DIA/FDA Statistics Forum

Events

  • 20 April - 22 April 2015
  • North Bethesda, MD, USA
  • Organiser: DIA and FDA
  • Event Details

Now in its ninth year, the DIA/FDA Statistic Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. This unique Forum continues the dialogue on issues including FDA guidance development and regulatory science initiatives. You will have the opportunity to 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.

Featured Topics:

Biosimilars/Analytical Similarity
Adaptive Design and Bayesian Working Group Feedback
Sentinel Initiative and Postmarketing Surveillance
Statistical Issues Related to Health Technology Assessment
Subgroup Analysis
Benefit-Risk Estimands and Sensitivity Analyses
FDA and Industry Town Hall

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