Webinar Replay: Practical Implications of the FDA Draft PRO Guidance

Overview:
A Web Seminar discussing life after the FDA’s Draft PRO Guidance. Covered topics included: Meaning of “Conceptual Framework” as defined by the FDA; Best practices in defining a solid endpoint model; Necessary steps to determine the validity of a PRO measure; and, Practical steps to migrate from paper to electronic patient reported outcomes (PROs).

Presented by
Jean Paty, Ph.D.
Chief Scientist and Regulatory Advisor,
PRO Consulting

Brian Tiplady, Ph.D.
Sernior Scientific Consultant ,
PRO Consulting

After the presentation, PRO Consulting’s Dr. Jean Paty, Chief Scientistand Regulatory Advisor and Dr. Chad Gwaltney, Scientific Consultant and Assistant Professor of Research at Brown University participated in a live discussion period.

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