Optimizing Pregnancy Registries Public Workshop

May 7 & 8 at the FDA White Oak Campus, Silver Spring Maryland

About this event: 

The purpose of the 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.

FDA Website 

Objective:

This 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: 

• 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 but not limited to disease based multi-product, multi-sponsor pregnancy registries and coordinated registry networks.