Building the eCTD

Filing submissions is a time consuming, laborious task for industry and Regulators alike. The sheer size of each submission leads to costly time delays at every stage of the submission process. Using the eCTD has been proven to speed your data through the approval process, saving you valuable resources and time.

The eCTD has already become mandatory in some countires such as Belgium, and it can only be a matter of time before it is mandatory on a global scale. Will you be ready?

Your regulatory agencies are committed to implemeting the eCTD as standard. Attend this practical 2-day course and ensure you are submitting your applications in the correct electronic format and style from the onset.

• Plan, organise and submit successful eCTDs
• Gain practical insight into how the Regulators review eSubmissions
• Build an eCTD from scratch
• Track and manage multiple agency submissions
• Implement time-saving strategies for streamlining eSubmissions