Dehlinger-Kremer, PhD
VP Scientific Affairs, Pediatric SME, ICON Plc & President, EUCROF
Icon Plc, Germany
Pregnant individuals are underrepresented in research. This session provides an overview of how the evolving regulatory framework, pharmaco-epidemiology, and clinical trials can advance evidence generation and contribute to pregnancy labeling.
Learning Objective : Discuss important global advances in the collection of data in drugs and biological products used during pregnancy; Identify the evolving regulatory framework, and the value of premarket and postmarketing safety data that can lead to improved labeling information for drugs and biological products used in pregnancy; Describe stakeholder efforts to include pregnant individuals in clinical trials.
Speaker(s)
Assessment of Drugs Used During Pregnancy: Current Status
Martine Dehlinger-Kremer, PhD
Icon Plc, Germany
VP Scientific Affairs, Pediatric SME, ICON Plc & President, EUCROF
Safety of Drugs Used During Pregnancy: Regulatory Considerations and Updates
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
Post-Marketing Approval Safety Studies: The Role of Pregnancy Registries
Christina Chambers, PhD, MPH
University of California San Diego, United States
Distinguished Professor, Pediatrics
Evaluation of Drug Use During Pregnancy: Post-Marketing Surveillance and Beyond - Time for a Paradigm Shift
Laura Shaughnessy, PhD
UCB Biosciences, United States
Clinical Program Director
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