*Short Courses require an additional registration fee. You do not need to be registered for the forum to attend*

Incorporating patients’ and caregivers’ voices into medical product development and regulatory decision making requires robust methods. FDA is developing a series of four methodological guidances that together are intended to support efforts to identify what matters to patients, how best to measure what matters, and how to evaluate the effects of interventions designed to improve how patients feel or function. Once all four of the PFDD guidances are final, they will replace the 2009 PRO guidance. This session will step through key methodological considerations found in the publicly available guidance documents in the FDA’s Patient-Focused Drug Development (PFDD) Guidance series.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!