Home / Course catalog / eCTDmanager Basic Training Course 2024 - Part 2 of...


Get this course

eCTD → eCTD General

eCTDmanager Basic Training Course 2024 - Part 2 of 3


Description

Part 2 continues with a discussion on enhanced features, e.g. working with multiple open submissions in parallel. Another EU-specific topic are the tools required to work with EU multinational submissions in MRP and DCP procedures.

Finally, we will discuss additional features like full-text search, reports and annotation features. Here, we will also discuss aspects of eCTDmanager in combination with other Document Management Systems, e.g. eDOCSmanager and Veeva Vault.


In order to complete Part 2 successfully, we recommend that you complete Part 1 first.


Part 3 will cover some basic administration functionalities.

The course covers a basic configuration of eCTDmanager but also including some features of Document Management Systems. Wherever these DMS features are referenced, we will provide a hint.


The course will not cover the installation of the program or advanced configuration options.

Additional courses are available for these topics or for other region-specific features, for example for US submissions. Please contact training@extedo.com for further details.

Content
  • Course description (1:40)
  • Section 13: Submission Staging and regulatory Activities
  • Submission Staging: Working with parallel Submissions (4:28)
  • Structuring your Dossier with Regulatory Activities (2:34)
  • Test: Submission Staging
  • Section 14: EU multinational procedures - MRP and DCP
  • Introduction to Multinational Procedures (0:42)
  • Roll-out the National Authorisation to other Countries (1:31)
  • Add additional countries: Multiple ways to work with Module 1 Elements (2:07)
  • Country Filters for MRP and DCP (3:27)
  • Test: MRP and DCP
  • Section 15: Additional Features
  • Full-text Search (1:45)
  • Generate Reports (1:07)
  • Submission QC Export (1:06)
  • Project Filter Settings: Show / Hide archived Objects (0:57)
  • Nested Specific Sections (2:54)
  • Attribute "Node Extension Export" (0:57)
  • Test: Reviewing Tools
  • Section 18: eCTDmanager in the EXTEDO Suite
  • eCTDmanager and eDOCSmanager: Introduction and Overview
  • Section 19: eCTDmanager and Veeva Vault
  • Introduction: eCTDmanager and Veeva Vault (1:20)
  • Adding Last Minute Documents to Veeva Vault (1:10)
  • Adding Documents from Veeva Vault to eCTDmanager (0:40)
  • Working with Binders and Content Plans (1:35)
  • Drag and Drop Veeva Vault Binders to eCTDmanager (1:15)
  • Check for New Documents (1:05)
  • Check for New Document Versions in Veeva Vault (0:30)
  • The Veeva Vault Submissions Archive (2:20)
  • Creating Source Relationships for Uploaded Submission Documents (1:40)
  • Working with multiple Vaults (1:05)
  • Training Feedback
  • Training Evaluation Form
Completion rules
  • You must complete 50.00% of the content
  • Leads to a certificate with a duration: 1 year
Back