Join us in Windhoek🇳🇦 for the ISoP Africa Chapter Meeting!

We're thrilled to host a pre-conference workshop on #pharmacovigilance communications and a session on SFMPs in #VigiBase.

❗️Register by 17 April to secure the early-bird rate.

Event details 👉 isopafrica.com

Critical Appraisal of Artificial Intelligence for Rare-Event Recognition: Principles and Pharmacovigilance Case Studies - Drug Safety Many high-stakes artificial intelligence (AI) applications target low-prevalence events, where apparent accuracy can conceal limited real-world value. Relevant AI models range from expert-defined rules and traditional machine learning to generative large language models (LLMs) constrained for classification. As the effort and expertise required to develop modern AI decrease, there is a risk that organizations devote too little time to understanding their limitations and sources of error. We outline key dimensions for critical appraisal of AI in rare-event recognition, including problem framing and test set design, prevalence-aware statistical evaluation, robustness assessment, and integration into human workflows. In addition, we propose an approach to structured case-level examination (SCLE), to complement statistical performance evaluation, and a set of considerations to guide procurement or development of AI models for rare-event recognition. We instantiate the framework in pharmacovigilance, drawing on three studies: rule-based retrieval of pregnancy-related reports, duplicate detection combining machine learning with probabilistic record linkage, and automated redaction of person names using an LLM. We highlight pitfalls specific to the rare-event setting including optimism from unrealistic class balance and lack of difficult positive controls in test sets—and show how cost-sensitive targets align model performance with operational value. While grounded in pharmacovigilance practice, the principles generalize to domains where positives are scarce, and error costs may be asymmetric.

In a new article, UMC researchers outline key dimensions for critical appraisal of #AI for rare-event recognition in #pharmacovigilance:

🔹Problem framing and test set design
🔹Prevalence-aware statistical evaluation
🔹Robustness assessment
🔹Integration into human workflows

#OpenAccess below👇

Adverse events can affect more than just humans 🐾

Explore the world of veterinary #pharmacovigilance this #VetMedSafetyDay. Listen to our two-part #DrugSafetyMatters episode featuring James Mount to learn more:

Part 1 🎧 https://ow.ly/ypfz50UFlG8
Part 2 🎧 https://ow.ly/9GlB50UVHqC

Pharmacovigilance Services Market Insights and Forecast Report 2026 www.marketresearchfuture.com/reports/phar...
#Pharmacovigilance #DrugSafety #HealthcareServices #ClinicalResearch #Innovation #ServiceMarket

🎧 Michele Fusaroli and Eugene van Puijenbroek join us on the #DrugSafetyMatters podcast to discuss the common pitfalls of disproportionality, how to avoid them, and why guidelines and a cultural shift are needed to prevent misuse.

Listen in today 👉 https://ow.ly/Q0FA50YCMkS

#pharmacovigilance

Fundamental & Clinical Pharmacology: Vol 40, No 2 Click on the title to browse this issue

March issue now available!
#fundamental #clinical #pharmacology #statin #pharmacovigilance #addictovigilance #cannabis #ambroxol #dupilumab #buscopan #inflammation #cytokine #SGLT2i #heart #drug #repositioning #antinociceptive #SFPT @wileyhealth.bsky.social
onlinelibrary.wiley.com/toc/14728206...

Stay informed about all things #pharmacovigilance by listening to our podcast #DrugSafetyMatters. Some of our latest episodes cover:

🩻 Medical devices
🌐 The WHO Global Smart PV Strategy
🤖 Artificial intelligence in PV

🎧 Listen now at 👉 https://www.drugsafetymatterspod.org

#AI #MedicalDevices

Duplicate detection in #Pharmacovigilance: a scalable predictive modelling approach Date Submitted: Mar 13, 2026. Open Peer Review Period: Mar 20, 2026 - May 15, 2026.

Reminder>> Duplicate detection in #Pharmacovigilance: a scalable predictive modelling approach (preprint) #openscience #PeerReviewMe #PlanP

🔍 What is #pharmacovigilance?

Reports of potential side effects from patients and healthcare professionals help us improve patient safety worldwide.

