Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group of Council

January 19, 2024 (Noon-4 p.m.)

Sponsor/Co-Sponsor(s)

NICHD

Location

Virtual; NIH VideoCast

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 at least 5 days in advance.

Presentations

• Opening remarks presentation (PDF 966 KB)
• Session I presentations
  • Leveraging Clinical Trial Networks for Advancing Therapeutics in Pregnancy (PDF 2 MB)
    Nahida Chakhtoura, M.D., Ms.G.H., Chief, Pregnancy and Perinatology Branch, NICHD
  • Catalyzing Innovation in Maternal Therapeutics: Novel Networks and Drugs (PDF 4 MB)
    Aaron C. Pawlyk, Ph.D., Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), NICHD
  • Progress on Prioritization of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons (PDF 329 KB)
    Camille Fabiyi, Ph.D., M.P.H., Program Officer, OPPTB, NICHD
• Session II presentation
  • U.S. Food and Drug Administration (FDA) Update: Recommendation 10 (PDF 586 KB)
    Lynne Yao, M.D., Director, Division of Pediatrics and Maternal Health; Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research; FDA

Contact

Emma Carpenter, Office of Legislation, Public Policy, and Ethics, Office of the Director, NICHD
Email: emma.carpenter@nih.gov