Tuesday, June 3, 2025

GxP Principles
Reimbursement/Market Access
Prescription Medicine Regulation
Medical Devices Regulation Summit
Medical Operations
Leadership, Wellness & Resilience
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A02. Branch update: Manufacturing quality and GMP clearances A03. Horizon Scanning and HTA: Past, Present and Future A04a. Cross Border Collaboration A05a. Navigating the Evolving Landscape of Implantable Medical Device Regulation in Australia A06. Maximising the Impact of Medical Information Services in Business A07. The Neuropsychology of Compliance: Why GxP & Regulatory Training is Failing—And How to Fix It for Good
A05b. China & Hong Kong medical device & IVD registrations: top tips and latest updates
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A08. Contracts and Agreements - the fundamentals A09. HTA Reform A10. Medsafe updates A11. Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices A12. Medical Information in the Post-Pandemic Era: Embracing Change for the Future A13. Squeeze life or life will squeeze you: High Performance Strategies
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A14a. Compliance, Quality Maturity and the CDMO: Navigating Challenges in a Multi-Stakeholder Environment A15. Prescribed List Assessment Processes: An Evaluation A16. Navigating the Transition from Provisional to Full Approval: Insights from TGA and Medsafe A17. TGA Reforms and implications for Medical Device Sponsors A18. A spotlight on Medical Operations in Pharma A19. Leadership Excellence in Regulatory Affairs and Beyond: Advancing Action Logics and Leadership Influence
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A20a. Barriers to harmonisation/post approval challenges and trends in new technology/sustainability A21. Medicine Access: Innovation in Action A22. Checks and Balances: Navigating Internal and External Reviews under the Therapeutic Goods Act A23. CAR-T and radiopharmaceuticals: legal, ethical and regulatory issues impacting the new wave of medical treatments A24. BALANCE and Consistency with the PI: Where’s the Line? A25. Cultural Competence in a Globalized Workplace: Enhancing your effectiveness for better results
A20b. Building a Resilient Startup in the Diagnostic Device Market: Lessons Learned from Failures in Self-Test Devices
5:30 PM - 6:30 PM Welcome Reception
GxP Principles
Reimbursement/Market Access
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A02. Branch update: Manufacturing quality and GMP clearances A03. Horizon Scanning and HTA: Past, Present and Future
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A08. Contracts and Agreements - the fundamentals A09. HTA Reform
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A14a. Compliance, Quality Maturity and the CDMO: Navigating Challenges in a Multi-Stakeholder Environment A15. Prescribed List Assessment Processes: An Evaluation
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A20a. Barriers to harmonisation/post approval challenges and trends in new technology/sustainability A21. Medicine Access: Innovation in Action
A20b. Building a Resilient Startup in the Diagnostic Device Market: Lessons Learned from Failures in Self-Test Devices
5:30 PM - 6:30 PM Welcome Reception

Prescription Medicine Regulation
Medical Devices Regulation Summit
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A04a. Cross Border Collaboration A05a. Navigating the Evolving Landscape of Implantable Medical Device Regulation in Australia
A05b. China & Hong Kong medical device & IVD registrations: top tips and latest updates
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A10. Medsafe updates A11. Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A16. Navigating the Transition from Provisional to Full Approval: Insights from TGA and Medsafe A17. TGA Reforms and implications for Medical Device Sponsors
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A22. Checks and Balances: Navigating Internal and External Reviews under the Therapeutic Goods Act A23. CAR-T and radiopharmaceuticals: legal, ethical and regulatory issues impacting the new wave of medical treatments
5:30 PM - 6:30 PM Welcome Reception

Medical Operations
Leadership, Wellness & Resilience
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A06. Maximising the Impact of Medical Information Services in Business A07. The Neuropsychology of Compliance: Why GxP & Regulatory Training is Failing—And How to Fix It for Good
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A12. Medical Information in the Post-Pandemic Era: Embracing Change for the Future A13. Squeeze life or life will squeeze you: High Performance Strategies
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A18. A spotlight on Medical Operations in Pharma A19. Leadership Excellence in Regulatory Affairs and Beyond: Advancing Action Logics and Leadership Influence
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A24. BALANCE and Consistency with the PI: Where’s the Line? A25. Cultural Competence in a Globalized Workplace: Enhancing your effectiveness for better results
5:30 PM - 6:30 PM Welcome Reception

