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
This course targets users who want to get an overview of the eCTDmanager basic features. During this course we will show the complete process of creating an eCTD dossier with an EU Module 1 (we also added an example for another eCTD region,...
eCTDmanager Basic: Additional Features for US FDA Submissions
In the following sessions we’ll focus on US specific features. This course is an enhancement to the eCTDmanager Basic Training course for EU. Topics featured here are: 1) Additional configuration steps in eCTDmanager 2) The US Module 1...
eSUBmanager/EURSnext Basic Training Course (5.0 / 6.0)
"EURSnext" was designed for the assessors and reviewers in health authorities, who have to assess and review the electronically created Sequences with regards to quality, safety and efficacy. "eSUBmanager" is the identical tool for the same use...
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
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
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
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...
EXTEDOpulse (21) - eCTDmanager and eDOCSmanager
This course shows the interaction of eCTDmanager and eDOCSmanager within the EXTEDOpulse suite. The basic training of eCTDmanager is required to understand the features discussed. Even the CARA basic training (part 1) and/or eDOCSmanager...
EXTEDO SafetyEasy™ PV offering is a comprehensive and cost-effective solution designed to streamline pharmacovigilance processes within regulated organizations. It provides the ability to classify, create, review, submit and maintain...
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