Find out how the #MedSafetyCycle works in this illustrated story 👉 ow.ly/EoZ950LOJE4

Duplicate detection in #Pharmacovigilance: a scalable predictive modelling approach Date Submitted: Mar 13, 2026. Open Peer Review Period: Mar 20, 2026 - May 15, 2026.

Duplicate detection in #Pharmacovigilance: a scalable predictive modelling approach (preprint) #openscience #PeerReviewMe #PlanP

« Des patients sont morts d’une perforation d’organe » : le nicorandil, vingt ans d’alertes ignorées pour un médicament peu efficace DÉCRYPTAGE - La revue « Prescrire » réclame le retrait immédiat de ce médicament de cardiologie encore prescrit à plus de 50 000 patients en France, et qui entraîne des ulcérations parfois graves.

sante.lefigaro.fr/medecine/des...

Pour le Figaro je reviens sur les données de pharmacovigilance, les études récentes, les positions de l’ANSM et la baisse encore limitée du nombre de patients exposés.

#pharmacovigilance #santé #médicaments #sécuritédespatients #cardiologie #Prescrire #ANSM

🎧 We're celebrating 50 000 downloads of the #DrugSafetyMatters podcast! 🎉

Thank you to our avid followers for tuning in and to our guest speakers for sharing their unique perspectives on topical issues in #pharmacovigilance.

Listen to all episodes 👉 https://www.drugsafetymatterspod.org/

Safety evaluation of selective RET inhibitors in patients with #lungcancer: a real-world #pharmacovigilance study👥

t.co/Leaz1RbN1Y

#lcsm

Depuis bientôt 10 ans, les pharmacologues de l'Université de Toulouse nous permettent d'intervenir auprès de leurs étudiants : historique du DES, ses conséquences toujours actuelles, les actions de l'association...

Beaucoup échanges lors de ces deux heures. 🙏à leurs professeurs de nous inviter ! 👉www.des-france.org/2026/03/11/6-mars-2026-n...
#Distilbène #Diethylstilbestrol #pharmacovigilance #perturbateursendocriniens

Real-time drug safety? Big shift. FDA AEMS merges seven systems into a public adverse-event dashboard—faster signal access for regulators and analysts, but expect more noise. Full breakdown → future.xsbrt.com/DrugSafetyDataRealTimePu... Save or reply #pharmacovigilance

🚺 This #InternationalWomensDay, we're celebrating how women are shaping the field of #pharmacovigilance.

Read why our staff nominated Manal Younus, Marie Lindquist, Rachida Soulaymani Bencheikh, and Shanthi Pal as inspiring women in #pharmacovigilance in the photos below👇

A new preprint compares the design and scope of three rule-based algorithms developed to retrieve pregnancy-related adverse event reports across major #pharmacovigilance databases.

💬 Read the study and share your feedback here 👉 https://ow.ly/wI8F50Yq2Ry

CIOMS Cumulative Glossary, with a focus on Pharmacovigilance (Version 2.3) • COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES This glossary compiles the terms and definitions from published CIOMS reports, with a focus on pharmacovigilance. We welcome all feedback. Please e-mail your recommendations to info@cioms.ch.

📖 Looking for a glossary of #pharmacovigilance terms and definitions?

Version 2.4 of the #CIOMS Cumulative Glossary compiles all terms and definitions included in WG reports on pharmacovigilance. New to this edition is the inclusion of terms on #AI in PV👇

ArisGlobal Unveils NavaX Translation to Streamline Global Pharmacovigilance Processes ArisGlobal introduces NavaX Translation, an innovative solution designed to automate certified translation processes in global pharmacovigilance, ensuring efficiency and compliance.

ArisGlobal Unveils NavaX Translation to Streamline Global Pharmacovigilance Processes #USA #Boston #Pharmacovigilance #ArisGlobal #NavaX

Disproportionality analysis is the go-to method in #pharmacovigilance, but it can easily be misused. How can we recognise common sources of error, mitigate biases, and interpret this scientific tool?