GxP Principles
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A02. Branch update: Manufacturing quality and GMP clearances
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A08. Contracts and Agreements - the fundamentals
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A14a. Compliance, Quality Maturity and the CDMO: Navigating Challenges in a Multi-Stakeholder Environment
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A20a. Barriers to harmonisation/post approval challenges and trends in new technology/sustainability
A20b. Building a Resilient Startup in the Diagnostic Device Market: Lessons Learned from Failures in Self-Test Devices
5:30 PM - 6:30 PM Welcome Reception

Reimbursement/Market Access
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A03. Horizon Scanning and HTA: Past, Present and Future
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A09. HTA Reform
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A15. Prescribed List Assessment Processes: An Evaluation
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A21. Medicine Access: Innovation in Action
5:30 PM - 6:30 PM Welcome Reception

Prescription Medicine Regulation
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A04a. Cross Border Collaboration
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A10. Medsafe updates
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A16. Navigating the Transition from Provisional to Full Approval: Insights from TGA and Medsafe
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A22. Checks and Balances: Navigating Internal and External Reviews under the Therapeutic Goods Act
5:30 PM - 6:30 PM Welcome Reception

Medical Devices Regulation Summit
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A05a. Navigating the Evolving Landscape of Implantable Medical Device Regulation in Australia
A05b. China & Hong Kong medical device & IVD registrations: top tips and latest updates
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A11. Shaping the Future: Converging Regulatory Frameworks and Preparing for Disruptive Technologies in Medical Devices
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A17. TGA Reforms and implications for Medical Device Sponsors
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A23. CAR-T and radiopharmaceuticals: legal, ethical and regulatory issues impacting the new wave of medical treatments
5:30 PM - 6:30 PM Welcome Reception

Medical Operations
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A06. Maximising the Impact of Medical Information Services in Business
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A12. Medical Information in the Post-Pandemic Era: Embracing Change for the Future
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A18. A spotlight on Medical Operations in Pharma
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A24. BALANCE and Consistency with the PI: Where’s the Line?
5:30 PM - 6:30 PM Welcome Reception

Leadership, Wellness & Resilience
9:00 AM - 9:15 AM A01a. Opening Address
9:15 AM - 9:30 AM A01b. Discovery and Understanding of Country
9:30 AM - 10:00 AM A01c. Interactions with the Smith Family Tertiary Program
10:00 AM - 10:30 AM A01d. Update from TGA to Sector
10:30 AM - 11:15 AM Morning Tea (3rd June)
11:15 AM - 12:15 PM A07. The Neuropsychology of Compliance: Why GxP & Regulatory Training is Failing—And How to Fix It for Good
12:15 PM - 1:30 PM
Lunch (3rd June)
1:30 PM - 2:30 PM A13. Squeeze life or life will squeeze you: High Performance Strategies
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A19. Leadership Excellence in Regulatory Affairs and Beyond: Advancing Action Logics and Leadership Influence
3:45 PM - 4:30 PM
Afternoon Tea (3rd June) - D3. RAPS - Driving Professional Excellence in Regulatory Affairs
D03. RAPS - Driving Professional Excellence in Regulatory Affairs
4:30 PM - 5:30 PM A25. Cultural Competence in a Globalized Workplace: Enhancing your effectiveness for better results
5:30 PM - 6:30 PM Welcome Reception

