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About DIA/FDA Statistics Forum 2013

Please join us at the DIA/FDA Statistics Forum 2013 where this forum offers in-depth discussions on key topics relevant to the evaluation of therapeutic products and includes input from key thought leaders from regulatory agencies, industry, and academia. The dialogue will focus on statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis and reporting of clinical trials and assessments of safety and effectiveness in the pre- and post-market settings.

Forum Highlights

Bob RodriguezKeynote Speaker:
Monday, April 29

Robert N. Rodriguez, PhD
Past President, American Statistical Association
Senior Director, Statistical Research and Development
SAS Institute

Session Topics:

  • PDUFA V Overview
  • Statisticians as Leaders
  • FDA Upcoming Guidance Update (Multiplicity and Enriched Populations) 
  • Dichotomizing Continuous Measures for a Primary Efficacy Endpoint – Weighing the Benefits and Risks
  • Measures for Primary Efficacy Endpoint – Are we Substantially Compromising Statistical Power?
  • Pre-Competitive Collaboration
  • Meta Analysis for Safety Data
  • Companion Diagnostics
  • (Premarketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review 
  • (Premarketing) Benefit-Risk Assessments
  • Health Technology Assessment and Comparative Effectiveness Research: Their Impact on Access to Pharmaceutical Products and Their Role in Designing Product Development Strategies
  • Missing Data: When is it Important to Collect Data After Study Drug Discontinuation?
  • Missing Data:  Case Study Presentation and Panel Discussion
  • Overview and Commentary of FDA Guidances:  Multiplicity and/or Enriched Populations

Tutorial Topics:

With the success of last year’s forum we will continue to offer additional avenues for interaction and scientific discourse via a scientific poster session during the networking reception and an interactive round-table luncheon event.

Who Should Attend?

  • Statisticians
  • Clinicians 
  • Epidemiologists 
  • Pharmacometricians 
  • Drug Safety Professionals  
  • Regulatory and Medical Communication Scientists

This program will be developed by the Food and Drug Administration (FDA) and the DIA Statistics Community.

Co-sponsored by:

FDA


DIA/FDA Statistics Forum 2013




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