Refining Patient Reported Outcomes
- November 28, 2007
Event: Interpret FDA's Draft Guidance on PRO and Proactively Prepare for Upcoming Changes
CBI's Premier Conference on Patient Reported Outcomes - Design, Validate and Integrate PRO Tools to Improve Patient Safety, Achieve Commercial Objectives and Facilitate FDA Acceptance of Outcomes Data (Arlington, VA)
Time: 1:30 - 2:15
Overview:
In February 2006, the FDA released their draft guidance on Patient Reported Outcomes. Although the document has been available for more than ayear, the complex workding used to regulate the usage of PRO can be interpreted in a variety of ways. The sections of the guidance that address electronic patient reported outcomes are particularly ambigous. However, it can be inferred that the FDA wants the industry to move in the direction of ePRO. During this session, the guidance document is interpreted and upcoming, anticipated changes are discussed.
Jean Paty, Ph.D., Co-Founder and Senior Vice President, Scientific, Quality and Regulatory Affairs, invivodata, inc. and Chief Scientific & Regulatory Advisor, PRO Consulting
