Wednesday, June 12, 2024

GMP/Manufacturing
Reimbursement Policy
Prescription and Non-Prescription Medicine Regulation
Prescription Medicine Regulation
Medical Devices Regulation
Medical Operations
Leadership, Wellness and Resilience
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A02. Update from the Manufacturing Quality Branch A03. Convergence of technologies – drug, device, diagnostics – policy implications A04. TGO 91 compliance workshop A05. Getting the most out of repurposing medicines A06. QMSR (Quality Management Regulatory System) , ISO 13485, 14971 and EU MDR comparison A07. Navigating the Dynamic Landscape of Medical Information: Embracing AI and Enhancing Patient-centricity A08. Burnout and Building Resilience" -What's all the fuss? Management,Prevention and Recovery
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A09. GDP and GWP – what’s the difference? A10. Emergence of digital health – potential for healthcare and access challenges A11. TGO 92 compliance workshop A12. Medsafe updates A13. AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications A14. Medical Affairs capability building – unlocking the network of the future A15. 5 Simple Strategies for Success
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A16. Fundamentals of Digital Transformation A17. HTA review progress and where to from here? A18. Rare disease therapies: strategies and considerations in developing an orphan medicine A19. Crossing the Tasman: Insights into navigating the NZ regulatory terrain A20. Regulatory update from the Medical Devices Authorisations Branch (TGA) A21. The Rise of Patient Involvement and Value in the Evidence Lifecycle A22. Leading Change Intentionally
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A23. Recent developments in ICH Q series guidances and Quality Manturity A24. Patient centricity in HTA – towards greater transparency and accountability A25. Update from the Complementary and Over the Counter Medicines Branch at TGA A26. Vaping Reforms and Implementation A27. Impact of the European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape A28. From Review to Reality: How Feedback is Shaping the Medicines Australia Code 19 Review A29. Creative Communication: Leveraging Individual Attributes for Effective Collaboration
5:30 PM - 6:30 PM Welcome Reception
GMP/Manufacturing
Reimbursement Policy
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A02. Update from the Manufacturing Quality Branch A03. Convergence of technologies – drug, device, diagnostics – policy implications
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A09. GDP and GWP – what’s the difference? A10. Emergence of digital health – potential for healthcare and access challenges
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A16. Fundamentals of Digital Transformation A17. HTA review progress and where to from here?
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A23. Recent developments in ICH Q series guidances and Quality Manturity A24. Patient centricity in HTA – towards greater transparency and accountability
5:30 PM - 6:30 PM Welcome Reception

Prescription and Non-Prescription Medicine Regulation
Prescription Medicine Regulation
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A04. TGO 91 compliance workshop A05. Getting the most out of repurposing medicines
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A11. TGO 92 compliance workshop A12. Medsafe updates
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A18. Rare disease therapies: strategies and considerations in developing an orphan medicine A19. Crossing the Tasman: Insights into navigating the NZ regulatory terrain
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A25. Update from the Complementary and Over the Counter Medicines Branch at TGA A26. Vaping Reforms and Implementation
5:30 PM - 6:30 PM Welcome Reception

Medical Devices Regulation
Medical Operations
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A06. QMSR (Quality Management Regulatory System) , ISO 13485, 14971 and EU MDR comparison A07. Navigating the Dynamic Landscape of Medical Information: Embracing AI and Enhancing Patient-centricity
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A13. AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications A14. Medical Affairs capability building – unlocking the network of the future
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A20. Regulatory update from the Medical Devices Authorisations Branch (TGA) A21. The Rise of Patient Involvement and Value in the Evidence Lifecycle
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A27. Impact of the European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape A28. From Review to Reality: How Feedback is Shaping the Medicines Australia Code 19 Review
5:30 PM - 6:30 PM Welcome Reception

Leadership, Wellness and Resilience
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A08. Burnout and Building Resilience" -What's all the fuss? Management,Prevention and Recovery
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A15. 5 Simple Strategies for Success
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A22. Leading Change Intentionally
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A29. Creative Communication: Leveraging Individual Attributes for Effective Collaboration
5:30 PM - 6:30 PM Welcome Reception

GMP/Manufacturing
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A02. Update from the Manufacturing Quality Branch
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A09. GDP and GWP – what’s the difference?
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A16. Fundamentals of Digital Transformation
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A23. Recent developments in ICH Q series guidances and Quality Manturity
5:30 PM - 6:30 PM Welcome Reception

