November 17, 2023 (Noon-4 p.m.)
Sponsor/Co-Sponsor(s)
NICHD
Location
Virtual
Purpose
In 2023, NICHD formed the PRGLAC Implementation Working Group of Council to monitor and report on the implementation of recommendations for improving knowledge and research on safe and effective therapeutics for pregnant and lactating people. The recommendations came from the congressionally mandated, NICHD-led PRGLAC, established as part of the 21st Century Cures Act.
The current PRGLAC Implementation Working Group of Council will host this series of meetings on implementation activities, with the anticipated goal of presenting updates and findings to NACHHD Council in June 2024.
Individuals who need any other reasonable accommodations to participate in this activity should contact Emma Carpenter at emma.carpenter@nih.gov or 202-205-2279 at least 5 days in advance.
Agenda and Presentations
- Meeting agenda (PDF 176 KB)
- Session I presentation: Overview of Original PRGLAC Task Force and Current Group Goals (PDF 388 KB)
- Session II presentations
- Update on NICHD’s Support for Leveraging Data Resources (PDF 2 MB)
Katie M. Vance, Ph.D., Associate Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NICHD - MaternalHealthLink (PDF 526 KB)
Juanita Chinn, Ph.D., Program Director, Population Dynamics Branch, NICHD
- Update on NICHD’s Support for Leveraging Data Resources (PDF 2 MB)
- Session III presentations
- U.S. Core Data for Interoperability (USCDI)+ for Maternal Health (PDF 803 KB)
Stephanie Garcia, M.P.H., Branch Chief, Office of Technology, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services - PRGLAC Task Force Experience from FDA CDER’s Sentinel System: Using Electronic Health Record Data to Link Mother and Infant Records (PDF 3 MB)
Patricia Bright, Ph.D., Regulatory Science Staff, Office of Surveillance & Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) - FDA Updates Relevant to PRGLAC Recommendation 13: Optimize Registries for Pregnancy and Lactation (PDF 807 KB)
Leyla Sahin, M.D., Deputy Director for Safety; Division of Pediatrics and Maternal Health; Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine; Office of New Drugs, CDER, FDA
- U.S. Core Data for Interoperability (USCDI)+ for Maternal Health (PDF 803 KB)
More Information
Contact
Emma Carpenter, Office of Legislation, Public Policy, and Ethics, Office of the Director, NICHD
Email: emma.carpenter@nih.gov
Phone: 202-205-2279
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