Symposium 6: Next-generation vaccine pharmacovigilance: real-world evidence, AI and global collaboration
Tracks
Track 3
| Saturday, October 31, 2026 |
| 15:30 - 17:00 |
| Lecture Theatre 5 |
Details
Traditional pharmacovigilance systems are increasingly challenged by the speed, scale and complexity of modern vaccine deployment, with timely evidence generation and public confidence critical during both routine immunisation programmes and public health emergencies. Emerging approaches that integrate population data, digital epidemiology, AI-enabled intelligence and collaborative global surveillance networks are redefining how vaccine safety signals can be detected, investigated and interpreted in near real time. Our expert team will lead a journey through practical delivery of next-gen real-world evidence in the context of ever-increasing demand for rapid, transparent and responsive vaccine pharmacovigilance.
Why real-world evidence matters in vaccine pharmacovigilance: Hazel Clothier — Experienced vaccine safety epidemiologist leading vaccine vigilance programs across Australia and multinational collaborations — will introduce how traditional pharmacovigilance approaches are increasingly challenged by the complexity of modern vaccine deployment, and why integrated real-world evidence approaches are needed to reshape contemporary vaccine vigilance.
1. Vaccine safety signal investigation in practice: An end-to-end case study: Daneeta Hennessy — Operational vaccine safety investigator with expertise translating emerging safety signals into evidence-based public health assessment and communication — will provide a practical walkthrough of an end-to-end vaccine safety investigation, demonstrating how a potential safety concern was identified, assessed and interpreted through the integration of complementary surveillance systems and epidemiological methods.
2. The highs & lows of using large-linked data systems: John Mallard — Early career researcher with practical expertise in large, linked data analyses for vaccine safety evaluation — will demonstrate how population-wide linked datasets enable powerful post-licensure vaccine safety analyses and investigations following new vaccine introductions, while also highlighting the practical challenges and considerations required when using real-world linked-data for surveillance.
3. From community concern to evidence: The role of primary care data: Aishwarya Shetty — Emerging pharmacoepidemiologist specialising in use of primary healthcare datasets — will examine the growing role of primary care data in vaccine pharmacovigilance, using a case study to highlight how these data can sometimes be the only source able to answer emerging safety concerns, capture syndromic surveillance patterns, and strengthen transparent, evidence-based responses to community concerns.
4. AI-enabled infodemic surveillance and vaccine safety intelligence: Gerardo Luis Dimaguila — Health informatician and AI researcher— will show how AI pipeline approaches monitoring online media vaccine sentiment can strengthen infodemic management, supporting earlier detection of emerging safety concerns, mis/disinformation signals, and shifts in vaccine confidence, while generating actionable intelligence for communication, surveillance and response.
5. Advancing vaccine vigilance in Indonesia: Jarir At Thobari — Pharmacology Professor and vaccinologist at Universitas Gadjah Mada, Indonesia — will discuss how AI-enabled surveillance can support responses to recent vaccine confidence challenges in Indonesia, highlighting the value of locally engaged partnerships in designing vaccine vigilance systems that are responsive to regional needs.
6. Global collaborative vaccine vigilance and the 100 days mission: Jim Buttery — Global leader in collaborative vaccine pharmacovigilance and multinational real-world evidence generation — will conclude the symposium with a forward-looking discussion on multinational vaccine vigilance frameworks and how federated real-world evidence approaches across globally connected surveillance networks, including low- and middle-income countries, can support rapid vaccine safety evaluation, accelerated evidence generation and pandemic preparedness goals aligned with CEPI’s 100 Days Mission.
To examine how emerging real-world evidence approaches are enabling faster, more connected and more scalable vaccine pharmacovigilance, providing practical insight into how innovative data sources, methods, and collaborative surveillance frameworks can strengthen rapid evidence generation, public confidence and preparedness for future vaccine rollout challenges and public health emergencies.
This symposium highlights contemporary pharmacoepidemiology approaches using real-world evidence to strengthen vaccine safety surveillance and rapid evidence generation. This is particularly relevant across the Asian region where expanding immunisation programs, growing digital health capability and advancement in collaborative surveillance models are accelerating innovation in vaccine pharmacovigilance.
Speaker
Dr. Hazel Clothier
Lead Epidemiologist
Murdoch Children’s Research Institute
Symposium Moderator
Biography
A/Prof Hazel Clothier is an infectious disease epidemiologist and vaccinology global health researcher with over 25 years’ experience in public health, vaccine safety surveillance and communicable disease outbreak and response within Australian and Pacific programs of health.
Hazel is Lead Epidemiologist of the Epidemiology-Informatics group and Program Lead for Post-licensure Vaccinology at the Centre for Health Analytics, Melbourne Children’s Campus (MCRI), and Senior Epidemiologist with the Global Vaccine Data Network (GVDN)™, a multinational collaboration conducting globally coordinated epidemiological studies on vaccine safety and effectiveness.
