The ARCS Pharmacovigilance (PV) Online Symposium is a new half-day interactive program designed to strengthen practical skills in pharmacovigilance. With organisations facing budget pressures and limited travel opportunities, this virtual afternoon format keeps learning accessible, affordable and easy to justify. The symposium focuses on real-world challenges, hands-on problem solving and inspection readiness.
Sessions are delivered in a workshop-style format with audience participation, practical exercises and case-based discussion. Each session is facilitated by sector experts and focuses on translating global insights into immediate local application.
Practical AI Tools for Pharmacovigilance: Working Smarter, Not Harder
Presenter: Carl Bufe, Director, BioSyn-AI
Artificial intelligence is increasingly being adopted across pharmacovigilance functions, yet many teams remain uncertain about how to use AI tools effectively, responsibly and in line with regulatory expectations. This practical session explores how tools such as ChatGPT, Microsoft Copilot and other AI-enabled platforms can be applied to everyday PV activities to improve efficiency and reduce administrative burden.
The session will demonstrate practical use cases relevant to pharmacovigilance teams, including supporting case processing activities, preparing for signal review, drafting documentation and streamlining workflows. Participants will learn how to develop effective prompts, understand the limitations of AI tools and apply appropriate professional judgement to ensure accuracy, data integrity and compliance.
Attendees will leave with actionable insights into how AI can be safely and pragmatically integrated into PV practice to support better outcomes without compromising quality or regulatory obligations.
Applying Human Factors to the Design of Risk Communication Tools and Materials
Presenter: Rabih Dabliz, Founder & CEO, AmanViva Medication Safety Services
Communication is often viewed as an art, but when it comes to medicines safety, it is also a science. This session examines how human factors principles can be applied to strengthen the design of Additional Risk Minimisation Measures (aRMMs), including patient booklets, alert cards, healthcare professional guides and digital tools developed as part of Risk Management Plans under TGA requirements.
Drawing on real examples from pharmacovigilance and frontline healthcare, the session will explore how information can be structured to be clear, intuitive and easy to navigate, how readability can be improved while reducing cognitive load, and how risk communication materials can be designed to genuinely support safer decisions and medicine use.
Participants will gain practical insights into creating risk communication tools that are grounded in human behaviour, aligned with regulatory expectations and designed to improve understanding and patient outcomes.
Global Lessons, Local Impact: Navigating PV Inspections in Australia
Presenter: Stephanie Martin, Managing Director, SMPV Ltd
Around the world, regulators continue to identify recurring pharmacovigilance inspection challenges, from documentation gaps to signal management issues. This session examines real findings from global regulators, explores why they matter and translates them into practical steps for Australian companies and partners. Attendees will gain actionable insights to improve inspection readiness and avoid costly compliance pitfalls.
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