Reimbursement Policy
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A03. Convergence of technologies – drug, device, diagnostics – policy implications
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A10. Emergence of digital health – potential for healthcare and access challenges
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A17. HTA review progress and where to from here?
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A24. Patient centricity in HTA – towards greater transparency and accountability
5:30 PM - 6:30 PM Welcome Reception

Prescription and Non-Prescription Medicine Regulation
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A04. TGO 91 compliance workshop
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A11. TGO 92 compliance workshop
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A18. Rare disease therapies: strategies and considerations in developing an orphan medicine
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A25. Update from the Complementary and Over the Counter Medicines Branch at TGA
5:30 PM - 6:30 PM Welcome Reception

Prescription Medicine Regulation
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A05. Getting the most out of repurposing medicines
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A12. Medsafe updates
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A19. Crossing the Tasman: Insights into navigating the NZ regulatory terrain
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A26. Vaping Reforms and Implementation
5:30 PM - 6:30 PM Welcome Reception

Medical Devices Regulation
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A06. QMSR (Quality Management Regulatory System) , ISO 13485, 14971 and EU MDR comparison
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A13. AI/ML in Medical Devices – Demystifying Global Requirements for premarket applications
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A20. Regulatory update from the Medical Devices Authorisations Branch (TGA)
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A27. Impact of the European Medical Device Directive to Medical Device Regulations transition on the Australian regulatory landscape
5:30 PM - 6:30 PM Welcome Reception

Medical Operations
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A07. Navigating the Dynamic Landscape of Medical Information: Embracing AI and Enhancing Patient-centricity
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A14. Medical Affairs capability building – unlocking the network of the future
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A21. The Rise of Patient Involvement and Value in the Evidence Lifecycle
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A28. From Review to Reality: How Feedback is Shaping the Medicines Australia Code 19 Review
5:30 PM - 6:30 PM Welcome Reception

Leadership, Wellness and Resilience
8:45 AM - 9:30 AM A01a. Fuelling Advancements in DIPG Research and Treatment: The Journey of a Scientist-Parent
9:30 AM - 10:30 AM A01b. The future of approval and access: The confluence of consumer collaborations and leadership competencies
10:30 AM - 11:15 AM Morning Tea (12 June)
11:15 AM - 12:15 PM A08. Burnout and Building Resilience" -What's all the fuss? Management,Prevention and Recovery
12:15 PM - 1:30 PM Lunch (12 June)
1:30 PM - 2:30 PM A15. 5 Simple Strategies for Success
2:30 PM - 2:45 PM
Session change (12 June)
2:45 PM - 3:45 PM A22. Leading Change Intentionally
3:45 PM - 4:30 PM Afternoon Tea (12 June)
4:30 PM - 5:30 PM A29. Creative Communication: Leveraging Individual Attributes for Effective Collaboration
5:30 PM - 6:30 PM Welcome Reception

