Pharma and Device Forum™ 2026 Event Program
The program runs over two days and is designed to be easy to follow. Day 1 kicks off with everyone together in a plenary session in the Grand Ballroom. After lunch, the ballroom is divided into three breakout rooms – Brisbane, Sydney, and Perth where attendees can choose the sessions that best match their interests. Day 2 is fully stream‑based, with all sessions held in the Brisbane, Sydney, and Perth rooms.
Don’t forget to download the official event app Eventify to be able to view speakers, sponsors, program and to be able to interact with other attendees on the day. You will receive instructions at your time of registration on how to access.
Program (Day 1) – 16 March 2026
Use tabs below to view day 1 program
Session Title: Plenary
|
Time |
Speaker |
Presentation |
|---|---|---|
|
9:00 – 9:30 |
Jason Clarke, Cr. Andrew Rowse |
Opening & Welcome to the Forum |
|
9:30 – 10:00 |
Peter Tobin |
From first-in-human to value creation: Radiopharmaceuticals as a faster, lower-risk development platform |
|
10:00 – 10:30 |
Jason Clarke |
Beyond Compliance: Quality is a culture, not just a rulebook |
|
10:30 – 11:00 |
Morning Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: Plenary – International GMP Update & Trends (EU/US)
|
Time |
Speaker |
Presentation |
|---|---|---|
|
11:00 – 11:30 |
Gordon Farquharson |
Reflecting on the Past, Present & Future focusing on Contamination Control and Environmental Monitoring |
|
11:30 – 12:00 |
Vasiliki (Vee) Revithi |
European New Pharma Legislation: Global Harmonisation. |
|
12:00 – 12:30 |
Siôn Wyn |
GxP Computerised Systems: Annex 11 Revision and New Annex 22 – Enabling Innovation |
|
12:30 – 13:30 |
Lunch Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during your lunch break. |
Session Title: Regulatory Compliance & Culture (Leadership)
|
Time |
Speaker |
Presentation |
|---|---|---|
|
13:30 – 14:00 |
Ahsan Syed Ali |
Quality control, Quality Assurance, CAPA, Human error, and the human being |
|
14:00 – 14:30 |
Eric Miller |
Leadership as a System |
|
14:30 – 15:00 |
Jason Clarke |
Thinking Inside the Box: Innovation within a Regulated Environment |
|
15:00 – 15:30 |
Afternoon Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: Innovation – Research / Start Ups
|
Time |
Speaker |
Presentation |
|---|---|---|
|
15:30 – 16:00 |
Trevor Schoerie |
A 25-Year Reflection on Australian Pharmaceutical and Device Innovation |
|
16:00 – 16:30 |
Rosie Silk |
From Research to Revenue: Navigating R&D Incentives for Life Science Companies. |
|
16:30 – 19:00 |
Networking & |
Drinks and Nibbles – Professional Networking Session |
Session Title: Pharmaceutical Innovation – A&E Radiopharmaceuticals
|
Time |
Speaker |
Presentation |
|---|---|---|
|
13:30 – 14:00 |
Nic van der Nol |
Radiopharmaceutical Facility Design (Architecture) |
|
14:00 – 14:30 |
Dr John Young |
Radiopharmaceutical Facility Engineering |
|
14:30 – 15:00 |
Richard Hayne |
Practical Lessons from Transitioning into Radiopharmaceutical Operations |
|
15:00 – 15:30 |
Afternoon Tea Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: Sterile Manufacturing & Innovations
|
Time |
Speaker |
Presentation |
|---|---|---|
|
15:30 – 16:00 |
Ash Isbel |
Qualification of Cold Water Systems |
|
16:00 – 16:30 |
Robert Caunce |
An Australian API Story: Manufacture of an Active Pharmaceutical Ingredient in Australia for the treatment of Cancer around the world |
|
16:30 – 19:00 |
Networking/Drinks |
Drinks and Nibbles – Professional Networking Session |
Session Title: Innovation – Cleanroom & Laboratory Excellence, Plus Sustainability
|
Time |
Speaker |
Presentation |
|---|---|---|
|
13:30 – 14:00 |
Helen Evans-Lemmo |
Think Automation: Where Laboratory Compliance Meets Innovation |
|
14:00 – 14:30 |
Fabrizio Spada |
How to use Design of Experiment to Optimize Analytical Methods |
|
14:30 – 15:00 |
Micheal Schafferius |
Forever Plastics & Sustainability – Imagine not being able to use PVDF tomorrow |
|
15:00 – 15:30 |
Afternoon Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: Regulatory Governance Across the ARTG
|
Time |
Speaker |
Presentation |
|---|---|---|
|
15:30 – 16:00 |
Alison Davis |
Your name is on the ARTG: Understanding Sponsor Accountability |
|
16:00 – 16:30 |
Anne Saletti-Hayes |
Regulatory Pulse: What’s New for Medical Devices |
|
16:30 – 19:00 |
Networking/Drinks |
Networking & Drinks/Nibbles – Professional Networking Session |
Program (Day 2) – 17 March 2026
Use tabs below to view day 2 program
Session Title: AI / Regulatory Compliance
|
Time |
Speaker |
Presentation |
|---|---|---|
|
9:00 – 9:30 |
Vincent Garcia |
2026 Buyers’ Guide to Digital GxP Documentation: All Options Explained |
|
9:30 – 10:00 |
Siôn Wyn |
GxP Computerised Systems: GAMP Guidance Updates and Activities |
|
10:00 – 10:30 |
Susan Cheong |
Beyond Paper: Making Electronic Batch Records Work |
|
10:30 – 11:00 |