Wednesday, June 4, 2025

Clinical Research
Clinical & Regulation
Prescription & Non-prescription Medicines Regulation
Reimbursement/Market Access
Data, Technology and Informatics
Pharmacovigilance
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B02. TGA Clinical Trial Initiatives B03. Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial B04a. Preparing an effective listed medicines efficacy package B05a. Navigating Market Access for Medical Devices: Challenges and Opportunities in a Changing Landscape B06. AI in Action: Bridging Innovation and Practicality in Clinical Trials B07.Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
B04b. Vaping reform implementation challenges B05b. Bridging the Gap: The Vital role of field market access in medical devices Driving Patient Access and Innovation in Healthcare
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B08a.Quality Standards for HRECs and their Host Institutions B09. How to Retain Clinical Trial Participants, and What to Do if You Don’t B10. Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways B11. Building Cross-functional Excellence B12. The cost of research: Understanding trial budget variability and maximising benefits through CTMS B13. Update from the TGA Pharmacovigilance Branch
B08b. Navigating New Zealand’s Evolving Clinical Trials Landscape
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B14. How Clinical Trial Service Providers Influence Outcomes B15a. The NSW Health Research Handbook - building a research-enabling culture B16. Prescription Medicine Branch annual update B17. Executing Without Boundaries B18a. Secondary use of clinical trials data in health research: A Practical Guide B19a. Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
B15b. ICH GCP R3: Changes, Flexibility and Challenges B18b. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks B19b. Relevance of ISO 9001:2015 for pharmacovigilance systems
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B20. Advancing Diversity, Equity & Inclusion in Clinical Trials: Bridging the Gap Between Sponsors and Sites B21. Clinical-Regulation considerations when conducting cell therapy clinical trials B22a. Update from the Complementary and Over the Counter Medicines Branch at TGA B23. Future Horizons: Professional Evolution B24. Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients! B25. Automating PV workflows through AI to improve reporting compliance
B22b. Understanding Herbal Raw Ingredients in Complementary Medicines
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner
Clinical Research
Clinical & Regulation
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B02. TGA Clinical Trial Initiatives B03. Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B08a.Quality Standards for HRECs and their Host Institutions B09. How to Retain Clinical Trial Participants, and What to Do if You Don’t
B08b. Navigating New Zealand’s Evolving Clinical Trials Landscape
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B14. How Clinical Trial Service Providers Influence Outcomes B15a. The NSW Health Research Handbook - building a research-enabling culture
B15b. ICH GCP R3: Changes, Flexibility and Challenges
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B20. Advancing Diversity, Equity & Inclusion in Clinical Trials: Bridging the Gap Between Sponsors and Sites B21. Clinical-Regulation considerations when conducting cell therapy clinical trials
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Prescription & Non-prescription Medicines Regulation
Reimbursement/Market Access
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B04a. Preparing an effective listed medicines efficacy package B05a. Navigating Market Access for Medical Devices: Challenges and Opportunities in a Changing Landscape
B04b. Vaping reform implementation challenges B05b. Bridging the Gap: The Vital role of field market access in medical devices Driving Patient Access and Innovation in Healthcare
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B10. Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways B11. Building Cross-functional Excellence
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B16. Prescription Medicine Branch annual update B17. Executing Without Boundaries
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B22a. Update from the Complementary and Over the Counter Medicines Branch at TGA B23. Future Horizons: Professional Evolution
B22b. Understanding Herbal Raw Ingredients in Complementary Medicines
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Data, Technology and Informatics
Pharmacovigilance
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B06. AI in Action: Bridging Innovation and Practicality in Clinical Trials B07.Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B12. The cost of research: Understanding trial budget variability and maximising benefits through CTMS B13. Update from the TGA Pharmacovigilance Branch
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B18a. Secondary use of clinical trials data in health research: A Practical Guide B19a. Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
B18b. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks B19b. Relevance of ISO 9001:2015 for pharmacovigilance systems
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B24. Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients! B25. Automating PV workflows through AI to improve reporting compliance
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Clinical Research
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B02. TGA Clinical Trial Initiatives
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B08a.Quality Standards for HRECs and their Host Institutions
B08b. Navigating New Zealand’s Evolving Clinical Trials Landscape
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B14. How Clinical Trial Service Providers Influence Outcomes
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B20. Advancing Diversity, Equity & Inclusion in Clinical Trials: Bridging the Gap Between Sponsors and Sites
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Clinical & Regulation
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B03. Bumps along the clinical trial journey: dealing with challenges in obtaining ethics / governance approval and problems that may impact a clinical trial
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B09. How to Retain Clinical Trial Participants, and What to Do if You Don’t
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B15a. The NSW Health Research Handbook - building a research-enabling culture
B15b. ICH GCP R3: Changes, Flexibility and Challenges
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B21. Clinical-Regulation considerations when conducting cell therapy clinical trials
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Prescription & Non-prescription Medicines Regulation
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B04a. Preparing an effective listed medicines efficacy package
B04b. Vaping reform implementation challenges
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B10. Driving Efficiency Through Collaborative Regulatory Frameworks: Industry Insights on Expedited Approval Pathways
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B16. Prescription Medicine Branch annual update
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B22a. Update from the Complementary and Over the Counter Medicines Branch at TGA
B22b. Understanding Herbal Raw Ingredients in Complementary Medicines
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Reimbursement/Market Access
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B05a. Navigating Market Access for Medical Devices: Challenges and Opportunities in a Changing Landscape
B05b. Bridging the Gap: The Vital role of field market access in medical devices Driving Patient Access and Innovation in Healthcare
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B11. Building Cross-functional Excellence
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B17. Executing Without Boundaries
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B23. Future Horizons: Professional Evolution
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Data, Technology and Informatics
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B06. AI in Action: Bridging Innovation and Practicality in Clinical Trials
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B12. The cost of research: Understanding trial budget variability and maximising benefits through CTMS
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B18a. Secondary use of clinical trials data in health research: A Practical Guide
B18b. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B24. Decentralized Clinical Trials (DCT) – welcome to the DCT steamboat, select your favourite ingredients!
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Pharmacovigilance
9:00 AM - 9:30 AM B01a. ARCS updates
9:30 AM - 10:30 AM B01b. How rapid and continuous change is reshaping healthcare in Australia
10:30 AM - 11:15 AM Morning Tea (4th June)
11:15 AM - 12:15 PM B07.Australia: A Strategic Gateway for Pharmacovigilance Leadership in APAC
12:15 PM - 1:30 PM Lunch (4th June)
12:30 PM - 1:15 PM B07b. QPPV Forum
1:30 PM - 2:30 PM B13. Update from the TGA Pharmacovigilance Branch
2:30 PM - 2:45 PM
Session Change-over (4th June)
2:45 PM - 3:45 PM B19a. Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
B19b. Relevance of ISO 9001:2015 for pharmacovigilance systems
3:45 PM - 4:30 PM Afternoon Tea (4th June)
4:30 PM - 5:30 PM B25. Automating PV workflows through AI to improve reporting compliance
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Awards Dinner

