Slides for the June 7, 2012 Risk Evaluation and Mitigation Strategy (REMS) Assessments Public Workshop

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Morning

   FDA  

• Opening Remarks: Claudia Manzo, Pharm.D. (PDF - 43KB)

• Introduction to REMS and REMS Assessments: Mary Willy, Ph.D. (PDF - 57KB)

• Panel 1 Introduction and Charge: Robert Shibuya, M.D. (PDF - 180KB)
   

   Industry 

• Industry Experience in Using Surveys to Assess REMS’ Impact on Knowledge, Attitudes & Behavior (PDF - 164KB)
  William C. Holmes, M.D., M.S.C.E.
  Meredith Smith, Ph.D., M.P.A
   

   Open Public Speakers Session

• FDA has requested that the Open Public Speakers post their slides to the docket.
  http://www.regulations.gov
  Docket No. FDA-2012-N-0408

 

Afternoon

   FDA  

• Panel 2 Introduction and Charge: Robert Shibuya, M.D. (PDF - 90KB)
  

 
  Open Public Speakers Session

• FDA has requested that the Open Public Speakers post their slides to the docket.
  http://www.regulations.gov
  Docket No. FDA-2012-N-0408

   FDA

• Back up Slide 5: Rima Izem, Ph.D. (PDF - 190KB)