For anyone in Pharma/Healthcare that isn’t aware, the Therapeutic Goods Administration (TGA) in Australia is moving forwards with the use of submissions in the Electronic Common Technical Document (eCTD) format, with the aim of accepting eCTD submissions in June 2015. Their initial pilot program of the eSubmission application process has now finished, and the final version of the eCTD specifications for Australia can be found here.
The Debenu team will be attending the ARCS Scientific Conference in Sydney, 5-7 May.
If you are going (which you should), make sure to listen to the talk on Wednesday 6 May at 11.15; B7 – “eCTD in Australia and Experience in the Pilot Programme”. There will be an overview from the TGA’s pilot programme, an update of the eCTD specifications for Australia and a look into the technical side of eCTD’s.
The transition to eSubmissions might seem daunting at first. However, there are a range of established publishing tools (Lorenz DocuBridge, eCTD Office, etc) to help you compile your submissions into the right format. On the PDF preparation side of things there is Debenu PDF Aerialist Pharma which dramatically increases the productivity of the regulatory affairs person working on the submission, but also for the reviewer receiving it.
Debenu PDF Aerialist Pharma, an Adobe Acrobat plug-in, allows for the automated addition of TOCs, bookmarks and hyperlinks to the documents, as well as audit reports, ensuring that the standards required are met every time.
Debenu will be at the conference all three days, answering any questions you have about your PDF’s and how we can streamline your workflow to make your documents match the new specifications. Come by the Debenu booth and say hi to the team. We hope to see you there!