💬 #AskUsAnything – share your questions for @fusarolimichele.bsky.social and Eugene by 1 March👇

A close-up photo of various medicine capsules

🛑 MYTH: Pharmaceutical companies create a new drug and immediately start selling it to the public.
✅ FACT: In reality, medicines go through years and years of detailed testing and strict safety checks before they ever reach patients. #pharmacovigilance #medicine
Let’s bust some common myths! 🧵👇

Guidance on pharmacovigilance procedures

Safety checks continue even after the drug is released onto the market.

There’s routine safety reporting, different risk management plans, and post authorisation studies.

All of these complex processes are in place to maintain #pharmacovigilance and public trust. ⚠️

The science and activities focused on detecting, assessing, understanding, and preventing adverse effects or other drug-related problems.

Welcome to Wednesday Words, where I will define one word used in biotechnology or biopharma each Wednesday morning!

If you want to learn more, check out: sbee.link/caf4tu3wnp
#wednesdaywords #biotechnology #biopharma #ClinicalTrials #Pharmacovigilance #science

Medical Cannabis Use in France: An Observational Safety Study Based on the RECANN Registry and the Pharmacovigilance/Addictovigilance System From 2021 to 2024 Introduction The French National Agency for Medicines and Health Products Safety implemented in 2021 a nationwide experimentation for medical cannabis (MC), designed to assess the feasibility of imp...

Now available:
Medical Cannabis Use in France: An Observational
Safety Study Based on the RECANN Registry and the
Pharmacovigilance/Addictovigilance System From 2021
to 2024
#pharmacology #cannabis #pharmacovigilance #addictovigilance @wileyhealth.bsky.social
onlinelibrary.wiley.com/doi/epdf/10....

Une parole rare, un témoignage aussi court que fort.
👉https://youtu.be/eHhF5b7IRfM?si=xcDSEq6pVwaQ1PiS
#podcast Pour témoigner, transmettre "nos" histoires du #Distilbène (DES #diethylstilbestrol). #perturbateursendocriniens #Information #pharmacovigilance + d'info www.des-france.org/2024/03/17/1...

The Rising Misuse of Pharmacovigilance Reporting Systems: A Threat to Evidence‐Based Medicine In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user-friendly dashboards. This h...

📖 A recent perspective piece in Clinical Pharmacology & Therapeutics, ft. contributions from @fusarolimichele.bsky.social, explores the rising misuse of #pharmacovigilance reporting systems and suggests pathways forward to conduct robust disproportionality analyses.

#OpenAccess at the link below👇

Join us at globalpvcongress.in
#pharmacovigilance

Perspective on Better Access to Data and Data Integration in Pharmacovigilance: Information from a Focus Group - Drug Safety A focus group organised by the Drug Safety Research Unit (DSRU) International Working Group (IWG) on New Developments in Pharmacovigilance discussed current challenges and opportunities in pharmacovig...

How can we improve data access and data integration in #pharmacovigilance?

A recent article in #DrugSafety outlines the findings of a focus group organised by the Drug Safety Research Unit IWG on New Developments in Pharmacovigilance.

📖 Read the #OpenAccess at the link below👇

Disproportionality analysis: fast, but fragile, and easy to misuse Disproportionality analysis is pharmacovigilance’s signal-detection workhorse. But more reports do not mean better evidence, and crude results can mislead.

Disproportionality analysis has become the workhorse of signal detection. However, published studies often overlook the inherent biases within adverse event reporting databases.

Michele Fusaroli explores how #pharmacovigilance can move past crude disproportionality in #UppsalaReports👇

Atorvastatin‐Associated Liver Injury: Outcome After Statin Rechallenge Background Statin-induced liver injury is frequent and usually not severe. The aim of the present study was to describe the safety of statin rechallenge after atorvastatin-induced liver injury becau...

Now available in Open access:
Atorvastatin-Associated Liver Injury: Outcome After Statin Rechallenge
#fundamental #clinical #pharmacology #liver #statin #drug #treatment #pharmacovigilance @sfpt-fr.org @wileyhealth.bsky.social @jlcracowski.bsky.social

onlinelibrary.wiley.com/doi/10.1111/...