VIRTUAL WORKSHOP
Future-Proof Your SOPs: How to use AI, ICH E6 (R3) updates
“This is a very informative workshop that helps make SOP development an achievable task, not a daunting task. Great for site coordinators and investigators.”- Margaret-Ann Tait, Research Manager, University of Sydney
“This workshop was extremely engaging and practical. It helped me to vastly improve our training and implementation of SOPs on site. ” – Kim Clark, Clinical Trial Coordinator, NSW
“I recommend this workshop to anyone who is involved in clinical trials. This workshop really helps you to understand SOPs and how to use these effectively. Real world examples and practical tools given are very practical.” – Narges Janalizadeh, Clinical Trial Coordinator, Northeast Health Wangaratta
Standard Operating Procedures (SOPs) are foundational to the success and integrity of every clinical trial. However, they are often underutilised, overly complex, or out of date. This virtual workshop, Future-Proof Your SOPs: How to use AI, ICH E6 (R3) updates, and new skills you need now will give you the knowledge and practical tools to develop SOPs that are clear, compliant, and fit for purpose. Enhanced with insights into emerging AI applications and aligned with the forthcoming ICH E6 (R3) updates.
You can claim 4 CPD points from this workshop.
What’s New in This Workshop?
- Explore how AI is changing SOPs
Learn how AI is influencing document creation, risk management, and compliance. We’ll show you how to prepare your SOPs for integration with AI tools without losing the human oversight that matters most.
- Get ready for ICH E6 (R3)
The new R3 updates are reshaping trial conduct, risk-based quality management, and sponsor-investigator responsibilities. We break it down and show you how to adapt your SOPs for upcoming regulatory shifts.
Who Should Attend:
This updated workshop is ideal for professionals who need to stay ahead of SOP evolution, including:
- Clinical Trial Managers & Coordinators
- QA, Regulatory & Compliance Specialists
- Governance & Ethics Administrators
- SOP Writers & Document Owners
- CRO & Sponsor Staff involved in site oversight
What You’ll Learn
- How to design SOPs that meet current and emerging regulatory expectations
- Writing for clarity, usability, and audit-readiness
- Integrating AI tools (like document generation, audit tracking, and change logs) to vastly improve SOPs
- Applying risk-based thinking aligned with ICH E6 (R3) principles
- Avoiding common SOP mistakes (overwriting, ambiguity, over-reliance on templates)
- Building flexibility into SOPs for a dynamic research landscape
Our training and education offers have been developed according to Australian and international best practice standards.
Our modules are built upon the competencies developed by the Harvard Multi-Regional Trials Centre (MRCT) and aligned to competencies recommended by the NHMRC.
These training offers are regarded as a benchmark for researchers, clinical trials, and healthcare professionals in Australia and internationally.
About the Facilitator
Sarah Piplica
Sarah is the Regulatory, Startup and Patient Partnerships Manager at University of the Sunshine Coast (UniSC) Clinical Trials Centre in Queensland. In her role, Sarah provides high level strategic advice and guidance in the overall management and compliance of extensive and complex ethics and regulatory processes, maintaining quality standards and monitoring and audit readiness.
In 2019, Sarah was awarded the Osmond Russell Scholarship from ARCS, for a project that is seeing her research and validate a patient co-authored survey to solicit regular and meaningful feedback from clinical trials participants. Sarah is passionate about advocating for patient, participant and carer involvement within the medicines development industries.
Price
Price: $599 +GST pp
PRAXIS Partner price: $479 +GST pp
*Savings available for group enrolments and for PRAXIS partner organisations.
Next Virtual Workshop
Thursday 5 March 2026: 10.00am – 2.00pm (Sydney Time) Filling Fast
Wednesday 6 May 2026: 10.00am – 2.00pm (Sydney Time)
Thursday 13 August 2026: 10.00am – 2.00pm (Sydney Time)
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