When and how is it necessary to run a clinical trial for a device in Australia?

This presentation is based on two key objectives:

  • To give an understanding of Australia as a place to conduct clinical research
  • An overview of the Clinical Trials requirements in accordance with the Clinical Trails Notification (CTN) scheme and Clinical Trial Exemption (CTX) scheme

Australia is ideally positioned as a place to conduct clinical research for both local manufacturers and international manufacturers.  The spectrum of population and the pilot studies that can be conducted are of great value to any device manufacturer.

A detailed assessment of clinical trial requirements will be presented in addition to the steps required to initiate and maintain a clinical trial. 

Presented by: Roy Hardman