Thursday, June 5, 2025

Clinical Research
Diversity, Inclusiveness and Consumer Engagement
BioBeacon Drug Discovery Forum
General Interest
Leadership, Wellness & Resilience
Government Updates
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C02. Bridging the gap: Building Competency of the Clinical Research Workforce C03. Considering Historic, Current and Planned Work in Relation to Patient Diversity and Inclusion in Clinical Research C04. NSW early drug discovery forum - Neurological and CNS Disorders C05. Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends C06. Successful Negotiation and Leadership in the Medtech & Pharma Sector C07. National reforms to improve the health and medical research operating environment including National One Stop Shop (NOSS)
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C08. Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia C09a. Enhancing Patient-Centricity in Clinical Research: Leveraging Innovation and Engagement to Improve Outcomes C10. NSW early drug discovery forum - Session 1: Neurological and CNS Disorders
 		C11. Precision Medicine- the transformative power of education on delivering on innovation C12. Mentorship: a powerful tool for effective and inclusive leaders C13. Updates on the implementation of the National Clinical Trials Governance Framework
C09b. Variances, Complexities and Individualised Care in CRPS-
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C14a. Common challenges and practical solutions for clinical trial sites and sponsors – What has changed in the past year? C15. Codesign in Medication Safety Research C16. NSW early drug discovery forum - Session 3: Oncology C17. Emerging technology and emerging leaders - balancing culture and quality in the face of rapid process change C18. Confident Conversations: Turn Difficult Discussions Into Your Superpower C19. NSW Health Research and Innovation Strategy
C14b. Global Accreditation Standards and Australia’s First Certified Clinical Research Site Network
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C20a. Unlocking opportunities for Australia−China collaboration in clinical trials C21a. A Clinical trials closer to home: Building digital infrastructure for GCP compliance to improve clinical trial access and inclusivity for regional, rural, and remote patients C22. NSW early drug discovery forum - Session 4: Cardiometabolic
 		C23. Securing innovations assisted by AI: navigating the patent maze C24. Leadership, Wellness, and Resilience in Clinical Trials: Strategies for Sustaining High-Performance Teams C25a. QLD state update
C20b. Better together: collaboration between teletrial programs in Victoria brings results C21b. Working with Patient and Consumer groups - MasterClass C25b. Q&A panel Government Panel
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
C27. NSW early drug discovery forum - Session 5: Other
5:30 PM - 6:30 PM Closing Reception
Clinical Research
Diversity, Inclusiveness and Consumer Engagement
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C02. Bridging the gap: Building Competency of the Clinical Research Workforce C03. Considering Historic, Current and Planned Work in Relation to Patient Diversity and Inclusion in Clinical Research
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C08. Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia C09a. Enhancing Patient-Centricity in Clinical Research: Leveraging Innovation and Engagement to Improve Outcomes
C09b. Variances, Complexities and Individualised Care in CRPS-
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C14a. Common challenges and practical solutions for clinical trial sites and sponsors – What has changed in the past year? C15. Codesign in Medication Safety Research
C14b. Global Accreditation Standards and Australia’s First Certified Clinical Research Site Network
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C20a. Unlocking opportunities for Australia−China collaboration in clinical trials C21a. A Clinical trials closer to home: Building digital infrastructure for GCP compliance to improve clinical trial access and inclusivity for regional, rural, and remote patients
C20b. Better together: collaboration between teletrial programs in Victoria brings results C21b. Working with Patient and Consumer groups - MasterClass
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

