2021 PRO Consortium Workshop - FDA Update

The C-Path 12th Annual Patient-Reported Outcome Consortium Workshop was held in virtual format April 14-15, 2021.

Overview: Provides an update on FDA’s Clinical Outcome Assessment (COA) Qualification Program and other initiatives

Moderator: Michelle Campbell, PhD – Senior Clinical Analyst for Stakeholder Engagement and Clinical Outcomes, Office of Neuroscience (ON), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Presenters: Robyn Bent, RN, MS – Director, Patient Focused Drug Development Program, CDER, FDA
Laura Lee Johnson, PhD – Director, Division of Biometrics III, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Elektra Papadopoulos, MD, MPH – Acting Deputy Director, Division of Clinical Outcome Assessment, Office of Drug Evaluation Sciences (ODES), OND, CDER, FDA
David S. Reasner, PhD – Division Director, Division of Clinical Outcome Assessment, ODES, OND, CDER, FDA

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