B04 – eCTD: Streamlining submissions to ensure successful outcomes

This session will present and discuss the experiences industry has had with eCTD submissions to date and provide feedback received, both positive and negative. The intent is to give the audience an understanding of what constitutes a successful submission and to ensure common errors are avoided during publishing and submission of eCTD dossiers to TGA.

 

Chairperson: Karolina Chawrylak, Regulatory Operations Manager, Mayne Pharma International