Program Overview

The first day of the conference will focus on updates and changes to the regulatory environment in Australia and overseas. The day will provide critical updates for those working in the regulation of prescription and non-prescription medicines, and medical devices. As in past years, we are working with TGA to ensure that the program includes updates from the relevant branches on key projects and activities.  

Updates on GMP clearance, cell and gene therapy, from Medsafe, personalised medical devices, appealing TGA decisions, overseas device and medicines registration pathways, SaMD and risk management are planned. 

This year also sees the reintroduction of a dedicated stream for those working in medical information.  

During the second day, updates and changes affecting those working in the regulation of prescription medicines and medical devices will continue, with the addition of important policy and operational updates for those working in clinical research, medicine reimbursement and pharmacovigilance.  

Updates on the clinical trial landscape, changes to the National Statement, clinical evidence and medical devices, Health Technology Assessment (HTA) review, accessing and funding of medicines, consumer involvement in HTA and the evolving pharmacovigilance landscape and role are planned. 

As in past years, we are working with TGA to ensure that the program includes update from the relevant branches on key projects and activities.