B7 – eCTD in Australia and Experience in the Pilot Programme

There will be an overview from a company that actively took part in the pilot programme for eCTD in Australia and their review of the process, challenges and points to consider in the future. There will also be an explanation of common eCTD terms and technical aspects that can seem confusing. These will be simplified and explained in such a way that makes sense to day to day business processes that are impacted by the eCTD format.

The TGA will provide an update on the latest Australian eCTD Specification and guidelines, as well as provide commentary on experiences during the pilot programme, how sponsors can improve their electronic submissions and an update to NeeS.

 

Chairperson: Paul Summerville, Allergan