Time

Topic

Summary

Speaker/s

9.00-9.20

Opening Remarks

9.20-10.30

National Reforms in Health and Medical Research

Overview of NOSS and broader national reform agenda; alignment with policy and operational change

Prof Ian Chubb, Chair of the Inter-Governmental Policy Reform Group (IGPRG)

 Linda Cristine, Director, NOSS Clinical Trials Policy Section

Health Economics and Research Division

10.30-11.00

Update from the Australian Commission for Safety and Quality in Healthcare.

Suchit Handa

Director, Measurement for Improvement,

The Australian Commission for Safety and Quality in Healthcare.

11.00-11.30

Morning tea

11.30-12.00

From Gatekeeper to Game-Changer: Rethinking Ethics & Governance for Innovation at Scale

In a world where research moves faster than policy, traditional ethics and governance models are struggling to keep pace — slowing innovation, frustrating industry, and risking public trust. This session will show how Australia can flip the script: turning governance from a compliance hurdle into a competitive advantage.

Drawing on real-world case studies and national reform directions, we’ll explore:

• Designing for speed and integrity - how streamlined, risk-based models cut approval times without compromising standards.
• Building trust at the speed of innovation - reframing ethics as a driver of collaboration across sectors.
• Creating a shared national language - so industry, government, and research can work seamlessly together.

Participants will leave with a clear picture of “what good looks like” in next-generation governance, and a roadmap to scale it nationally.

Heidi Gaulke, Director of Operations, Discovery & Innovation Austin Health

12.00-1.00

Early Phase (FIH) Trials – Site Expansion

Capacity building for complex early-phase studies, infrastructure and workforce readiness

Biljana Georgievska, Chief of Commercial Nucleus Network

1.00-2.00

LUNCH

2.00-3.15

Emerging Issues for Sponsors, Sites and CROs

Exploring sponsor–site collaboration, site ranking and payments, system rationalisation, and myth-busting to drive new ways of thinking.

Jane Gaunson, Negin Rahmani, Lucas Litewka, Antonio Hellebuyck

3.15-3.45

Afternoon tea

3.45-4.45

Yarning Up Mob Research – Walk with us

This session explores strategies for inclusive clinical research with Aboriginal and Torres Strait Islander communities, focusing on the Victorian Aboriginal Community Controlled Health Organisation (VACCHO) and the guiding principles of marra mgarrgoo, marra goorri: The Victorian Aboriginal Health, Medical, and Wellbeing Research accord (the accord). We’ll highlight VACCHO’s progress in implementing the Accord and its potential to transform research practices through cultural safety and self-determination. The Flash GM study team will share their proven approach—co-design, collaboration, and connection—demonstrating how these principles drive meaningful partnerships and impactful research outcomes. Attendees will gain practical insights into fostering trust and achieving health equity through culturally informed clinical trials.

Jane Gaunson

Olivia Payne, Mariam Hachem, Bernard Kelly-Edwards

4.45-5.00

Closing Remarks

Tim Boyle