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eSUBmanager/EURSnext Basic Training Course


Content
  • What's New in eSUBmanager / EURSnext?
  • What's New in eSUBmanager/EURSnext version 24.02
  • Introduction: Start eSUBmanager, get familiar with the User Interface
  • "eSUBmanager" in the Life Science Industry
  • eSUBmanager Log-In (0:30)
  • Multi-Lingual User Interface (0:30)
  • Flexible Window Handling (0:45)
  • User Menu, Online Help (2:35)
  • The Start Page and Dashboards
  • The Start Page (0:30)
  • Individually arrange the Start Page and Dashboard Widgets (1:10)
  • Favourite Submissions (0:45)
  • Recently Used Submissions and recently Viewed Documents (0:40)
  • Recently Used Applications Explorer Grid Filter Presets (0:45)
  • Recently Imported or Updated Dossiers (0:30)
  • Introduction to the Dashboard (0:25)
  • Distribution of Registrations per Country (1:20)
  • Available Applications per Regions and Formats (0:55)
  • Working with Dashboard Charts (0:30)
  • PRojects, Applications and Submissions
  • The Projects Grid (0:25)
  • Applications / Dossiers (3:35)
  • Submissions (0:25)
  • Open a Submission / Sequence (0:45)
  • Test: eSUBmanager first steps
  • Story 1 - THE CONTENT OF THE INITIAL SUBMISSION
  • The Content of the Initial Submission (0:45)
  • Specific Sections and Node Extensions (1:15)
  • Open and close a Document, Document Attributes and Lifecycle (0:55)
  • Basic Features of the Document Viewer (3:10)
  • Test: Content of the initial submission, Document Viewer
  • Story 2: Reviewing the initial Submission
  • Introduction: the Reviewing Process (0:50)
  • Search for Information in Dossiers, Documents and Regulatory Activities (1:55)
  • Test: Search for Information
  • The Reviewing Tools - Annotations (2:20)
  • The Reviewing Tools - Highlights (1:40)
  • Security Settings for Highlights and Annotations (0:35)
  • The Annotations Browser (1:20)
  • Test: The Reviewing Tools
  • Story 3: Reviewing follow-up sequences
  • Navigation in the Hierarchy, Working with Favorites (0:40)
  • Test: Navigating in the the Hierarchy Explorer
  • Dossier Lifecycle (0:40)
  • Document Lifecycle (1:40)
  • Lifecycle Views and Filters (0:45)
  • Test: Document Lifecycle
  • Comparing Document Versions in the Lifecycle (1:25)
  • Comparing any two Documents (1:20)
  • "Transparency" of Annotations and Highlights (0:55)
  • Document Comparison
  • 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
  • Story 5: your electronic Assessment Report
  • Your electronic Assessment Report
  • The electronic Assessment Report
  • Story 6: Dossiers with increasing Complexity
  • The "Authorized View Mode"
  • Submission Staging - maintain multiple sequences in the same dossier! (1:30)
  • Story 7: Submission Content Planning & Tracking with eCTDmanager
  • Submission Content Planning and Tracking (2:40)
  • Supported Regional Submission Formats
  • Supported Submission Formats
  • Module 1 – General Information (1:35)
  • The Module 1 for Europe (1:40)
  • eCTD Dossier Lifecycle: examples of follow-up sequences in EU dossiers (2:10)
  • China CDE eCTD Submissions
  • Eurasian Economic Union (EAEU) Applications
  • Japanese eCTD Submissions
  • World Health Organization (WHO) eCTD Submissions
  • eCTD 4.0 Applications
  • Full-text Search for Content in Project, Storages, Dossiers, Submissions
  • Introduction to the new Full-text Search (2:00)
  • Perform a Full-Text Search (4:10)
  • Handling Large Search Results; Exact vs. Partial Matches (1:20)
  • Logical Search Based on Metadata
  • Logical Search Based on Metadata - Introduction (2:35)
  • Open the Search Screen, Creating and Executing a Query (3:55)
  • Logical Search Templates: Executing a Global Query Template (1:35)
  • Custom Attributes
  • Custom Attributes - Introduction (0:55)
  • Prioritization of Custom Attribute Changes (0:45)
  • Visualization of Custom Attributes (1:20)
  • Maintenance of Local Custom Attributes, Pre-defined Custom Attributes (1:05)
  • Adding New Custom Attributes to a selected Element (1:00)
  • Editing Custom Attributes for a selected Element (0:50)
  • Deleting Custom Attributes from a selected Element (1:00)
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete the units "eSUBmanager Log-In (0:30), Test: eSUBmanager first steps, The Content of the Initial Submission (0:45), Open and close a Document, Document Attributes and Lifecycle (0:55), Test: Content of the initial submission, Document Viewer, Search for Information in Dossiers, Documents and Regulatory Activities (1:55), Test: Search for Information, The Reviewing Tools - Annotations (2:20), Test: The Reviewing Tools, Navigation in the Hierarchy, Working with Favorites (0:40), Test: Navigating in the the Hierarchy Explorer, Document Lifecycle (1:40), Test: Document Lifecycle, Comparing Document Versions in the Lifecycle (1:25), 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
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