Morning Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: AI / Regulatory Compliance
|
Time |
Speaker |
Presentation |
|---|---|---|
|
11:00 – 11:30 |
Seamus Orr |
Embracing AI in the CQV Lifecycle |
|
11:30 – 12:00 |
Bass Masri |
The Next Frontier of Quality: Leveraging AI and Machine Learning to Increase Pharmaceutical Success |
|
12:00 – 12:30 |
Luke Armstrong |
The Promises and Perils of AI Agents in Quality: Agentic AI Applications in Pharmaceutical Quality. |
|
12:30 – 13:30 |
Lunch Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the lunch breaks. |
Session Title: AI / Regulatory Compliance
|
Time |
Speaker |
Presentation |
|---|---|---|
|
13:30 – 15:00 |
Matt Schoerie |
AI WORKSHOP – Operating AI Agents in GxP Quality: A QA Practitioner’s Guide (90 minutes) |
|
15:00 FINISH |
Forum Finishes |
The 2026 Pharma & Device Forum/GMP Forum finishes. |
Session Title: Cleanroom & Laboratory Excellence (STERILE Manufacturing)
|
Time |
Speaker |
Presentation |
|---|---|---|
|
9:00 – 9:30 |
Tara Cassidy |
Plasmid Manufacturing + QC and Process for mRNA Vaccines |
|
9:30 – 10:00 |
Richard Chai |
Sustainability Considerations in Manufacturing Process Cleaning |
|
10:00 – 10:30 |
Micheal Schafferius |
Single-Use System Testing: Leak testing of single use systems/components |
|
10:30 – 11:00 |
Morning Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: Cleanroom & Laboratory Excellence (STERILE Manufacturing)
|
Time |
Speaker |
Presentation |
|---|---|---|
|
11:00 – 11:30 |
Gordon Farquharson |
Update on ISO Cleanroom standards |
|
11:30 – 12:00 |
Dhanu Angga Kumara |
How Automation Can Facilitate Compliance with Annex 1, with a Focus on Final Filtration. |
|
12:00 – 12:30 |
Ian Henton-Smith |
Modern Isolation Technology for Sterility Testing: Regulatory Expectations, Risk Control and Operational Advantages |
|
12:30 – 13:30 |
Lunch Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the lunch breaks. |
Session Title: Validation Update
|
Time |
Speaker |
Presentation |
|---|---|---|
|
13:30 – 14:00 |
Ashley Isbel |
Annex 15 Validation Concept Paper – Discussion |
|
14:00 – 14:30 |
Shane Bourne |
Concepts for IMP Phase Appropriate Validation |
|
14:30 – 15:00 |
Luke Philp |
The Art/Science of the Validation Exception Report (VER). |
Session Title: Innovations – Medical Devices
|
Time |
Speaker |
Presentation |
|---|---|---|
|
9:00 – 9:30 |
Craig Neylon |
Building Medtech Innovation Ecosystems for Better Healthcare |
|
9:30 – 10:00 |
Tom Stray |
Failing and Scaling: Medical Device Manufacturing Success (Case Study) |
|
10:00 – 10:30 |
Paul Wynne |
Reinventing Oral Dose Form: From Manufacturing to Patient Experience |
|
10:30 – 11:00 |
Morning Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the breaks. |
Session Title: Innovations & Leadership/Thought Leaders – Pharma & Medical Devices
|
Time |
Speaker |
Presentation |
|---|---|---|
|
11:00 – 11:30 |
Paul Wynne |
Fundamental Learnings from A Non-Animal Apparatus for Investigating Longitudinal Absorption as an Alternative to USP Approaches |
|
11:30 – 12:00 |
Marlene |
Packaging Reform – Update APCO’s 2030 Strategy |
|
12:00 – 12:30 |
Aditi Bhasan |
Solving EM Challenges: with Innovative & Connected 3P® Solutions |
|
12:30 – 13:30 |
Lunch Break |
Please visit our amazing 2026 Pharma & Device Forum Sponsors during the lunch break. |
Session Title: Teams and Culture in Successful Regulated Businesses
|
Time |
Speaker |
Presentation |
|---|---|---|
|
13:30 – 14:00 |
Kathy Walsh |
Fix the Disconnect – How Integration and Culture Drive Business Performance |
|
14:00 – 14:30 |
Alan Doughty |
Building a Successful Business & Cohesive Team – 25 Years From Start up to Maturity (A Life Science Case Study) |
|
14:30 – 15:00 |
Jason Kavanagh |
Manufacturing Case Study |
2026 Pharma & Device Forum Program
The agenda & schedule for the 2026 Forum includes a Plenary on Monday morning, followed by 3 presentations of 30 minutes each across 3 different learning tracks (3 rooms), with plenty of time for networking during the morning and afternoon tea breaks plus an hour-long lunch break. The 2026 Forum is fully catered. When you register to attend, please note any specific dietary requirements on your registration form.
On Monday evening, there is also a networking event from 4.30 pm to 6.30 pm (our Platinum Sponsor this year is Telix Pharmaceuticals).
- This event will be held at the Sofitel on Collins, 25 Collins Place, Melbourne CBD, Australia, on 16th & 17th March 2026.
- This event is hosted by PharmOut (please follow us on LinkedIn) and its prestigious Industry Forum Sponsors.
- This information will also be available via the Event App (Eventify) for registered attendees.
Register now or send an enquiry through the ”Contact us’ page to ask about conference ticket pricing for 10 or more employees. Student discounts (PhD students and University-affiliated researchers) are available with a current University email address.
We look forward to seeing you in March 2026!
