Wednesday FoREMS: Beginning with the End in Mind

Wednesday, February 10th, 2010

Beginning with the End in Mind: Managing the Effectiveness of REMS Implementation

In the midst of the anxiety and uncertainty of developing and negotiating a REMS for FDA approval, members of REMS teams at pharmaceutical companies can sometimes focus on REMS approval as an endpoint.  In reality, it is a beginning of:

  • Developing an implementation plan
  • Identifying and selecting internal and external resources to implement the REMS
  • Coordinating the activities of internal and external resources to execute the implementation plan
  • Measuring distribution metrics to determine operational compliance
  • Tracking all metrics in an organized (and perhaps automated) way to know the status of REMS compliance at any time

In this session of the Wednesday FoREMS series , Jeff Fetterman discusses REMS Implementation and best practices to achieve REMS effectiveness.

 

Webinar Slide Set

click to view:
Beginning with the End in Mind: Managing the Effectiveness of REMS Implementation
Ad Hoc REMS Activities
Proactive REMS Planning Process...
Beginning with the End in Mind: Where Do We Want to End?
REMS Implementation Management Strategy
Post-Approval REMS Challenges and Needs
Supplement REMS with non-REMS activities
Engineer Positive Customer Experience...
REMS Program Management Process
REMS Implementation Planning
Implementation Plan Topics
Implementation Plan Content
Implementation Plan Content
Post-Approval REMS Challenges and Needs
Early, Frequent, Comprehensive Measurement of Program Performance
REMS Effectiveness Management
REMS Effectiveness Management: Example Metrics
The REMSView™ Dashboard
The REMSView™ Dashboard
Continuous Improvement of REMS Implementation
Active Management of REMS Implementation Summary
REMS Implementation Management Strategy Summary and Benefits

 

Session Replay



 

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