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eCTDmanager Basic Training Course 2024 - Part 1 of 3


Content
  • NEW: What's New in eCTDmanager version 25.06
  • NEW: Overview of Supported eCTD Regions
  • What's New in eCTDmanager version 25.02
  • What's New in eCTDmanager version 24.10
  • Section 1: Introduction - Electronic Submission Management and eCTD Background
  • Course description (1:40)
  • From CTD to eCTD (1:56)
  • Where the eCTD standard is used - the eCTD worldmap (0:55)
  • Structure of the (electronic) CTD (1:15)
  • Required specifications beyond ICH eCTD (0:44)
  • Outlook (1:33)
  • SECTION 2: GETTING FAMILIAR WITH ECTDMANAGER
  • Starting eCTD manager (0:50)
  • The Elementary Terminology of eCTDmanager (0:38)
  • Window Handling and Menus: Basic Operations in the User Interface (1:29)
  • Refresh Project (0:32)
  • Quitting eCTDmanager (0:16)
  • Section 3: creating dossiers and submissions
  • Creating a new Dossier (3:30)
  • Test: Creating a Dossier
  • Other dossier Structures (2:17)
  • Section 4.1: The EU M1 Regional Part
  • NEW: The new EU Module 1 eCTD specification, version 3.1 (3:15)
  • NEW: The new EU Module 1 eCTD specification, version 3.1.1 (1:35)
  • EU Module 1 - The Regional Part (1:17)
  • Adding the EU Module 1.0 documents: Cover Letter & Tracking Table (3:39)
  • EU M1.2: The electronic Application Form (1:14)
  • EU M1.3 Labelling and packaging information (1:29)
  • EU M1: Other documents (0:45)
  • EU M1: The EU envelope section (4:03)
  • Test: EU Module 1
  • Section 4.2: The US-FDA Regional Part
  • Creating a Dossier with US-FDA Module 1 v3.3 (2:35)
  • The US FDA Module 1 - Adding Admin Information (5:00)
  • Module 1 Regional Information: Forms and Cover Letter (1:00)
  • Module 1.14: Adding Structured Product Labeling (SPL) (1:50)
  • Module 1.15: Promotional Material (1:50)
  • Section 4.3: The ZA Regional Part
  • Introduction to the SAHPRA eCTD M1 v. 3.1 (0:25)
  • Create a New Dossier with a ZA M1 v.3.1 (1:45)
  • The ZA Regional Part (0:45)
  • The ZA Envelope (5:35)
  • Adding the ZA M1 Documents - ZA Document Matrix (4:35)
  • The Module 3.2.R Regional Information (0:35)
  • Section 4.4: Examples for Other Regional Parts
  • Example for other Regions: The Gulf Council Countries GCC (3:07)
  • SECTION 5: SPECIFIC SECTIONS, NODE EXTENSIONS, Document operations
  • Working with Specific Sections (1:43)
  • Specific Sections: Abbreviated Directory Attribute (1:20)
  • Manage Documents: Adding Documents from a file share or DMS (2:17)
  • The "Where Used" List (0:35)
  • Working with Placeholders: "Add Interim Document" (1:31)
  • Test: Specific sections, document handling, Interim Documents
  • The Document Explorer: a different view on Documents (0:54)
  • Expand / Collapse Branches (0:43)
  • Working with Node Extensions (1:00)
  • Copy Branch (0:50)
  • Companion Folder Structure for Working Documents (2:55)
  • Section 6: Hyperlinks
  • Introduction: three ways to create hyperlinks
  • Create Hyperlinks manually (2:25)
  • Hyperlinks List (1:54)
  • Edit Hyperlinks (0:51)
  • Replace an Interim Document being a Hyperlink Target (0:35)
  • Option 2: Automatic resolution of externally created Hyperlinks (2:11)
  • Option 3: Create Hyperlink from Text - Introduction (1:25)
  • Create Hyperlink from Text - "Recognize Destination" disabled (1:22)
  • Create Hyperlink from Text - "Recognize Destination" enabled (2:47)
  • Test: Hyperlinks
  • Section 7: Pre-validation, task tracking. Finish and export a Submission
  • How to get the submission to the authorities? (0:52)
  • Validate Submission (1:51)
  • Finish Submission (0:28)
  • What happens during the Submission Export? (0:45)
  • Export an initial submission (1:42)
  • The exported eCTD Submission in the Windows File Explorer (1:13)
  • Compatible Web Browsers (1:10)
  • Validate Business Rules after Export, Transfer to Authority (2:44)
  • Test: pre-validate, finish & export a Submission
  • Section 8: Submission- and Document Lifecycle
  • Submission Lifecycle, Edit Envelope Information in Follow-Up Submissions (1:54)
  • Test: Submission Lifecycle
  • Document Lifecycle and Lifecycle Management Views (4:03)
  • Test: Document Lifecycle
  • Section 9: Other document related features
  • Edit a document in the Document Management System (2:33)
  • Check for a new Document Version in the DMS (1:07)
  • Edit Document Bookmarks (1:19)
  • Test: Edit Document Bookmarks
  • Section 10: WORKING WITH FOLLOW-UP SUBMISSIONS
  • Exporting Follow-Up Submissions (2:06)
  • Lifecyle Icons in follow-up Submissions (0:35)
  • Test: Follow-up-Submissions
  • Section 11: Re-using Dossiers and Submissions
  • The cumulative submission
  • Add/Replace the Module 1 Regional Part (0:47)
  • Test: Re-using Submissions
  • Section 12: Importing eCTD Submissions and Dossiers
  • Import of Submissions - Introduction (2:12)
  • Import single Submissions and Baselines (2:28)
  • Test: Importing Submissions and Dossiers
  • Submission Titles and Comment Fields (1:26)
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete 50.00% of the content
  • Leads to a certificate with a duration: Forever
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