Thursday, June 13, 2024

Clinical Research Landscape
Clinical Research
Prescription Medicines and Devices Regulation
Prescription Medicines Regulation
Reimbursement
Data, Technology and Informatics
Pharmacovigilance
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B02. Update on Establishing the National One Stop Shop for Clinical Trials B03. The Privacy Act in Australia: A summary of your obligations and reporting requirements B04. Regulatory update from the Medical Devices Surveillance Branch B05. Navigating the Future: Regulatory insights and innovations in advanced therapeutics B06. The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement in the U.S. market, not rest and relaxation) B07. Revolutionising pharmaceutical regulatory efficiency: Harnessing the power of AI and LLM B08. RMP and RMMs - it takes a village
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B09. TGA Clinical Trial Landscape Updates B10. The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form B11. Global Market Strategies: Utilising International Evidence and Navigating Regional Regulations for Medical Devices B12. Challenges of regulatory and logistics for bringing cell therapies to Australia B13. Navigating the Australian Medical Technologies Reimbursement and Funding Landscape B14. Transformative Technologies: Risk-Based AI Frameworks and Agile Intelligence in Healthcare Data B15. Update from the TGA Pharmacovigilance Branch
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B16. NSW Health and Queensland Health sector updates B17. Complex Clinical Trials. Design, participation, conduct and HREC review - Part II B18. Prescription Medicine Authorisation Branch annual update B19. CMC variations: Navigating the greyzones B20. Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there? B21. Coalition of the willing - change management in solution implementation B22. Unapproved medicines and PV (Clinical and SAS)
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B23. Clinical trial sites perspectives on common challenges and practical solutions B24. Flexible approach to OGTR licences issued for the delivery of Gene therapy: one licence, multiple therapies B25. How to make sense of RNA-based therapeutics B26. Nitrosamine Impurities in Medicine - A Hot Topic B27. Horizon scanning - learnings from the past and defining a purpose and pathway for the future B28. What have we learnt and what to expect? B29. AI in PV
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience
Clinical Research Landscape
Clinical Research
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B02. Update on Establishing the National One Stop Shop for Clinical Trials B03. The Privacy Act in Australia: A summary of your obligations and reporting requirements
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B09. TGA Clinical Trial Landscape Updates B10. The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B16. NSW Health and Queensland Health sector updates B17. Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B23. Clinical trial sites perspectives on common challenges and practical solutions B24. Flexible approach to OGTR licences issued for the delivery of Gene therapy: one licence, multiple therapies
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Prescription Medicines and Devices Regulation
Prescription Medicines Regulation
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B04. Regulatory update from the Medical Devices Surveillance Branch B05. Navigating the Future: Regulatory insights and innovations in advanced therapeutics
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B11. Global Market Strategies: Utilising International Evidence and Navigating Regional Regulations for Medical Devices B12. Challenges of regulatory and logistics for bringing cell therapies to Australia
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B18. Prescription Medicine Authorisation Branch annual update B19. CMC variations: Navigating the greyzones
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B25. How to make sense of RNA-based therapeutics B26. Nitrosamine Impurities in Medicine - A Hot Topic
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Reimbursement
Data, Technology and Informatics
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B06. The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement in the U.S. market, not rest and relaxation) B07. Revolutionising pharmaceutical regulatory efficiency: Harnessing the power of AI and LLM
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B13. Navigating the Australian Medical Technologies Reimbursement and Funding Landscape B14. Transformative Technologies: Risk-Based AI Frameworks and Agile Intelligence in Healthcare Data
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B20. Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there? B21. Coalition of the willing - change management in solution implementation
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B27. Horizon scanning - learnings from the past and defining a purpose and pathway for the future B28. What have we learnt and what to expect?
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Pharmacovigilance
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B08. RMP and RMMs - it takes a village
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B15. Update from the TGA Pharmacovigilance Branch
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B22. Unapproved medicines and PV (Clinical and SAS)
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B29. AI in PV
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Clinical Research Landscape
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B02. Update on Establishing the National One Stop Shop for Clinical Trials
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B09. TGA Clinical Trial Landscape Updates
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B16. NSW Health and Queensland Health sector updates
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B23. Clinical trial sites perspectives on common challenges and practical solutions
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Clinical Research
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B03. The Privacy Act in Australia: A summary of your obligations and reporting requirements
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B10. The CT:IQ InFORMed Project: Update on Implementing a redesigned Participant Information and Consent Form
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B17. Complex Clinical Trials. Design, participation, conduct and HREC review - Part II
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B24. Flexible approach to OGTR licences issued for the delivery of Gene therapy: one licence, multiple therapies
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Prescription Medicines and Devices Regulation
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B04. Regulatory update from the Medical Devices Surveillance Branch
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B11. Global Market Strategies: Utilising International Evidence and Navigating Regional Regulations for Medical Devices
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B18. Prescription Medicine Authorisation Branch annual update
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B25. How to make sense of RNA-based therapeutics
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Prescription Medicines Regulation
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B05. Navigating the Future: Regulatory insights and innovations in advanced therapeutics
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B12. Challenges of regulatory and logistics for bringing cell therapies to Australia
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B19. CMC variations: Navigating the greyzones
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B26. Nitrosamine Impurities in Medicine - A Hot Topic
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Reimbursement
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B06. The ABC's of R&R (Spoiler alert: we are talking Regulatory and reimbursement in the U.S. market, not rest and relaxation)
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B13. Navigating the Australian Medical Technologies Reimbursement and Funding Landscape
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B20. Sector readiness/preparedness for delivering cell and gene therapies - why aren't we there?
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B27. Horizon scanning - learnings from the past and defining a purpose and pathway for the future
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Data, Technology and Informatics
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B07. Revolutionising pharmaceutical regulatory efficiency: Harnessing the power of AI and LLM
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B14. Transformative Technologies: Risk-Based AI Frameworks and Agile Intelligence in Healthcare Data
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B21. Coalition of the willing - change management in solution implementation
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B28. What have we learnt and what to expect?
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Pharmacovigilance
8:45 AM - 10:30 AM B01. Pandora's black box - ethical and legal implications of AI in healthcare
10:30 AM - 11:15 AM Morning Tea (13 June)
10:40 AM - 11:10 AM D04. ARCS Competency Framework Q & A Session
11:15 AM - 12:15 PM B08. RMP and RMMs - it takes a village
12:15 PM - 1:30 PM Lunch (13 June)
12:45 PM - 1:15 PM D05. Simplifying Safety Letter Distribution through Technology
Sponsored by Veeva Australia
1:30 PM - 2:30 PM B15. Update from the TGA Pharmacovigilance Branch
2:30 PM - 2:45 PM
Session change (13 June)
2:45 PM - 3:45 PM B22. Unapproved medicines and PV (Clinical and SAS)
3:45 PM - 4:30 PM Afternoon Tea (13 June)
4:30 PM - 5:30 PM B29. AI in PV
5:30 PM - 6:30 PM Networking Function
6:30 PM - 10:00 PM
Conference dinner and Vivid cruise experience

