Wednesday FoREMS: Voluntary Risk Management Measures: Opportunity or Overkill?

Wednesday April 13, 2011

Voluntary Risk Management Measures:  Opportunity or Overkill?

The FDA’s draft guidance for Risk Evaluation and Mitigation Strategies (REMS) specifies that applicants may undertake voluntary risk management measures that are performed outside of a REMS.  Some risk management professionals have successfully used such measures to achieve benefit-risk management objectives, while others wonder if it could be overkill that diverts resources and attention.  

This webinar describes four specific roles for voluntary risk management measures, how such measures can be effectively designed, and case studies of successful use.  

Presenter: Jeff Fetterman

 

Webinar Slide Set:

Click to view:
Welcome
Agenda
Background
Voluntary Risk Management Measures
Applications of Voluntary RM Measures
Augmenting Risk Management in REMS
Preparing Contingencies
Communicating Risks & Benefits
Managing Variations in Care Delivery
Voluntary RM ≠ Sales Reduction (if done correctly)
Developing Voluntary RM Measures
Evaluating Care Process to Develop Voluntary RM Measures
Promising Tools and Methods
Getting Started
case Studies
Case Study
Introduction
Background
Background
Background
Methods
Methods (cont'd)
Methods (cont'd)
Methods (cont'd)
Methods (cont'd)
Methods (cont'd)
Methods (cont'd)
Results of EXALGO RxFMEA®
Methods
Results (cont’d)
Results (cont’d)
Results (cont’d)
Results (cont’d)
Results (cont’d)
Results (cont’d)
Conclusion
References
Improving Outcomes with Voluntary RM:
Thank You

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Session Replay:



 

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