Future proofing your Australian human research ethic committee application: Drawing lessons from international regulatory trends
Tracks
Track 3
| Thursday, October 31, 2024 |
| 4:25 PM - 5:10 PM |
Details
The international landscape for the regulation of clinical trials is undergoing rapid change. In the United States, the Food and Drug Administration has new 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, panellists will detail national and international regulatory trends and distil their expected implications for Australian clinical trial sponsors. The panel will discuss what the shifting landscape might mean for HREC review of multinational clinical trials, potential ‘pressure points’ for sponsors, 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.
Speaker
Professor Robyn Langham
Chief Medical Officer TGA (and HREC Chair
Royal Children’s Hospital, Melbourne
Panellist
Dr Beatriz Rocha
Chief Regulatory Liaison Officer
Fortrea
Panellist
A/Prof Michael Ward
Bellberry HREC Chair (and Dean of Programmes (Pharmacy and Biomedical Sciences) UniSA)
Panellist
