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eSUBmanager/EURSnext Basic Training Course


Content
  • What's New in eSUBmanager / EURSnext?
  • What's New in eSUBmanager/EURSnext version 23.10?
  • What's New in eSUBmanager/EURSnext version 23.06?
  • What's New in eSUBmanager/EURSnext version 6.2?
  • What’s New in eSUBmanager/EURSnext version 6.1?
  • Introduction: Start eSUBmanager, get familiar with the User Interface
  • "eSUBmanager" in the Life Science Industry
  • Start eSUBmanager
  • The Start Page
  • The Projects Grid - Applications
  • The Projects Grid - Submissions
  • Open Submissions and Documents
  • Flexible Window Handling
  • Multi-Lingual User Interface
  • User Menu, Online Help
  • Test: eSUBmanager first steps
  • eSUBmanager Story 1 - THE CONTENT OF THE INITIAL SUBMISSION
  • The Content of the Initial Submission: EU M1 Structure
  • Examples for other Regions and Formats
  • Specific Sections and Node Extensions
  • Document Viewer
  • Test: Content of the initial submission, Document Viewer
  • eSUBmanager Story 2: Reviewing the initial Submission
  • Search for Information in Dossiers, Documents and Regulatory Activities
  • Test: Search for Information
  • The Reviewing Tools; Annotations and Highlights
  • Test: The Reviewing Tools
  • eSUBmanager Story 3: Reviewing follow-up sequences
  • Navigation in the Hierarchy, Working with Favorites
  • Test: Navigating in the the Hierarchy Explorer
  • Dossier Lifecycle
  • Document Lifecycle
  • Lifecycle Views and Filters
  • Test: Document Lifecycle
  • Comparing Document Versions in the Lifecycle
  • Comparing any two Documents
  • Document Comparison
  • eCTD Dossier Lifecycle: some examples of follow-up sequences in EU dossiers
  • NEW: Submission Staging - maintain multiple sequences in the same dossier!
  • The "Authorized View Mode"
  • eSUBmanager Story 4: Do you need assessment assistance?
  • Several ways to get information out of eSUBmanager/EURSnext
  • Links in the Grid
  • Tools to extract information from eSUBmanager/EURSnext
  • eSUBmanager Story 5: your electronic Assessment Report
  • Your electronic Assessment Report
  • The electronic Assessment Report
  • eSUBmanager Story 6: Submission Content Planning & Tracking with eCTDmanager
  • Submission Content Planning and Tracking
  • NEW - Supported Submission Formats
  • Supported Submission Formats
  • China CDE eCTD Submissions
  • Eurasian Economic Union (EAEU) Applications
  • Japanese eCTD Submissions
  • World Health Organization (WHO) eCTD Submissions
  • eCTD 4.0 Applications
  • NEW - Full-text Search for Content in Project, Storages, Dossiers, Submissions
  • Introduction to the new Full-text Search
  • Perform a Full-Text Search
  • Handling Large Search Results; Exact vs. Partial Matches
  • NEW - Logical Search Based on Metadata
  • Logical Search Based on Metadata - Introduction
  • Open the Search Screen, Creating and Executing a Query
  • Logical Search Templates: Executing a Global Query Template
  • NEW: Custom Attributes
  • Custom Attributes - Introduction
  • Prioritization of Custom Attribute Changes
  • Visualization of Custom Attributes
  • Maintenance of Local Custom Attributes, Pre-defined Custom Attributes
  • Adding New Custom Attributes to a selected Element
  • Editing Custom Attributes for a selected Element
  • Deleting Custom Attributes from a selected Element
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete the units "Start eSUBmanager, Test: eSUBmanager first steps, The Content of the Initial Submission: EU M1 Structure, Document Viewer, Test: Content of the initial submission, Document Viewer, Search for Information in Dossiers, Documents and Regulatory Activities, Test: Search for Information, The Reviewing Tools; Annotations and Highlights, Test: The Reviewing Tools, Navigation in the Hierarchy, Working with Favorites, Test: Navigating in the the Hierarchy Explorer, Document Lifecycle, Test: Document Lifecycle, Comparing Document Versions in the Lifecycle, Document Comparison, Several ways to get information out of eSUBmanager/EURSnext, Tools to extract information from eSUBmanager/EURSnext, Your electronic Assessment Report, The electronic Assessment Report"
  • Leads to a certificate with a duration: 1 year