Expert Workshop: Patient and Consumer Engagement in FDA’s Sentinel Initiative

The U.S. Food and Drug Administration’s Sentinel Initiative has made important strides towards developing a valuable tool that can actively monitor the safety of medical products. Productive and broad collaboration among stakeholders from public and private institutions has been instrumental to this success. Since the Initiative’s inception, patient and consumer organizations have provided valuable perspectives and input into Sentinel.

On March 1, the Engelberg Center hosted an expert workshop, “Patients and Consumer Engagement in FDA’s Sentinel Initiative,” to explore opportunities for further engagement of these stakeholders in the Sentinel Initiative. This meeting brought together representatives from patient and consumer advocacy organizations and FDA to do the following:

• Provide patients and consumers with an overview of the Sentinel Initiative;
• Discuss opportunities for further patient and consumer engagement; and
• Discuss concrete next steps for evolving patient and consumer engagement.