Difficult and time-consuming review, physical paper flow, physical archiving and storage spaces – these are only some of the examples of hurdles experienced at the time before 2002 when there was no established common and internationally approved format of the dossier for new registration. At that time, there was a huge need to introduce a common format applicable to various regions across the globe to significantly reduce time and resources needed to compile applications for the registration of medicines and would ease the preparation of electronic submissions. Being familiar with CTD structure and its main characteristics is part of a fundamental knowledge necessary for effective working with a dossier and proper understanding of the regulatory document flow. This course will explain you in more detail Common Technical Document (CTD) format and will present you how this format is organised into five modules. Moreover, you will learn more about NeeS and eCTD, together with their main principles.
By attending this course, you will learn:
- Gain the basic knowledge and important terminology about Common Technical Document (CTD).
- A detailed breakdown of the CTD structure with five modules together with a proper guidelines.
- Get understanding on the NeeS format: overview, main principles, TOC, validation.
- Get understanding on the eCTD format: overview, main principles, validation, how to switch dossier to eCTD, tracking table and sequences, envelope information and eCTD 4.0.