Her current research focus explores contemporary post-licensure vaccine safety surveillance systems incorporating novel signal detection and investigation methodologies using big data and large-linked datasets to inform real world evidence in support of equitable, safe and trusted immunisation programs.
Prof Jim Buttery
Co-director
Global Vaccine Data Network
Symposium Moderator and Presenter
Biography
Jim Buttery is the inaugural Professor of Child Health Informatics and Deputy Head of the Department of Paediatrics at the University of Melbourne, based at the Melbourne Children’s Campus Centre for Health Analytics. He is the Chief Research Information Officer and an infectious diseases physician at the Royal Children’s Hospital, Melbourne. He is also the Head of Epidemiology and Signal Detection of SAEFVIC - the Victorian Immunisation Safety Service, Head of Epidemiology Informatics research group at Murdoch Children's Research Institute, and co-director of the Global Vaccine Data Network. Jim leads a team of epidemiologists, data analysts and statisticians whose research revolves around innovative use of real-world data to answer important questions in infectious diseases epidemiology, vaccine safety and effectiveness.
Ms Daneeta Hennessy
Surveillance Operations Manager & Senior Epidemiologist
Murdoch Children’s Research Institute
Symposium Presenter
Biography
Daneeta is the surveillance operations manager and senior epidemiologist with Victoria’s vaccine safety service, SAEFVIC, within the Epidemiology-Informatics group at Murdoch Children’s Research Institute. She has previously held communicable diseases epidemiologist and biostatistician positions in Victoria and NSW where she took a lead role in integrating the use of microbial genomics and analysis of large linked administrative datasets into public health surveillance. She was named as an emerging leader in Victoria’s Top 50 Public Sector Women awards 2021 for her role in establishing COVID-19 surveillance and reporting for Victoria.
Mr John Mallard
Epidemiologist
Murdoch Children’s Research Institute
Symposium Presenter
Biography
John is an epidemiologist with specialising in pharmacoepidemiology, vaccine safety, and health informatics. At the Murdoch Children's Research Institute, he leads the operational delivery of Vaccine Safety Health Link, a statewide linked data platform designed to identify and investigate potential vaccine safety signals. His expertise lies in converting complex linked administrative and clinical datasets into scalable surveillance systems that generate actionable evidence for vaccine safety monitoring. Through the development of standardised signal detection and investigation frameworks, John has helped operationalise linked data for routine pharmacovigilance activities, supporting researchers, clinicians, and government stakeholders in evidence-based vaccine safety decision-making.
Dr Aishwarya Narendra Shetty
Epidemiologist
Murdoch Children's Research Institute
Symposium Presenter
Biography
Dr Aishwarya N. Shetty is an epidemiologist specialising in vaccine safety and real-world evidence. She analyses large Australian general practice datasets to investigate safety signals and inform national immunisation policy. Her work involves collaborative investigations with regulators and public health partners during major vaccine rollouts, strengthening post-marketing surveillance and supporting public confidence in immunisation programs.
Dr Gerardo Luis Dimaguila
Data Innovation Lead
Centre for Health Analytics
Symposium Presenter
Biography
Dr Gerardo Luis Dimaguila works at the intersection of public and clinical health, data analytics, and advanced technologies. He conceived and lead VaxPulse, an infodemic and misinformation risk assessment platform to help GPs, immunisers, and vaccine programmes stay ahead of emerging trends of misinformation. In responsive and strategic roles, he leads teams that are translating health information and AI solutions for public health and clinical outcomes. As a qualified specialist in digital health and informatics, he critically analyses challenges in implementing innovative health information solutions; developing evidence-based strategies; and integrating them into organisational business processes.
Dr Jarir At Thobari
Professor in Pharmacoepidemiology
Universitas Gadjah Mada
Symposium Presenter
Biography
Jarir At Thobari is Professor of Pharmacology and Director of the Clinical Epidemiology and Biostatistics Unit (CE&BU) and serves as a Board Member of the Center for Child Health/Pediatric Research Office (PRO) within the Faculty of Medicine, Public Health and Nursing at Universitas Gadjah Mada. A recognised leader in vaccinology and pharmacoepidemiology, Prof. Jarir At Thobari is actively involved in major national and global vaccine initiatives, including Indonesia's National Immunization Committee (KIN), the WHO Data Safety Monitoring Board for the New Oral Polio Vaccine, and the Asia Pacific Vaccine Research Network (APVRN), where he serves as Co-Chair. His expertise spans pharmacoepidemiology and pharmacovigilance, vaccinology and clinical trials, health technology assessment, and pharmacoeconomics.