Analytical to Clinical: Ensuring Analytical Method Validation Supports Clinical Determination

Time: 12:20 pm
day: Day One


  • How to generate value added data that ensures clinical determinations and endpoint assessments are based on the analysis from a robust analytical method validation
  • Define what method validation really entails and the attributes that are critical to understand
  • Review the controls that are fundamental for clinical determination and the components that support validation methods
  • Reflect on how to apply the Quality By Design principles in practice and provide a roadmap to pathway success