Patient-Reported Outcomes (PROs)- Overview of the Final FDA Guidance Document

There's a complimentary webinar coming up on this topic: Patient-Reported Outcomes (PROs)- Overview of the Final FDA Guidance Document

Tuesday, February 23, 2010

11:00 AM- 12:00 PM ET

Webinar Overview:

Attend this webinar to hear an overview of the recently released Final FDA Guidance document on Patient-Reported Outcomes (PROs) with a specific focus on electronic PRO data collection.

This webinar provides practical and logistical direction to Sponsors related to PRO data collection.

Issues to be Reviewed Include:

• Establishing and documenting content validity
• Determining optimal PRO format and user interface
• Application of 21 CFR Part 11 within electronic PRO data collection

Presenters:

Karin Coyne, PhD, MPH,
Senior Research Leader,
United BioSource Corporation Center for Health Outcomes Research

Sonya L. Eremenco, MA,
ePRO Program Manager,
United BioSource Corporation Center for Health Outcomes Research

Shiela McLaughlin,
Vice President, Quality Assurance
Arrowhead Electronic Healthcare

Sponsored by United BioSource Corporation and Arrowhead Electronic Healthcare

The Center for Business Intelligence has been reviewed and approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

Click here to register.