- Date:
- May 16 - 17, 2022
- Day1:
- Mon, May 16 10:00 a.m. - 03:00 p.m. ET
- Day2:
- Tue, May 17 10:00 a.m. - 02:00 p.m. ET
About this Virtual Workshop:
The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled “Pharmacokinetic Evaluation in Pregnancy” on May 16-17, 2022. The purpose of this workshop is to engage with stakeholders to assess available science and data gaps to advance the conduct of pharmacokinetic (PK) studies in pregnant women.
Most pregnant women use prescribed or over-the-counter medications during pregnancy; however, this population has historically been excluded from clinical trials. Therefore, there are important gaps in knowledge about the appropriate dosing for most medications used during pregnancy at the time of approval. In the absence of data, the approved adult dose is typically prescribed to a pregnant woman. However, because of the physiologic changes in pregnancy, under dosing or excessive dosing may occur, with potential adverse impacts on safety and efficacy. Further pharmacologic research and collection of PK data during pregnancy are needed to ensure that the appropriate dosing information is available for pregnant women. Advancing this field requires identifying key knowledge gaps, barriers to data collection, and potential innovative solutions to improve data generation and analysis.
Workshop Objectives:
- Review the general landscape of existing regulatory, scientific, and ethical considerations for drug development in pregnant women
- Describe study design considerations for trials collecting PK data in pregnant women
- Discuss key aspects of utilizing modeling and simulation to inform study design and dosing considerations for pregnant women
- Explore innovative approaches to data generation and analysis in pregnant women
Meeting Information and Registration:
This workshop is open to the public with no cost to attend and is intended for clinicians, academicians, and drug developers, but registration is required. This virtual public workshop will be available to view via webcast. Registrants will receive the link to access the live workshop several weeks prior to the meeting.
For more information, visit the MCERSI Webpage at: https://cersi.umd.edu/event/17326/fdam-cersi-workshop-pharmacokinetic-evaluation-in-pregnancy
To register, visit: https://bioeumd.wufoo.com/forms/modi0au1wjs8as/
Contact:
For questions regarding this event, please contact:
Daphne Guinn
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
OCPWorkshops@fda.hhs.gov
