2025 ARCS Clinical Summit: Driving Change Together
Held in partnership with ACTA, the ARCS Clinical Summit is back this November with a focus on collaboration, innovation, and impact in clinical research.
Join us at the ARCS Clinical Summit as we explore key themes shaping the future of clinical research, including First-in-Human trial capability, streamlining ethics and governance, and inclusion of diverse populations in trials. The program will also feature updates from the Australian Commission on Safety and Quality in Health Care and national reform progress, including the National One Stop Shop (NOSS).
Attendees can expect an agenda designed to challenge thinking, spark discussion, and offer practical insights for professionals across the clinical trials landscape.
Whether you're working at a site, within a sponsor organisation, CRO, or government body, this Summit is your opportunity to be part of the conversation shaping the future of clinical research in Australia.
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Time
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Topic
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Summary
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Speaker/s
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9.00-9.20
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Opening Remarks
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9.20-10.30
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National Reforms in Health and Medical Research
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Overview of NOSS and broader national reform agenda; alignment with policy and operational change
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Steve Maillet, Director, Clinical Trials Policy Section
Linda Cristine, Director, NOSS Clinical Trials Policy Section
Health Economics and Research Division
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10.30-11.00
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Update from the Australian Commission for Safety and Quality in Healthcare.
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Driving Change towards 2030
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Suchit Handa
Director, Measurement for Improvement,
The Australian Commission for Safety and Quality in Healthcare.
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11.00-11.30
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Morning tea
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11.30-12.00
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From Gatekeeper to Game-Changer: Rethinking Ethics & Governance for Innovation at Scale
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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.
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Heidi Gaulke, Director of Operations, Discovery & Innovation Austin Health
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12.00-1.00
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Early Phase (FIH) Trials – Site Expansion
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Capacity building for complex early-phase studies, infrastructure and workforce readiness
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Biljana Georgievska, Chief of Commercial Nucleus Network
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1.00-2.00
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LUNCH
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2.00-3.15
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Emerging Issues for Sponsors and CROs
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Exploring sponsor–site collaboration, site ranking and payments, system rationalisation, and myth-busting to drive new ways of thinking.
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Jane Gaunson, Negin Rahmani, Lucas Litewka, Antonio Hellebuyck
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3.15-3.45
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Afternoon tea
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3.45-4.45
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Inclusion of Diverse Populations
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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 Ngarrgoo, 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.
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4.45-5.00
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Closing Remarks
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Tim Boyle
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Agenda is current as of 09 Sep 2025. Subject to change without notice.
Join us as we drive change together on 19th of November 2025.
Register Now Spots are running out fast.
Pricing AUD and inclusive of GST - for the ARCS Summit alone:
ARCS Member Early Bird Registration: $550
ARCS Member Standard registration (after 20 OCT 2025): $700
Non-member registration: $1200
If you would like to attend the ACTA Symposium as well as the ARCS Summit, you will need to register for the ACTA Symposium first. Once registered, delegates will receive a confirmation email with a discounted link enabling registration for the ARCS Clinical Summit.
Note: Become an ARCS member now to enjoy membership benefits including unlocking early bird rates, discounted event prices, complimentary Interest Area webinars, networking and more!