A04a. Cross Border Collaboration
Tracks
Prescription Medicine Regulation
| Tuesday, June 3, 2025 |
| 11:15 AM - 12:15 PM |
| C2.4 |
Chair & Speakers
Tam Nguyen
Deputy Director of Research
St Vincent’s Hospital Melbourne
Cross Border Collaboration
Abstract
Australia stands out as a prime destination for clinical trials, offering a streamlined regulatory process without the need for an IND, coupled with a diverse patient pool ideal for early-phase studies. The high-quality data from clinical trials in Australia holds significant weight and acceptance with key health authorities like the FDA and EMA.
Many countries have taken these advantages, including China, which has recognised the benefits of collaboration. The presentation provides detailed comparison of regulatory frameworks between China and Australia sheds light on the nuances and similarities in their approaches.
A case study showcases the collaborative efforts between St Vincent's Hospital Melbourne, Beigene, and Beigene's local site partners. This strategic partnership focuses on a range of knowledge exchange initiatives, including multi-centre clinical trials, specialised training programs for study coordinators and principal investigators, and specifically enhancing clinical trials data quality.
Many countries have taken these advantages, including China, which has recognised the benefits of collaboration. The presentation provides detailed comparison of regulatory frameworks between China and Australia sheds light on the nuances and similarities in their approaches.
A case study showcases the collaborative efforts between St Vincent's Hospital Melbourne, Beigene, and Beigene's local site partners. This strategic partnership focuses on a range of knowledge exchange initiatives, including multi-centre clinical trials, specialised training programs for study coordinators and principal investigators, and specifically enhancing clinical trials data quality.
Biography
Associate Professor Tam Nguyen has 25 years of experience spanning clinical trials, health and medical research and research innovation sector including tertiary teaching hospitals, medical research institutes and universities across Australia.
Tam is the deputy director of research at St Vincent’s Hospital Melbourne, responsible for research strategy, research development, research ethics and governance, innovation and partnership. Tam serves as non-executive director & advisor to several medtech and health tech start-ups + scale ups.
Tam holds academic appointments with Melbourne Medical School and Monash Medical School.
Tam is a regular invited speaker on a broad range of topics on Clinical trials, Innovation, Industry Collaboration. He chairs and serves on program committee at numerous national and international conferences.
Qiao Watkins
Beigene
A04a. Cross Border Collaboration
Abstract
Australia stands out as a prime destination for clinical trials, offering a streamlined regulatory process without the need for an IND, coupled with a diverse patient pool ideal for early-phase studies. The high-quality data from clinical trials in Australia holds significant weight and acceptance with key health authorities like the FDA and EMA.
Many countries have taken these advantages, including China, which has recognised the benefits of collaboration. The presentation provides detailed comparison of regulatory frameworks between China and Australia sheds light on the nuances and similarities in their approaches.
A case study showcases the collaborative efforts between St Vincent's Hospital Melbourne, Beigene, and Beigene's local site partners. This strategic partnership focuses on a range of knowledge exchange initiatives, including multi-centre clinical trials, specialised training programs for study coordinators and principal investigators, and specifically enhancing clinical trials data quality.
Many countries have taken these advantages, including China, which has recognised the benefits of collaboration. The presentation provides detailed comparison of regulatory frameworks between China and Australia sheds light on the nuances and similarities in their approaches.
A case study showcases the collaborative efforts between St Vincent's Hospital Melbourne, Beigene, and Beigene's local site partners. This strategic partnership focuses on a range of knowledge exchange initiatives, including multi-centre clinical trials, specialised training programs for study coordinators and principal investigators, and specifically enhancing clinical trials data quality.
Biography
Qiao is an experienced executive management and clinical research professional with over 20 years of industry experience in clinical research organisations, pharmaceutical companies, and academic institutions.
Over the years, Qiao has held in a number of roles in clinical, quality, project and people management. Qiao led a business unit that specialised in the delivery of early phase clinical trials that gave her the opportunity to work with a wide cross-section of the health sector and to promote the conduct of clinical trials in Australia.
Qiao enjoys building high performing teams and engaging stakeholders include clinicians, researchers, state and federal government agencies, c-suite executives, industry elites, biotech companies, and advocacy groups.
