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. VIC State Update 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 A09a. 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
A09b. Chair perspective
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A14a. Clinical Trial manufacture and Phase Appropriate Quality 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. Med Ops Think Tank A19. Leadership Excellence in Regulatory Affairs: Advancing Action Logics and Leadership Influence
A14b. Compliance, Quality Maturity and the CDMO: Navigating Challenges in a Multi-Stakeholder Environment
3:45 PM - 4:30 PM
Afternoon Tea (3rd June)
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. Medicines code of conduct update 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 A09a. HTA Reform
A09b. Chair perspective
2:30 PM - 2:45 PM
Session Change-over (3rd June)
2:45 PM - 3:45 PM A14a. Clinical Trial manufacture and Phase Appropriate Quality A15. Prescribed List Assessment Processes: An Evaluation
A14b. Compliance, Quality Maturity and the CDMO: Navigating Challenges in a Multi-Stakeholder Environment
3:45 PM - 4:30 PM
Afternoon Tea (3rd June)
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. VIC State Update 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)
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. Med Ops Think Tank A19. Leadership Excellence in Regulatory Affairs: Advancing Action Logics and Leadership Influence
3:45 PM - 4:30 PM
Afternoon Tea (3rd June)
4:30 PM - 5:30 PM A24. Medicines code of conduct update 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. Clinical Trial manufacture and Phase Appropriate Quality
A14b. Compliance, Quality Maturity and the CDMO: Navigating Challenges in a Multi-Stakeholder Environment
3:45 PM - 4:30 PM
Afternoon Tea (3rd June)
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 A09a. HTA Reform
A09b. Chair perspective
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)
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. VIC State Update
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)
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)
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. Med Ops Think Tank
3:45 PM - 4:30 PM
Afternoon Tea (3rd June)
4:30 PM - 5:30 PM A24. Medicines code of conduct update
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: Advancing Action Logics and Leadership Influence
3:45 PM - 4:30 PM
Afternoon Tea (3rd June)
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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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. Evolution of field market access role, new engagement models and real-world success stories in modern market access execution
12:15 PM - 1:30 PM Lunch (4th June)
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. Harmonisation, compliance and convergence 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. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks B19a. Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
B15b. ICH GCP R3: Changes, Flexibility and Challenges B18b. A Journey of Real World Data Supporting Improved Cancer Care and Research Opportunities 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. Clin-Reg considerations when conducting 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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
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. Clin-Reg considerations when conducting 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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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. Evolution of field market access role, new engagement models and real-world success stories in modern market access execution
12:15 PM - 1:30 PM Lunch (4th June)
1:30 PM - 2:30 PM B10. Harmonisation, compliance and convergence 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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
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. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks B19a. Navigating the pharmacovigilance requirements of listed and complementary medicines in the Australian regulatory environment
B18b. A Journey of Real World Data Supporting Improved Cancer Care and Research Opportunities 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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
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. Clin-Reg considerations when conducting 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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
1:30 PM - 2:30 PM B10. Harmonisation, compliance and convergence
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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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. Evolution of field market access role, new engagement models and real-world success stories in modern market access execution
12:15 PM - 1:30 PM Lunch (4th June)
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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
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. Clinical Research Data Sharing: Towards Clear and Consistent Governance Frameworks
B18b. A Journey of Real World Data Supporting Improved Cancer Care and Research Opportunities
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. Panel with CEOs of peak bodies - What the sector looks like in 5-10years time
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)
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
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
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 C07a. National reforms to improve the health and medical research operating environment
C07b. 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
C11. Precision Medicine- the transformative power of education on delivering on innovation
C12. QPPV Forum
C13a. Review of the National Standard Operating Procedures for Clinical Trials in Australia
C09b. Variances, Complexities and Individualised Care in CRPS- C13b. Updates on the implementation of the National Clinical Trials Governance Framework
12:15 PM - 1:30 PM Lunch (5th June)
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
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
C19a. Investment NSW - International Opportunities
C14b. Global Accreditation Standards and Australia’s First Certified Clinical Research Site Network C19b. NSW Health Research and Innovation Strategy
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
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception
Clinical Research
Diversity, Inclusiveness and Consumer Engagement
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)
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

BioBeacon Drug Discovery Forum
General Interest
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
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
C11. Precision Medicine- the transformative power of education on delivering on innovation
12:15 PM - 1:30 PM Lunch (5th June)
1:30 PM - 2:30 PM
C16. NSW early drug discovery forum
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
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

Leadership, Wellness & Resilience
Government Updates
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 C07a. National reforms to improve the health and medical research operating environment
C07b. National One Stop Shop (NOSS)
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM
C12. QPPV Forum
C13a. Review of the National Standard Operating Procedures for Clinical Trials in Australia
C13b. Updates on the implementation of the National Clinical Trials Governance Framework
12:15 PM - 1:30 PM Lunch (5th June)
1:30 PM - 2:30 PM C18. Confident Conversations: Turn Difficult Discussions Into Your Superpower
C19a. Investment NSW - International Opportunities
C19b. 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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

Clinical Research
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)
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

Diversity, Inclusiveness and Consumer Engagement
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)
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

BioBeacon Drug Discovery Forum
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
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM
C10. NSW early drug discovery forum
12:15 PM - 1:30 PM Lunch (5th June)
1:30 PM - 2:30 PM
C16. NSW early drug discovery forum
2:30 PM - 2:45 PM Session Change-over (5th June)
2:45 PM - 3:45 PM
C22. NSW early drug discovery forum
3:45 PM - 4:30 PM Afternoon Tea (5th June)
4:30 PM - 5:30 PM C26. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

General Interest
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)
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

Leadership, Wellness & Resilience
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. QPPV Forum
12:15 PM - 1:30 PM Lunch (5th June)
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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

Government Updates
9:00 AM - 9:30 AM C01. The Mesoblast Bench to Bedside Journey
9:30 AM - 10:30 AM C07a. National reforms to improve the health and medical research operating environment
C07b. National One Stop Shop (NOSS)
10:30 AM - 11:15 AM Morning Tea (5th June)
11:15 AM - 12:15 PM C13a. Review of the National Standard Operating Procedures for Clinical Trials in Australia
C13b. Updates on the implementation of the National Clinical Trials Governance Framework
12:15 PM - 1:30 PM Lunch (5th June)
1:30 PM - 2:30 PM
C19a. Investment NSW - International Opportunities
C19b. 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. Plenary Keynote - Sam Cawthorn
5:30 PM - 6:30 PM Closing Reception

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