The eCTD format consists of a hierarchical structure that includes various modules and sections, which are based on the International Council for Harmonization of Technical Requirements for ...

The Common Technical Document is organized into five modules. Module 1 is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions. CTD, Common Technical Document.

Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review ...

From January 2010, the eCTD (electronic Common Technical Document) format became compulsory for all electronic-only submissions via the Centralized Procedure. A recent EU survey revealed that 28% of ...

This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for successful submission. The expert speakers will share their practical ...

The content is based on the Common Technical Document (CTD) format. For more information about Intrasphere's PharmaCM Submissions Managementand Authoring module, contact us at (212) 937-8200.

Global eSubmissions: Join our; interactive round tables to share experiences with EU eCTD Module 1 Specification v3.0; Global Collaboration Zone to overcome challenges with global eCTD requirements; ...

The eCTD format consists of a hierarchical structure that includes various modules and sections, which are based on the International Council for Harmonization of Technical Requirements for ...