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The FDA’s draft guidance for Risk Evaluation and Mitigation Strategies (REMS) specifies that applicants may undertake voluntary risk management measures that are performed outside of a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:
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