Behind the Scenes: Running a Global Pharmacovigilance System

When you think of professional development, what comes to mind? Training courses, conferences, a promotion, a certificate on the wall? Rod Matthews argues that if development is something we attend, we’ve handed control of it to someone else.In this episode of Cognitio, host Tim Boyle shares highlights from LifeSciences Australia’s webinar Taking Control of Your Own Development. Rod reframes professional development as conscious choice: noticing the story we tell ourselves and the energy we bring, not just what we do.In this episode:Why “development equals training” is a trapHow the story in our head shapes our behaviour and our resultsShrinking big goals into simple daily practices that need no budget or approvalWhy the 10,000 hours rule is oversimplified, and how to make practice countPre-framing and debriefing with “good, tricky, different”Practical, honest and immediately usable for anyone working in life sciences who wants to grow on their own terms.Find more webinars, resources and ways to get involved at lifesciences.au

What does it actually take to keep a global pharmacovigilance system running across 20+ countries?In this episode of Cognitio, host Tim Boyle is joined by Erica Bell, Project Lead and Deputy QPPV at Commercial Eyes. Erica takes us inside her work leading a global patient safety team for a client headquartered in Asia, while also acting as the local affiliate for Australia, New Zealand and Canada.Erica covers:A day in the life of a PV project lead, from overnight inboxes to client meetingsWorking with affiliates around the world and keeping SOPs and safety data exchange agreements audit readyHer step-by-step approach to a potential safety issue, from first signal to health authority submissionCoordinating PSURs across multiple markets and business partnersResourcing, capacity planning and why you should manage from the contract, not from assumptionsPractical leadership advice on psychological safety, clarity and asking for help earlyWhether you work in drug safety, regulatory affairs or clinical operations, or you’re stepping into a project lead role for the first time, this episode offers a candid look at the people and processes that keep patients safe once medicines reach the market.This episode is adapted from a LifeSciences Australia pharmacovigilance webinar recorded on 3 September 2026.Find more webinars, events and membership information at lifesciences.au#Pharmacovigilance #DrugSafety #PatientSafety #LifeSciences

Your team is already using AI. The real question is what it can be trusted to do.In this episode of Cognitio, regulatory affairs specialist Chris Ozga, co-founder of Trial Edge AI, gives a candid look at where today’s AI tools fall short in regulatory work for medical devices, IVDs and software as a medical device. He’s clear from the outset that this is not an anti-AI talk. It’s a practical guide to using these tools without putting your submissions, your data or your patients at risk.In this episode:Why “shadow AI” is already in your organisation, and why banning it drives the risk undergroundThe core capability gaps: regulatory intent, hallucination, answer reversal and traceabilityOne setting to check today if you use a paid AI toolA four-tier framework for deciding what to delegate, supervise, verify or keep human-onlyWhat the TGA and FDA expect, and why you can’t blame the toolSimple stress tests to find where your AI skims, guesses or makes things upWill AI ever do the whole job? Chris’s answerAbout the guest: Chris Ozga is a senior regulatory affairs professional with more than a decade of experience guiding medical devices, IVDs and SaMD through TGA, FDA and EU MDR pathways. He began his career as a medical scientist in pathology and was an early adopter of AI-enabled digital pathology.This episode is drawn from a LifeSciences Australia webinar. Hosted by Dr Tim Boyle.More webinars, events and resources for life sciences professionals: lifesciences.au

What if leadership is measured not by what you achieve, but by what becomes possible because of you? Physician and global regulatory leader Zak Huang shares his enabling leadership framework: elevate the thinking, remove the obstacles, build the capability. Drawing on a real BLA filing where a 200-person company mapped 160 issues and filed three months after phase three data, Zak shows how the framework works in practice. He is joined by former CSL colleague Neama to talk about leading across cultures, influencing without authority, and whether leadership can be learned.

