Conducting clinical trials in Australia – What every sponsor should know

Conducting clinical trials in Australia – What every sponsor should know

Australia has become a leading destination for early-phase and investigator-led clinical trials — thanks to its strong regulatory framework, skilled researchers, and efficient ethics approval processes. However, to conduct a clinical trial successfully, sponsors must understand their responsibilities, key stakeholders, and the pathways available through the Therapeutic Goods Administration (TGA). 1. Setting the Foundation for … Read more

Pitfalls during GCP inspections by TGA and how to avoid them

GCP Inspection Program was introduced by TGA in 2022 with objective to straighten the TGA’s monitoring activities and protect the safety and well-being of the clinical trial participants participating in phase 1 to 3 clinical trials. The program not only ensures compliance with regulatory and ethical requirements (Therapeutic Goods Act 1989, Therapeutic Goods Regulation 1990, … Read more