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Tuesday, June 18 • 4:30pm - 5:30pm
#278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-610-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Martine Dehlinger-Kremer, PhD

Speaker

Assessment of Drugs Used During Pregnancy: Current Status
Martine Dehlinger-Kremer, PhD

Safety of Drugs Used During Pregnancy: Regulatory Considerations and Updates
Lynne Yao, MD

Post-Marketing Approval Safety Studies: The Role of Pregnancy Registries
Christina Chambers, PhD, MPH

Evaluation of Drug Use During Pregnancy: Post-Marketing Surveillance and Beyond - Time for a Paradigm Shift
Laura Shaughnessy


Speakers
avatar for Martine Dehlinger-Kremer

Martine Dehlinger-Kremer

Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON Plc, Germany
Dr. Dehlinger-Kremer’s has over 30 years experience in research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior joining ICON, she served in executive leadership roles at global CROs, gained experience in global... Read More →
avatar for Christina Chambers

Christina Chambers

Distinguished Professor, Pediatrics, University of California San Diego, United States
Dr. Christina Chambers is a Professor in the Department of Pediatrics, School of Medicine at UC San Diego. She is Chief of the Division of Environmental Science and Health, and Co-Director of the Center for Better Beginnings. She is the principal investigator of MotherToBaby Pregnancy... Read More →
LS

Laura Shaughnessy

Clinical Program Director, UCB Biosciences, United States
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 18, 2024 4:30pm - 5:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session