Speakers 2026
Aditi Bhasin
Marketing Manager- Pharma Quality Control
bioMérieux
Presentation: Solving EM Challenges: with Innovative & Connected 3P® Solutions
Ahsan Syed Ali
Director of Quality and CMC Regulatory, QBiotics
Managing Director, Aphex Pharma Solutions
Presentation: Quality control, Quality Assurance, CAPA, Human error, and the human being 🙂
Cr. Andrew Rowse
Councilor, City of Melbourne
Presentation: Industry Update – Life Science Business Development
Alan Doughty
Chemika
Presentation: Building a Successful Business & Cohesive Team – 25 Years From Start up to Maturity (A Life Science Case Study)
Alison Davis
Quality and Regulatory Affairs Director, PharmOut
Presentation: Your Name is on the ARTG: Understanding Sponsor Accountability
Anne Saletti-Hayes
Presentation: Regulatory Pulse: What’s New for Medical Devices
Ashley Isbel
Presentation 1: Qualification of Cold Water Systems
Presentation 2: Annex 15 Concept Paper Discussion
Bass Masri
Presentation: The Next Frontier of Quality: Leveraging AI and Machine Learning to Increase Pharmaceutical Success
Craig Neylon
Presentation: Building MedTech Innovation Ecosystems for Better Healthcare
Dhanu Angga Kumara
Project Manager & Application Specialist (South-East Asia, Taiwan, Oceania), Merck
Presentation: How Automation Can Facilitate Compliance with Annex 1, with a Focus on Final Filtration
Eleanor Redding
Presentation: AI WORKSHOP – Operating AI Agents in GxP Quality: A QA Practitioner’s Guide
Eric Miller
Presentation: Leadership as a System
Fabrizio Spada, PhD, GAICD
Presentation: Optimizing Analytical Methods Using Design of Experiments
Gordon Farquharson
Plenary: Reflecting on the Past, Present & Future focusing on Contamination Control and Environmental Monitoring
Presentation (Day 2): Update on ISO Cleanroom standards
Helen Evans-Lemmo
Presentation: Think Automation: Where Laboratory Compliance Meets Innovation
Ian Henton-Smith
Presentation: Modern Isolation Technology for Sterility Testing: Regulatory Expectations, Risk Control and Operational Advantages
Jason Clarke
Presentation (Plenary): Beyond Compliance: Quality is a culture, not just a rulebook
Presentation (Day 1): Thinking Inside the Box: Innovation within a Regulated Environment
Dr John Young
Presentation: Radiopharmaceutical Facility Engineering
Luke Armstrong
Presentation: The Promises and Perils of AI Agents in Quality:
Agentic AI Applications in Pharmaceutical Quality.
Luke Philp
Presentation: The Art/Science of the Validation Exception Report (VER)
Kathy Walsh
Presentation: Fix the Disconnect – How Integration and Culture Drive Business Performance
in Regulated Industries
Maria Mylonas
Chair of the Leadership Session
Marlene Cronje-Vermeulen
Australian Packaging Covenant Organisation (APCO)
Presentation: Update on Sustainable Packaging (APCO Strategy)
Matthew Schoerie
Special Workshop (Day 2): Operating AI Agents in GxP Quality: A QA Practitioner’s Guide
Micheal Schafferius
Presentation: Forever plastics & sustainability.
Presentation: Single-Use System Testing – Leak testing of single use systems/components
Nic van der Nol
Presentation: Radiopharmaceutical Facility Architecture/Design
Paul Wynne
Presentation: Fundamental Learnings from A Non-Animal Apparatus For Investigating Longitudinal Absorption as an Alternative to USP Approaches
Presentation: Reinventing the Oral Dose Form from Manufacturing to Patient Experience
Peter Tobin
Presentation: From first-in-human to value creation: radiopharmaceuticals as a faster, lower-risk development platform.
Richard Chai
Presentation: Sustainability Considerations in Manufacturing Process Cleaning (Utilities Saving)
Richard Hayne
Presentation: Practical Lessons from Transitioning into Radiopharmaceutical Operations
Robert Caunce
Quality Director, IDT
Presentation: An Australian API Story: Manufacture of an Active Pharmaceutical Ingredient in Australia for the treatment of Cancer around the world.
Rosie Silk
Presentation: From Research to Revenue: Navigating R&D Incentives for Life Science Companies.
Seamus Orr
Presentation:
Embracing AI in the CQV Lifecycle
Shane Bourne
Presentation: Concepts for IMP Phase-Appropriate Validation
Siôn Wyn
Presentation (Plenary): GxP Computerised Systems: Annex 11 Revision and New Annex 22 – Enabling Innovation
Presentation (Day 2): GxP Computerised Systems: GAMP Guidance Updates and Activities
Susan Cheong
Presentation: Challenges of Transitioning to Electronic Batch Record Systems from Paper
Tom Stray
Presentation: Failing and Scaling (Medical Device Manufacturing Success – Case Study)
Tara Cassidy
Applications Development Specialist II,
Charles River Laboratories (CRL)
Presentation: Plasmid manufacturing + qc and process for mRNA vaccines
Trevor Schoerie
Presentation: The Most Innovative Initiatives over 20 Years of Observing the Industry
Vasiliki (Vee) Revithi
Presentation (Plenary):
European New Pharma Legislation: Global Harmonisation.
Contributors – ICMRA – PIC/S
And where is PIC/S heading?
Vicenç Garcia (Vincent)
Presentation (Day 2):
2026 Buyers’ Guide to Digital GxP Documentation: All Options Explained
Presentation: Workshop (Day 2): Operating AI Agents in GxP Quality: A QA Practitioner’s Guide (Co-presenting with Matt Schoerie and Eleanor Redding)
