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DOCmanager 2024 - Add-on to eCTDmanager
eCTD
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eCTD General
DOCmanager 2024 - Add-on to eCTDmanager
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,...
eCTDmanager Basic Training Course (2024): Additional Features for US FDA Submissions
eCTD
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eCTD USA
eCTDmanager Basic Training Course (2024): Additional Features for US FDA Submissions
The US FDA submission standards are based on the worldwide accepted eCTD format. Documentation requirements and the modular structure of the FDA eCTD are almost the same as for a European eCTD. However, the FDA has some specific requirements...
eCTDmanager Basic Training Course 2024 - Part 1 of 3
eCTD
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eCTD General
eCTDmanager Basic Training Course 2024 - Part 1 of 3
In Part 1, we will go through the very basics of eCTDmanager. We will cover the complete process of creating an ECTD dossier with an EU Module 1. This dossier will be developed by adding sections, node extensions, documents, and hyperlinks. Then,...
eCTDmanager Basic Training Course 2024 - Part 2 of 3
eCTD
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eCTD General
eCTDmanager Basic Training Course 2024 - Part 2 of 3
In Part 1, we will go through the very basics of eCTDmanager. We will cover the complete process of creating an ECTD dossier with an EU Module 1. This dossier will be developed by adding sections, node extensions, documents, and hyperlinks. Then,...
eCTDmanager Basic Training Course 2024 - Part 3 of 3 (Administration)
eCTD
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eCTD General
eCTDmanager Basic Training Course 2024 - Part 3 of 3 (Administration)
In Part 1, we will go through the very basics of eCTDmanager. We will cover the complete process of creating an ECTD dossier with an EU Module 1. This dossier will be developed by adding sections, node extensions, documents, and hyperlinks. Then,...
eSUBmanager/EURSnext Basic Training Course
eCTD
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eCTD General
eSUBmanager/EURSnext Basic Training Course
EURS - The EXTEDO Universal Reviewing System
eCTD
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eCTD General
EURS - The EXTEDO Universal Reviewing System
The reviewing of electronic submissions upon receipt is a critical process for regulatory authorities. EXTEDO EURS provides you with tools for the validation, acceptance, import, review and maintenance of eCTD, NeeS-based and non-eCTD...
EURSValidator Global Basic Training
eCTD
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eCTD General
EURSValidator Global Basic Training
Before you submit your sequences to the health authorities, you must ensure that you comply with their regulatory standards. If you fail to comply with any of their validation criteria, your submission might be rejected by the authority. The...
EXTEDOpulse (10) - Basic introduction to the EXTEDOpulse platform powered by CARA v. 5.6
EXTEDOpulse
EXTEDOpulse (10) - Basic introduction to the EXTEDOpulse platform powered by CARA v. 5.6
Part 1: Start and Login to EXTEDOpulse Introduction to the EXTEDOpulse User Interface, Learn the Basic Components of EXTEDOpulse. The course has a duration of approx. 25 Minutes. This course now shows the EXTEDOpulse version on CARA...
EXTEDOpulse (20) - eDOCSmanager "Regulatory" Module
EXTEDOpulse
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DMS - Document Management
EXTEDOpulse (20) - eDOCSmanager "Regulatory" Module
This course is part of the EXTEDOpulse eLearning and covers the eDOCSmanager. EXTEDOpulse is powered by the CARA content management platform. It is fast, highly configurable, and user-friendly. EXTEDOpulse can be used to manage content-less...

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