4th Annual FDA/MTLI Medical Device and IVD Statistics Workshop (Event)

• Data Standards, Data Quality, CDISC
• Assuring Device Trial Data Quality for Regulatory Decision Making: Can Data Standards help
• Handling of Missing Data in Clinical Trials: Findings of a National Research Council Study
• Tipping-point Analysis in Medical Device Clinical Trials
• Minimizing Missing Data in Study Design: A Regulatory Perspective
• Good Statistical Practices
• What Constitutes a Good Statistical Analysis Plan
• What Constitutes a Good Statistical Section in a PMA or 510(k)
• Issues with trials incorporating Bayesian and/or Adaptive Designs
• Decision Rules and Associated Sample Size Planning for Regional Approval Utilizing Multi-Regional Clinical Trials
• Multiple Testing of Biomarkers in Pharmacogenomics
• Multiplicity issues in Practice: an Industry Perspective
• Non-randomized Study Design Including Propensity Score Analysis
• Statistical Points to Consider in the Precision Testing of Immunohistochemistry Assays
• Interpretation Schema Of Visual Test Results: Interpretation Of Immunohistochemistry, Current Paradigms, and Challenges
• Patient Assessment Algorithms: A Regulatory Perspective
• Statistical Issues in Combining Data from Multiple Sources to Estimate aAsolute Risk
• Strategies for Combining Biomarkers and Clinical Factors to Assess Risk of Disease Progression
• Software Validation and Some Personal Experiences with R Packages: Creation, Testing and Use
• Validation and Verification of Statistical Programming
• FDA’s Perspective on the Best Practice for Software Validation for IVD Products
• Monitoring

See Advamed website for more details