Why does fewer than one in ten drugs that enter clinical trials ever reach patients — and what can be done about it before a compound ever gets there?In this episode of Cognitio, Richard Knight, toxicologist and co-founder of Apconix, a nonclinical consultancy and lab working with biotech and pharma companies worldwide. Richard spent twenty years in global safety assessment at AstraZeneca, including several years as oncology safety lead, before starting Apconix a decade ago.Richard makes the case that toxicology shouldn't be treated as a late-stage hurdle, but as a design consideration from day one of drug discovery. Drawing on real AstraZeneca case studies — including the molecule that became the lung cancer drug Tagrisso — he shows how understanding a drug's target, its chemistry and the patient it's intended for can shape a better, faster, cheaper path through development. He closes with a grounded take on where non-animal testing methods and AI genuinely fit in the future of toxicology, and where the hype gets ahead of the reality.In this episode:Why toxicology should be a value-adding part of candidate selection, not a gate at the end of discoveryTwo companies, the same safety data, two very different (and defensible) callsHow early safety thinking helped one molecule beat its rivals to market, and outlast themA practical framework for assessing risk: the target, the chemistry, the patientWhere NAMs (non-animal methods) and AI genuinely help — and where they don't

Ethics approval is only the first hurdle for a clinical trial. Every site then needs its own research governance review, and that can cost patients precious time. In this Clinical Trials Day webinar, Angela Scheppokat, Manager Governance at the Royal Melbourne Hospital Office for Research, explains how Melbourne Health, Peter MacCallum Cancer Centre and the Royal Women's Hospital built a mutual governance pathway so one review can serve all three sites.Angela takes us from the deed and the pilot through to the first study, a CAR T trial approved in four days, which helped secure Australia's first site activation. She then turns to artificial intelligence, outlining how her hospital defines its risk appetite, draws on national and Victorian guidance, and works with its Digital Health Committee to oversee AI in research.A practical listen for research governance offices, trial sponsors and anyone building a flexible, risk-responsive process across sites.

Australia occupies an unusual position in global pharmaceuticals. It is regarded as a leader in cost effectiveness assessment, and at the same time it depends on innovation funded largely elsewhere. What does that dual role mean for patient access and for the medicines that reach this market?In this episode of Cognitio, Tim Boyle presents a LifeSciences Australia Market Access Special Interest Group webinar featuring Ella O'Nuallain, a health economics and policy researcher now working at NSW Health, who interviewed ten senior leaders across government and the pharmaceutical sector for her London School of Economics dissertation.Her findings show clear agreement on some reforms, and a striking divergence on one question: whether Australia is still a tier one launch market. The discussion covers funding buckets, PBAC engagement, risk sharing agreements and where reform goes next.

Every year in England and Wales, coroners write around 450 reports naming actions that could prevent future deaths. Roughly one in five involves a medicine. They are public, they are searchable, and according to our guest, essentially no pharmaceutical company is using them for pharmacovigilance.Dr Georgia Richards is an epidemiologist at King's College London and the founder of the Preventable Deaths Tracker, the first platform to digitise coroners' reports and turn them into live, searchable data. She is Australian, trained at Oxford, and spent a period as a safety epidemiologist at AstraZeneca.In this episode she explains how the coronial system works, what the tracker has found about opioids, fentanyl patches and anaphylaxis, and why she considers this an underutilised safety data source.Content note for show notes: this episode discusses death investigations, including deaths by suicide and overdose, in a research and public health context.

Our sector speaks in technical language, and that language is precise, accurate and often impenetrable to the people it is meant to serve. In this episode of Cognitio, Tim Boyle hands the microphone to Jessamy Gee, founder and director of Think in Colour and Australia's first IFVP certified master visual practitioner.Jessamy works as a graphic recorder, translating complex discussion into a visual record while it is happening, across healthcare, security, agriculture and public consultation. She makes the case for why visuals change comprehension, memory and emotional connection, runs a short drawing exercise you can do while you listen, and explains how she captures emotionally charged lived experience without flattening it into a data point.Presented close to complete, as she delivered it.

Every early phase trial ends with a number, and with a judgement about whether that number means anything. In this episode of Cognitio, Professor Rory Wolfe of the Monash University Clinical Trial Centre and medical statistician Dr Alan Herschtal set out how biostatistics underpins that judgement, and why it belongs at the first planning meeting rather than the last.They cover why clinical development is staged the way it is, what a p value actually tells you and what it does not, why confidence intervals carry more information than significance alone, and why getting sample size wrong is an ethical failure and not just a budget problem. The episode closes on phase one specifics: dose escalation, the three plus three design, and the questions worth asking whatever your role.