Event

Optimizing Pregnancy Registries

Friday, March 28, 2025
9:00 a.m.-12:00 p.m.
FDA White Oak Campus, Silver Spring Maryland
ONDPublicMTGSupport@fda.hhs.gov

Date & Time

March 27, 2025, from 9:00 AM to 4:00 PM

March 28, 2025, from 9:00 AM to 12:00 PM

Workshop Location

FDA White Oak Campus
Building 31, Conference Center, The Great Room (Room 1503)
10903 New Hampshire Ave.
Silver Spring, MD 20993

Organized By

CDER Office of New Drugs, Division of Pediatrics and Maternal Health

M-CERSI

Registration

Please click back for the registration link. 

Summary

The Food and Drug Administration is announcing the following public workshop entitled "Optimizing Pregnancy Registries." The purpose of the public workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. This public workshop is being held in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) program.

Objective

This current public workshop is part of FDA’s commitment to advance optimal approaches to efficient generation of high-quality human safety data for drug products used during pregnancy. The purpose of the workshop is to discuss current challenges and approaches to optimize and improve pregnancy registries with key interested parties.

Topics for Discussion

The objective of the meeting is to discuss the following topics with interested parties:

• Current status of pregnancy registries and challenges in gathering data regarding the safety of drug and biological products used during pregnancy. 
• Perspectives from interested parties (FDA, academia, industry, health care providers, and patients) on strategies to improve the design and conduct of pregnancy registries.
• Innovative approaches/models to facilitate the conduct of pregnancy registries, including disease based multi-product, multi-sponsor pregnancy registries.

Agenda

Please check back for an updated agenda.

Visiting the FDA Campus (If held at FDA Campus)

Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Virtual Attendance Information 

This workshop will be hybrid. The Zoom link will be provided to all registered attendees in a calendar invite the before the meeting.

Food & Drink 

Refreshments and sandwiches are available for purchase. Attendees may bring their own food and drink; however, the FDA cannot guarantee the use of a refrigerator or microwave. Restaurants near the FDA White Oak campus are available, but before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.

Accessibility

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 14 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Contact

For additional details, contact the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.

Funding Statement 

This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science & Innovation, U01FD005946 totaling $30,000 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.