|Address||TOPRA Ltd Bellerive House 3 Muirfield Crescent London E14 9SZ|
This workshop is designed for all industry professionals with little to no experience with eCTD, who are presently, or are planning to be, involved with the development of eCTD submissions. This includes professionals in: Medical Writing, Regulatory Affairs, Dossier and Document Management, IT and
Data Management, Compliance, Publishing and Submission Management.
● CTD/eCTD Basics
● Submission structure and document granularity
● Hyperlinking and templates
● Technical elements of the eCTD
● Working with study files
● Lifecycle management
● Overview of the differences in guidance from different regulatory bodies.
Start of course: 09.30
End of course: 16.45