Friday, June 14, 2024

Clinical Research
Diversity, Inclusiveness and Consumer Engagement
Clinical Workforce and Capacity
BioBeacon
Innovation/General Interest
Leadership, Wellness and Resilience
Careers and the MTP Sector
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C02. How to promote confidence in clinical trials, and undo misinformation, in your social circles & communities C03. A site and sponsor -facing Caregiver Advisory Board: a forward-thinking approach to early protocol development and feasibility C04. Unlocking Potential: Exploring the Clinical Trials Workforce and Research Grant Impact BB01. BioBeacon: ARIA Research, Roam Technologies and dermRhealth C06. Gene and Cell Therapy: Running efficient Clinical Trials with Multi-Disciplinary teams C07. The Secrets of Maximising Your Potential S1. Careers in the MTP sector - Overview of the sector and stakeholder
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C09. Safety Reporting and Clinical Incidents - What to Report and Why C10. Diversity in clinical research C11. Building Strong Clinical Trial Teams: Enhancing Efficiency and Cohesion BB02. BioBeacon: Zymedyne Therapeutics, Culturon and Ab Initio Pharma C13. Capacity building on early phase challenge trials (infectious diseases case study – malaria research) C14. Elevate Your Leadership: Unlock Your "Leadership Why" To Propel Your Influence & Impact S2. Careers in the MTP sector - Spotlight on the clinical research landscape
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C16. Innovations in recruiting participants C17. What patients and their families need from clinical trials C18. Stories from the Summit: Harnessing the National Clinical Trials Governance Framework to deliver Health Service Safety, Quality, Culture, Capacity to the Community BB03. BioBeacon: iiShield, Eudaemon Technologies and NGB Innovation C20. Revolutionizing Clinical Trials: Innovation in approval processes and trial design C21. Creating a Compelling Ambition S3. Careers in the MTP sector - Spotlight on regulatory and pharmacovigilance
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C23. Meeting the National Clinical Trials Governance Framework's expectations for patient engagement and partnering C24. Community Involvement in Clinical Trials C25. Australian Teletrial Program (ATP) - Sector updates C27. Being inspection ready in a digital clinical trial space C28. Building Flow into Your Work S4. Careers in the MTP sector - Medical Affairs, MI and Reimbursement
5:30 PM - 6:30 PM Closing Reception
Clinical Research
Diversity, Inclusiveness and Consumer Engagement
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C02. How to promote confidence in clinical trials, and undo misinformation, in your social circles & communities C03. A site and sponsor -facing Caregiver Advisory Board: a forward-thinking approach to early protocol development and feasibility
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C09. Safety Reporting and Clinical Incidents - What to Report and Why C10. Diversity in clinical research
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C16. Innovations in recruiting participants C17. What patients and their families need from clinical trials
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C23. Meeting the National Clinical Trials Governance Framework's expectations for patient engagement and partnering C24. Community Involvement in Clinical Trials
5:30 PM - 6:30 PM Closing Reception

Clinical Workforce and Capacity
BioBeacon
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C04. Unlocking Potential: Exploring the Clinical Trials Workforce and Research Grant Impact BB01. BioBeacon: ARIA Research, Roam Technologies and dermRhealth
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C11. Building Strong Clinical Trial Teams: Enhancing Efficiency and Cohesion BB02. BioBeacon: Zymedyne Therapeutics, Culturon and Ab Initio Pharma
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C18. Stories from the Summit: Harnessing the National Clinical Trials Governance Framework to deliver Health Service Safety, Quality, Culture, Capacity to the Community BB03. BioBeacon: iiShield, Eudaemon Technologies and NGB Innovation
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C25. Australian Teletrial Program (ATP) - Sector updates
5:30 PM - 6:30 PM Closing Reception

