C05. Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
Tracks
General Interest
| Thursday, June 5, 2025 |
| 9:30 AM - 10:30 AM |
| Parkside 2 |
Chair & Speakers
Jerneen Williams
Director of Operations
Bellberry
Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
Abstract
The international landscape for the regulation of clinical trials is undergoing rapid change. In the United States, the Food and Drug Administration has requirements in place or imminent regarding diversity in clinical trials, artificial intelligence (AI), and platform trials. In the European Union, changes are emerging in areas such as privacy and AI, and a single jurisdictional approach is anticipated to commence in 2028. These international developments are operating alongside a shifting regulatory landscape in Australia, including proposed privacy law amendments and Therapeutic Goods Administration oversight. In this session, Bellberry Human Research Ethics Committee chairs and senior staff will detail national and international regulatory trends and distil their expected implications for Australian clinical trial sponsors and sites. The panel will discuss what the shifting landscape might mean for HREC review of multinational clinical trials, potential ‘pressure points’ for sponsors and sites, and trends to watch out for in the future. The session will conclude with some practical tips and tricks for setting an HREC application up for success.
Biography
Jerneen Williams is the Director of Operations at Bellberry Limited, an independent, not-for-profit organisation providing streamlined scientific and ethical review of Human research projects across Australia. In her role, Jerneen supports the Bellberry team to ensure the consistent delivery of high-quality, efficient review processes.
She holds an Honours degree in Genetics, a Master’s in Clinical Trials Research, an MBA and is a graduate of the Australian Institute of Company Directors. With over 20 years of experience in the clinical trials industry—spanning both public and private research settings—JW brings deep expertise and insight to her leadership. Her work has contributed to multiple peer-reviewed publications, and she remains committed to advancing ethical research practices in Australia’s evolving clinical research landscape.
Chloe Martin
Regulatory and Start Up Manager
St Vincent’s Hospital Sydney
Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
Abstract
The international landscape for the regulation of clinical trials is undergoing rapid change. In the United States, the Food and Drug Administration has requirements in place or imminent regarding diversity in clinical trials, artificial intelligence (AI), and platform trials. In the European Union, changes are emerging in areas such as privacy and AI, and a single jurisdictional approach is anticipated to commence in 2028. These international developments are operating alongside a shifting regulatory landscape in Australia, including proposed privacy law amendments and Therapeutic Goods Administration oversight. In this session, Bellberry Human Research Ethics Committee chairs and senior staff will detail national and international regulatory trends and distil their expected implications for Australian clinical trial sponsors and sites. The panel will discuss what the shifting landscape might mean for HREC review of multinational clinical trials, potential ‘pressure points’ for sponsors and sites, and trends to watch out for in the future. The session will conclude with some practical tips and tricks for setting an HREC application up for success.
Biography
Chloe Martin has over 18 years of experience in healthcare - with more than 10 of those wonderful years playing a significant role within cancer research and clinical trials at St Vincent's Hospital in Sydney.
Chloe was instrumental in the growth of clinical research at The Kinghorn Cancer Centre, developing a successful regulatory team, and managing over 150 lead site HREC applications, and over 300 site specific applications through start-up and beyond.
Her experience spans oncology, haematology and nuclear medicine, with particular emphasis on early phase clinical trials in recent years.
Chloe has worked alongside pharmaceutical sponsors, clinical research organisations, collaborative groups, institutions and investigators on a variety of trials both within Australia and worldwide.
Andrew McLachlan
University of Sydney
Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
Abstract
The international landscape for the regulation of clinical trials is undergoing rapid change. In the United States, the Food and Drug Administration has requirements in place or imminent regarding diversity in clinical trials, artificial intelligence (AI), and platform trials. In the European Union, changes are emerging in areas such as privacy and AI, and a single jurisdictional approach is anticipated to commence in 2028. These international developments are operating alongside a shifting regulatory landscape in Australia, including proposed privacy law amendments and Therapeutic Goods Administration oversight. In this session, Bellberry Human Research Ethics Committee chairs and senior staff will detail national and international regulatory trends and distil their expected implications for Australian clinical trial sponsors and sites. The panel will discuss what the shifting landscape might mean for HREC review of multinational clinical trials, potential ‘pressure points’ for sponsors and sites, and trends to watch out for in the future. The session will conclude with some practical tips and tricks for setting an HREC application up for success.
Biography
Ian Wu
Associate Director Clinical Start-Up Manager, Clinical Operations
Beigene
Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
Abstract
The international landscape for the regulation of clinical trials is undergoing rapid change. In the United States, the Food and Drug Administration has requirements in place or imminent regarding diversity in clinical trials, artificial intelligence (AI), and platform trials. In the European Union, changes are emerging in areas such as privacy and AI, and a single jurisdictional approach is anticipated to commence in 2028. These international developments are operating alongside a shifting regulatory landscape in Australia, including proposed privacy law amendments and Therapeutic Goods Administration oversight. In this session, Bellberry Human Research Ethics Committee chairs and senior staff will detail national and international regulatory trends and distil their expected implications for Australian clinical trial sponsors and sites. The panel will discuss what the shifting landscape might mean for HREC review of multinational clinical trials, potential ‘pressure points’ for sponsors and sites, and trends to watch out for in the future. The session will conclude with some practical tips and tricks for setting an HREC application up for success.
Biography
