| Course | |||||
|---|---|---|---|---|---|
 | eCTD / eCTD General 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,... | ||||
 | eCTD / eCTD General 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... | ||||
 | eCTD / eCTD USA 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... | ||||
 | eCTD 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,... | ||||
| eCTD / eCTD General 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,... | ||||
| eCTD / eCTD General 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,... | ||||
 | eCTD / eCTD General | ||||
 | eCTD / eCTD General 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... | ||||
 | eCTD / eCTD General 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 / RIM - Regulatory Information Management 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... |
