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eCTD 4.0 Publishing in eSUBmanager


Description
Use eSUBmanager to create and publish submissions to regulatory health authorities. With eSUBmanager,
you can, e.g., start the lifecycle of your medicinal product with the initial marketing authorization in a specific country or region.
After the authority has granted the marketing authorization, the lifecycle of your medicinal product continues with follow-up submissions for, e.g., amendments, renewals, variations, etc.
eSUBmanager supports submission unit compilation and publishing in compliance with the eCTD 4.0 specifications. This includes US FDA eCTD 4.0, EU EMA eCTD 4.0, and JP PMDA eCTD 4.0.

To use the publishing functionality, you must be logged in to eSUBmanager with a user account
that has the Publisher role. Otherwise the functionality is not available.

The overall duration of this e-Learning course is approx. 60 minutes.

(Last Revision Q2/2026)
Content
  • Introduction & Background Information to eCTD 4.0
  • From eCTD v3 to eCTD v4
  • Building Blocks of eCTD v4
  • ICH Background Information
  • The eCTD 4.0 Publishing Module in eSUBmanager
  • eSUBmanager Log-In (0:30)
  • eSUBmanager Online Help & User Guide (0:40)
  • eCTD v4 Publishing in eSUBmanager (1:25)
  • The Publishing Overview; Opening an eCTD v4 Application (1:10)
  • Test: eSUBmanager Publishing 1
  • Creating a new eCTD v4 Application: Publishing Area & Application Attributes
  • Creating a new European eCTD v4 Application (1:20)
  • Maintaining Regional eCTD v4 Metadata (4:55)
  • Creating New Sender-Defined Keywords (1:20)
  • Test: eSUBmanager Publishing 2
  • Submission Unit Page: The Document List
  • Adding the First Documents to the Initial Submission Unit (1:15)
  • Assign new Documents to a Context Group (2:25)
  • Changing the Sorting within the same Context Group (0:30)
  • Filtering & Grouping the Submission Unit Page (1:20)
  • Assigning the same Keywords to multiple CoU’s of the same Context Group (1:00)
  • Adding New Documents to an existing Context Group (1:00)
  • Removing a newly added CoU from a Submission Unit (0:40)
  • Test: eSUBmanager Publishing 3
  • Document Viewer, Document Details Panel
  • Arranging the Panels of the Submission Unit Page (1:30)
  • The Document Details Panel: Check and Maintain CoU metadata (2:45)
  • Opening a Document from a Submission Unit (0:50)
  • Info: Basic Features of the Document Viewer (3:10)
  • Test: eSUBmanager Publishing 4
  • Keywords, CV's and Document Groups
  • Using Keywords and Controlled Vocabularies in M2, M3 (2:30)
  • Using Document Groups: Study Data in M4, M5 (2:10)
  • Test: eSUBmanager Publishing 5
  • Creating & Maintaining Hyperlinks
  • Introduction to Hyperlinks (2:05)
  • Creating Internal Hyperlinks (1:00)
  • Creating external Hyperlinks (1:00)
  • Editing or Deleting a Hyperlink (1:30)
  • Test: eSUBmanager Publishing 6
  • From Pre-Validation to Export
  • Pre-Validation of a Submission Unit (2:45)
  • Finalize / Reopen a Submission Unit (1:10)
  • Exporting a Submission Unit (3:00)
  • Viewing an Exported Submission Unit (0:50)
  • Test: eSUBmanager Publishing 7
  • Lifecycle of an eCTD v4 Application (I)
  • Introduction to Follow-up Submission Units (0:50)
  • Creating a Follow-up Submission Unit (1:15)
  • Maintaining eCTD v4 Application Attributes (1:00)
  • View Modes to Browse Submission Units (1:15)
  • Test: eSUBmanager Publishing 8
  • Context-of-Use Lifecycle Operations
  • Introduction: Context-of-Use Replace Operations (1:15)
  • Performing Replace Lifecycle Operations: "One-to-One", "One to-Many" (2:00)
  • Performing a "Many-to-One" Replace Lifecycle Operation (1:20)
  • Update Operations on CoU and Document Metadata (0:50)
  • Performing a Delete Lifecycle Operation (1:15)
  • The "Re-Use" Replace Life Cycle (0:40)
  • "Re-using" an Existing Document with an additional CoU (1:20)
  • Changing the Document Title via a Related CoU (0:50)
  • Reverting a Lifecycle Operation of a CoU (0:45)
  • Test: eSUBmanager Publishing 9
  • Lifecycle of an eCTD v4 Application (II)
  • Exporting the follow-up Submission Unit (2:15)
  • Creation of New Submissions to Maintain Regulatory Activities (2:35)
  • Test: eSUBmanager Publishing 10
  • Training Evaluation Form
Completion rules
  • You must complete the units "Test: eSUBmanager Publishing 1, Test: eSUBmanager Publishing 2, Test: eSUBmanager Publishing 3, Test: eSUBmanager Publishing 4, Test: eSUBmanager Publishing 5, Test: eSUBmanager Publishing 6, Test: eSUBmanager Publishing 7, Test: eSUBmanager Publishing 8, Test: eSUBmanager Publishing 9, Test: eSUBmanager Publishing 10"
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