Optimizing the Use of Postapproval Pregnancy Safety Studies

Start Date
September 18, 2023
10:00 am
End Date
September 19, 2023
2:30 pm
Hybrid

Event sponsored by:

Duke-Margolis Center for Health Policy
CTSI CREDO

Contact:

Margolis Events

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The background of the graphic is a photo of a doctor, who holds a stethoscope to the abdomen of a pregnant woman in a brightly lit office. The photo is cut off on the left by intersecting blue circles that provide a background for the text. The text reads: Optimizing the Use of Postapproval Pregnancy Safety Studies, a Hybrid Public Workshop. September 18, 10am - 4pm and September 19, 10am - 2:30pm. National Press Club, Washington DC, or virtual via Zoom.

The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. FDA, is convening a two-day Public Workshop that will discuss designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). During this event, participants will hear FDA's considerations for constructing a framework describing how data from different types of postapproval pregnancy safety studies might optimally be used; stakeholders' perspectives on opportunities to optimize postapproval pregnancy safety study types and designs; design considerations and potential approaches to bridge knowledge gaps in developing the framework, including understanding how the Sentinel Initiative (i.e., Sentinel System and Biologics Effectiveness and Safety (BEST)) may address these gaps; and stakeholders' perspectives on considerations for FDA's proposed framework. This event is open to all.