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Our Doors are Open! Pathways and Programs for Patient Stakeholders to Engage with FDA
Session Chair(s)
Samir Shaikh, MBA
Deputy Director, Patient Affairs Staff, Office of the Commissioner
FDA, United States
This session will explore and discuss agency-wide patient engagement programs and initiatives that provide patient stakeholders (patients, caregivers and advocates) opportunities to engage with FDA and participate in regulatory discussions that inform medical product development and review.
Learning Objective : Describe how FDA has established organizational components to ensure patients are a priority; Describe avenues for patient stakeholders to engage with the agency; Explain key initiatives where patient stakeholders can share their experiences to help inform medical product development; Discuss the value of patient stakeholder participation.
Speaker(s)
FDA Perspective
Patroula Smpokou, MD
FDA, United States
Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER
Patient Perspective
Debbie Drell
National Organization for Rare Disorders (NORD), United States
Director of Membership
Patient Perspective
Sabina A. Kineen
Patient Advocate, United States
Fabry Disease
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