Program Overview

The first day of the conference will focus on the significant 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, regulation of medical devices, medical affairs and manufacturing. The day will also include a stream focused on educating and integrating entrepreneurs and innovators.  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.

Updates on clinical evidence requirements, software as a medical device, medicines shortages, cell and gene therapy, update from New Zealand, Listing assessed pathway (AUSTL(A)) pathway & personalised medical devices are planned.

•  Manufacturing 

• Regulatory devices         

• Prescription medicines regulation            

• Non-prescription medicine regulation    

•  Entrepreneurship, innovation & commercialisation (SME and founders)

This day includes the opening reception and networking function.

This day brings in important updates on the impact of the National Medicines Policy, real world evidence from a number of angles as well as the emerging issues in precision and translational medicine. The updates for those working in the regulation of prescription medicines and medical devices will continue with the additional of the clinical research sector update stream. The day will also have dedicated updates for those working in medicine reimbursement. 

Updates on EU MDR, facilitated regulatory pathways, impact of RWE on regulatory and access decision making, National Front Door & One Stop Shop Ethics, precision and translational medicine, facilitated regulatory pathways & accessing and funding of medicines 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.

Educational streams

•  Clinical research update

•   Medical device regulation

•  Prescription medicines regulation            

•   Medicine reimbursement

•   Leadership, wellness & resilience

•  Medical Affairs / MSL

•  R&D innovations

This day includes the “must attend” ARCS Awards dinner & networking function.

Educational streams