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, we will export this dossier and we will discuss the validation features of eCTDmanager. We will continue this dossier with creating a follow-up submssion and discuss different aspects of the document lifecycle. Importing eCTD submissions is another important topic.

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.

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.