BioBeacon Drug Discovery Forum
General Interest
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C04. NSW early drug discovery forum - Neurological and CNS Disorders C05. Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C10. NSW early drug discovery forum - Session 1: Neurological and CNS Disorders
 		C11. Precision Medicine- the transformative power of education on delivering on innovation
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C16. NSW early drug discovery forum - Session 3: Oncology C17. Emerging technology and emerging leaders - balancing culture and quality in the face of rapid process change
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C22. NSW early drug discovery forum - Session 4: Cardiometabolic
 		C23. Securing innovations assisted by AI: navigating the patent maze
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
C27. NSW early drug discovery forum - Session 5: Other
5:30 PM - 6:30 PM Closing Reception

Leadership, Wellness & Resilience
Government Updates
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C06. Successful Negotiation and Leadership in the Medtech & Pharma Sector C07. National reforms to improve the health and medical research operating environment including National One Stop Shop (NOSS)
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C12. Mentorship: a powerful tool for effective and inclusive leaders C13. Updates on the implementation of the National Clinical Trials Governance Framework
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C18. Confident Conversations: Turn Difficult Discussions Into Your Superpower C19. NSW Health Research and Innovation Strategy
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C24. Leadership, Wellness, and Resilience in Clinical Trials: Strategies for Sustaining High-Performance Teams C25a. QLD state update
C25b. Q&A panel Government Panel
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

Clinical Research
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C02. Bridging the gap: Building Competency of the Clinical Research Workforce
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C08. Innovation in Early-Phase Clinical Trials: Bridging the Gap to Later Phases in Australia
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C14a. Common challenges and practical solutions for clinical trial sites and sponsors – What has changed in the past year?
C14b. Global Accreditation Standards and Australia’s First Certified Clinical Research Site Network
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C20a. Unlocking opportunities for Australia−China collaboration in clinical trials
C20b. Better together: collaboration between teletrial programs in Victoria brings results
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

Diversity, Inclusiveness and Consumer Engagement
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C03. Considering Historic, Current and Planned Work in Relation to Patient Diversity and Inclusion in Clinical Research
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C09a. Enhancing Patient-Centricity in Clinical Research: Leveraging Innovation and Engagement to Improve Outcomes
C09b. Variances, Complexities and Individualised Care in CRPS-
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C15. Codesign in Medication Safety Research
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C21a. A Clinical trials closer to home: Building digital infrastructure for GCP compliance to improve clinical trial access and inclusivity for regional, rural, and remote patients
C21b. Working with Patient and Consumer groups - MasterClass
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

BioBeacon Drug Discovery Forum
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C04. NSW early drug discovery forum - Neurological and CNS Disorders
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C10. NSW early drug discovery forum - Session 1: Neurological and CNS Disorders
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C16. NSW early drug discovery forum - Session 3: Oncology
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C22. NSW early drug discovery forum - Session 4: Cardiometabolic
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
C27. NSW early drug discovery forum - Session 5: Other
5:30 PM - 6:30 PM Closing Reception

General Interest
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C05. Future proofing your Australian Human Research Ethic Committee application: Drawing lessons from international regulatory trends
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C11. Precision Medicine- the transformative power of education on delivering on innovation
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C17. Emerging technology and emerging leaders - balancing culture and quality in the face of rapid process change
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C23. Securing innovations assisted by AI: navigating the patent maze
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

Leadership, Wellness & Resilience
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C06. Successful Negotiation and Leadership in the Medtech & Pharma Sector
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C12. Mentorship: a powerful tool for effective and inclusive leaders
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C18. Confident Conversations: Turn Difficult Discussions Into Your Superpower
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C24. Leadership, Wellness, and Resilience in Clinical Trials: Strategies for Sustaining High-Performance Teams
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

Government Updates
8:00 AM - 9:00 AM International trade opportunities for NSW’s life sciences and healthcare industries
Presented by Investment NSW
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C07. National reforms to improve the health and medical research operating environment including National One Stop Shop (NOSS)
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C13. Updates on the implementation of the National Clinical Trials Governance Framework
12:15 PM - 1:30 PM Lunch (5th June)
12:45 PM - 1:30 PM D08. ARCS Careers Roadshow
1:30 PM - 2:30 PM C19. NSW Health Research and Innovation Strategy
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM C25a. QLD state update
C25b. Q&A panel Government Panel
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Closing Plenary - The Power of Little Brave Acts: Small Acts Leads to Big Changes
5:30 PM - 6:30 PM Closing Reception

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