Wednesday FoREMS: Cracking the Code on REMS Assessments
Wednesday, January 13th, 2010
In many of the discussions we’ve had about REMS design and implementation, the most frequent concern we encounter is related to REMS assessment. A look at the math reveals why this is so. Over 63 REMS have been approved since FDAAA statutes for REMS became effective in March 2008. Of those, more than 90% are comprised of Medication Guides and/or Communication Plans, plus an assessment. Most clients find the process of developing and distributing Medication Guides and Communications Plans to be familiar ground. But the prospect of creating an instrument that assesses the effectiveness of those communications is far more concerning. Frequent questions include:
- What is the appropriate sample size?
- How are stakeholders recruited?
- What is the appropriate format of the questionnaire?
- What does FDA expect to be included in the protocol?
- How is the instrument fielded?
- Are assessment thresholds necessary? If so, how should they be established?
ParagonRx continues its series of monthly REMS discussions, Wednesday FoREMS, by offering this webinar which addresses many of the frequently asked questions that remain unaddressed by FDA guidance.
Webinar Slide Set