Innovation/General Interest
Leadership, Wellness and Resilience
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C06. Gene and Cell Therapy: Running efficient Clinical Trials with Multi-Disciplinary teams C07. The Secrets of Maximising Your Potential
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C13. Capacity building on early phase challenge trials (infectious diseases case study – malaria research) C14. Elevate Your Leadership: Unlock Your "Leadership Why" To Propel Your Influence & Impact
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C20. Revolutionizing Clinical Trials: Innovation in approval processes and trial design C21. Creating a Compelling Ambition
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C27. Being inspection ready in a digital clinical trial space C28. Building Flow into Your Work
5:30 PM - 6:30 PM Closing Reception

Careers and the MTP Sector
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM S1. Careers in the MTP sector - Overview of the sector and stakeholder
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM S2. Careers in the MTP sector - Spotlight on the clinical research landscape
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM S3. Careers in the MTP sector - Spotlight on regulatory and pharmacovigilance
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM S4. Careers in the MTP sector - Medical Affairs, MI and Reimbursement
5:30 PM - 6:30 PM Closing Reception

Clinical Research
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C02. How to promote confidence in clinical trials, and undo misinformation, in your social circles & communities
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C09. Safety Reporting and Clinical Incidents - What to Report and Why
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C16. Innovations in recruiting participants
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C23. Meeting the National Clinical Trials Governance Framework's expectations for patient engagement and partnering
5:30 PM - 6:30 PM Closing Reception

Diversity, Inclusiveness and Consumer Engagement
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C03. A site and sponsor -facing Caregiver Advisory Board: a forward-thinking approach to early protocol development and feasibility
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C10. Diversity in clinical research
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C17. What patients and their families need from clinical trials
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C24. Community Involvement in Clinical Trials
5:30 PM - 6:30 PM Closing Reception

Clinical Workforce and Capacity
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C04. Unlocking Potential: Exploring the Clinical Trials Workforce and Research Grant Impact
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C11. Building Strong Clinical Trial Teams: Enhancing Efficiency and Cohesion
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C18. Stories from the Summit: Harnessing the National Clinical Trials Governance Framework to deliver Health Service Safety, Quality, Culture, Capacity to the Community
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C25. Australian Teletrial Program (ATP) - Sector updates
5:30 PM - 6:30 PM Closing Reception

BioBeacon
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM BB01. BioBeacon: ARIA Research, Roam Technologies and dermRhealth
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM BB02. BioBeacon: Zymedyne Therapeutics, Culturon and Ab Initio Pharma
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM BB03. BioBeacon: iiShield, Eudaemon Technologies and NGB Innovation
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM
5:30 PM - 6:30 PM Closing Reception

Innovation/General Interest
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C06. Gene and Cell Therapy: Running efficient Clinical Trials with Multi-Disciplinary teams
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C13. Capacity building on early phase challenge trials (infectious diseases case study – malaria research)
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C20. Revolutionizing Clinical Trials: Innovation in approval processes and trial design
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C27. Being inspection ready in a digital clinical trial space
5:30 PM - 6:30 PM Closing Reception

Leadership, Wellness and Resilience
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM C07. The Secrets of Maximising Your Potential
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM C14. Elevate Your Leadership: Unlock Your "Leadership Why" To Propel Your Influence & Impact
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM C21. Creating a Compelling Ambition
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM C28. Building Flow into Your Work
5:30 PM - 6:30 PM Closing Reception

Careers and the MTP Sector
8:45 AM - 9:30 AM C01a. From Discovery to FDA Approval: The 30-Year Odyssey, an Australian Biomedical Triumph
9:30 AM - 10:30 AM C01b. Gene and Cell Therapy: Leading change through translation pathways
10:30 AM - 11:15 AM Morning Tea (14 June)
11:15 AM - 12:15 PM S1. Careers in the MTP sector - Overview of the sector and stakeholder
12:15 PM - 1:30 PM Lunch (14 June)
12:45 PM - 1:15 PM D08. On the frontline of Ramsay Research: Learnings from the Clinical Trials Sites
Sponsored by Ramsay Research
1:30 PM - 2:30 PM S2. Careers in the MTP sector - Spotlight on the clinical research landscape
2:30 PM - 2:45 PM
Session change (14 June)
2:45 PM - 3:45 PM S3. Careers in the MTP sector - Spotlight on regulatory and pharmacovigilance
3:45 PM - 4:30 PM Afternoon Tea (14 June)
4:30 PM - 5:30 PM S4. Careers in the MTP sector - Medical Affairs, MI and Reimbursement
5:30 PM - 6:30 PM Closing Reception

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