REGISTRATION FORM Topics What does the new electronic submission requirement mean for you? eCTD Guidances and Technical Specifications, EU resources and notices Module 1 and Submission Regulations in EU docuBridge login and intro Compilation: Module 1: Administrative Information Module 3: Quality Compilation: Module 3: Quality (continued) Module 2: Summaries; Section 2.3 Quality Overall Summary Hands‐on Compilation: selected excercises Module 4: Nonclinical Module 5: Clinical compilation: Administrative envelope (submission metadata) Publish and Validate submission Validation, Review Validation Reports Lifecycling of Applications (hands‐on compilation) eCTD Readiness what it really means –
REGISTRATION FORM Topics What does the new electronic submission requirement mean for you? eCTD Guidances and Technical Specifications, EU resources and notices Module 1 and Submission Regulations in EU docuBridge login and intro Compilation: Module 1: Administrative Information Module 3: Quality Compilation: Module 3: Quality (continued) Module 2: Summaries; Section 2.3 Quality Overall Summary Hands‐on Compilation: selected excercises Module 4: Nonclinical Module 5: Clinical compilation: Administrative envelope (submission metadata) Publish and Validate submission Validation, Review Validation Reports Lifecycling of Applications (hands‐on compilation) eCTD Readiness – what it really means