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May 8, 2013

FoREMS & More: Reviewing a "Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making"

May 8, 2013

12:00 pm - 1:00 pm ET

FoREMS & More: Reviewing a "Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making"

A key topic in the PDUFA V performance goals was an enhanced structured approach to benefit-risk assessment. In February, FDA issued a Draft Implementation Plan.  

This webinar will:

  • Review the Draft Implementation Plan
  • Identify key insights for risk management professionals
  • Comment on how this fits in the overall evolution of benefit-risk management trends

Speaker:
Jeff Fetterman – President, ParagonRx

To view the presentation slides, click here.

To register for this webinar, click here.

Click here to review the document, "Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making".


To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email info@paragonrx.com