Top 10 Clinical Trial Mistakes: How to Avoid the Legal Pitfalls

AusBiotech has several fora in which industry issues are discussed with the TGA. These include a CEO forum, the Industry Consultative Committee, the Technical and Regulatory Committee, the Medical Devices Technical Experts Reference Group, and other ad hoc opportunities. The TGA has published its plans for the long-awaited new regulatory framework for in vitro diagnostic devices (IVDs). The system will use a conformity assessment model closely aligned with the European/GHTF systems, with risk-based classifications determining the level of regulatory review. The TGA plans an end of 2009 implementation date with a four-year transition period before the new framework becomes mandatory. In theory, this is a relatively simple change in regulations only, with no need to change the Therapeutic Goods Act. However, the 'devil' is always in the detail and it remains to be seen if this target will be met.