eCTD in Australia: key steps to start a successful submission

General Information

Full Title: eCTD in Australia: key steps to start a successful submission

Date:  June 28, 2022

Time: 8:30 am CET / 4:30 PM AEST

Duration: 1 hour(s)

Key Learnings

• Know the structure of the Australian eCTD template
•   Understand the administrative information in module 1 (envelope)
•   Know how to create a lifecycle for your Australian submission and what to consider in it
•   Know how to reuse available submission elements from existing (EU) submissions