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DOCmanager 2024 - Add-on to eCTDmanager


Description
Hint: This eLearning course has been completely re-designed in 2024!

DOCmanager is the perfect add-on to eCTDmanager!

Users can maintain a master-child relationship between DOCmanager templates and dossiers in eCTDmanager. DOCmanager supports parallel updates on many identical or nearly identical submissions, for example in case of variations or amendments.

A potential business scenario is the generation of several EU national submissions based on one master template. This is very useful for medical devices, where no MRP is allowed. The templates may include a Regional Part, alternatively the Regional Part can also be maintained in the generated children.

Or, a pharmaceutical company maintains several templates for their active substances. Then they can easily generate a combination product based on these templates.

There are no limits! Let’s say, multiple templates contain information about excipients. In the submission compilation phase these excipients are used in several preparations in the child dossiers.
Of course, the benefit of DOCmanager is that you maintain the templates centrally and you don’t have to worry about each individual dossier.

The duration of this course is approx. 15 minutes, this does not include the time for test questions.
Content
  • Introduction
  • Introduction to DOCmanager (0:30)
  • Introduction to the Business Scenario of this e-Learning course (1:55)
  • DOCmanager User Interface (1:30)
  • DOCmanager Test 1
  • Generate a submission from a Template
  • Template Generation - a 4-Step Process (0:30)
  • Creating a New Template (0:25)
  • Adding Documents and Hyperlinks to the Template (0:45)
  • Apply a Template to a Submission (0:45)
  • Generate Submissions from a Template, maintain Regional Part (2:05)
  • DOCmanager Test 2
  • Generation Options
  • DOCmanager Generation Options (0:40)
  • Simulate Submission Generation (0:25)
  • DOCmanager Test 3
  • Document Lifecycles in Templates and Submissions
  • Document Lifecycles in the Template (1:05)
  • Document Lifecycles in the generated Submission (2:10)
  • DOCmanager Test 4
  • Generating Submissions from Multiple Templates (1:30)
  • Other Template-related Features
  • Export Template Versions (0:35)
  • Generating Templates from Submissions (0:35)
  • Save a Template Version as New Template (1:00)
  • Generation Protocolls and Reports (1:25)
  • Archiving / Un-Archiving Templates (0:45)
  • Unfinish a Template Version (0:55)
  • DOCmanager Test 5
  • Training Feedback
  • Training evaluation form
Completion rules
  • You must complete the units "DOCmanager Test 1, DOCmanager Test 2, DOCmanager Test 3, DOCmanager Test 4, DOCmanager Test 5"
  • Leads to a certificate with a duration: 1 year
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