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Posts by Uppsala Monitoring Centre

Safe by perception, risky in practice? What vitamin B6 and turmeric teach us about complementary medicines Complementary medicines are widely used and often perceived as safe, yet high doses, product stacking, and unclear labelling can quietly increase the risk of harm.

Many consumers are unaware that high doses, product stacking, and unclear labelling can quietly increase the risks of the vitamins, minerals, or herbal products they consume.

Discover vitamin B6 and turmeric can teach us about safe use in #UppsalaReports:

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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

6 days ago 0 0 0 0
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Pharmacovigilance of a high-risk drug: Can AI save us? An Australian research team is using artificial intelligence to improve the safe dosing of unfractionated heparin, a high-risk drug linked to serious side effects.

Harnessing #AI to improve safe dosing of high-risk drugs 🤖

An Australian🇦🇺 research team shares how they're turning to #MachineLearning to improve safe dosing of unfractionated heparin (UFH), an anticoagulant linked to serious side effects, in #UppsalaReports👇

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The 3rd #CIOMS webinar on #AI in PV is here! This edition is scheduled for Trans-Atlantic audiences and features UMC's Niklas Norén and expert panellists:

📆 Monday, 20 April
🕑 14:00–15:30 CEST / 8:00–09:30 EDT
📍 Online

Spaces are limited. Register to attend today 👉 https://ow.ly/uGQG50YGUzQ

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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👇

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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

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The world's largest scientific network supporting public health. And you've probably never heard of it.

800+ centres. 80+ countries. 4000+ projects-just this year.
All working towards one goal: a healthier world.

The world's largest scientific network supporting public health. And you've probably never heard of it. 800+ centres. 80+ countries. 4000+ projects-just this year. All working towards one goal: a healthier world.

So, what exactly are WHO Collaborating Centres?
Universities. Hospitals. Research labs. Leading public health scientists have been working alongside WHO since 1948.

They provide scientific expertise, laboratory services, training, and conduct research.

So, what exactly are WHO Collaborating Centres? Universities. Hospitals. Research labs. Leading public health scientists have been working alongside WHO since 1948. They provide scientific expertise, laboratory services, training, and conduct research.

What happens when the world's best scientists work together? Diseases get detected faster. Treatments get better. Health policies get smarter.

WHO Collaborating Centres connect some of the world's leading scientific experts, working together so no country has to face its health challenges alone.

What happens when the world's best scientists work together? Diseases get detected faster. Treatments get better. Health policies get smarter. WHO Collaborating Centres connect some of the world's leading scientific experts, working together so no country has to face its health challenges alone.

Learn about the WHO Collaborating Centres. 800+ strong. Working every single day, so the world's health decisions are built on the best science available. 

Together for Health #StandWithScience 💙

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The WHO PIDM in Focus - YouTube The WHO PIDM was created in 1968 to ensure that evidence about harm to patients was collected from as many sources as possible. This enables individual count...

Today is #WorldHealthDay!

UMC is proud to be one of the nearly 800 WHO Collaborating Centres worldwide, making science accessible & serving as visible, trusted voices of scientific facts & solutions.

Learn more about our work with the WHO Programme for International Drug Monitoring in our series:

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🎧 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

2 weeks ago 0 0 0 0
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International Medicinal Product Information Documents: A Quantitative Content Analysis of Instructions for Preventing, Mitigating, and Monitoring Adverse Drug Reactions - Drug Safety Introduction Medicinal product information documents (PIDs) detail clinical characteristics and instructions for monitoring, preventing, and mitigating adverse drug reactions (ADRs). They vary across ...

How complete are medicinal product information documents (PIDs) when it comes to the prevention, mitigation, and monitoring of adverse drug reactions?

A new article in #DrugSafety assesses and compares the completeness of PIDs across countries, covering 364 products and 627 signals.

#OpenAccess👇

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Patients feel it first: Strengthening medicine safety through patient reporting Patient reporting can surface safety signals sooner, but ADR systems are hard to navigate. Can a consumer-centred, co-designed digital approach make reporting easier?

Patients are the first to feel the effects of medicines, yet many do not report the adverse events they experience.

Renly Lim and Eyob Alemayehu Gebreyohannes share how a consumer-centred, co-designed digital approach can make ADR reporting easier in #UppsalaReports👇

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💊 Adherence to complicated medication regimens

Complex medication schedules can lead to missed or double doses.

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💊 Physical impairment

Elderly patients may have difficulties taking their medicines, such as swallowing tables, opening packaging, or reading instructions.

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💊 Polypharmacy

Taking multiple medications increases the risk of drug interactions and side effects.

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As we age, we often rely on medications to manage our health. This makes us more vulnerable to #MedicationErrors.

Learn more about the factors impacting elderly patients in the thread below👇 and read our #DeepDive into medication errors in #UppsalaReports 👉 ow.ly/F4q150W5qYF

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The WHO PIDM in Focus - Brazil Part 2: Standardisation and industry
The WHO PIDM in Focus - Brazil Part 2: Standardisation and industry YouTube video by Uppsala Monitoring Centre

🎥 We travel to Brazil🇧🇷 in the latest WHO PIDM in Focus film.

Learn how @anvisaoficial.bsky.social, Instituto Butantan, and other local stakeholders are making use of UMC's tools and training to foster collaboration and harmonise safety data to ensure #PatientSafety below👇

3 weeks ago 1 0 0 0
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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

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🔍 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

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Don't miss the 2nd #CIOMS webinar on #AI in PV. This edition is scheduled for audiences in the Asia-Pacific region and features UMC's Niklas Norén and expert panellists:

📆 Thursday, 26 March
🕣 08:30–10:00 IST / 20:00–21:30 PDT
📍 Online

Register today 👉 https://ow.ly/5XSK50Ywazh

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Early risk planning: why development risk management plans matter What if risk management began earlier? DRMPs serve as a framework for safety thinking in clinical development and support better benefit–risk decision-making.

What if structured risk thinking started in the early phases of clinical development?

Learn how development risk management plans (DRMP) can help shift the risk mindset to support better benefit–risk decision-making and #PatientSafety in #UppsalaReports:

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#MedicationErrors are a leading cause of avoidable harm in healthcare, affecting millions of people worldwide each year.

By understanding the different types of errors and finding effective ways to prevent them, we can improve the safety of medicines for everyone ✅

👉 http://ow.ly/F4q150W5qYF

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🎧 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/

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Underreporting in pharmacovigilance: Where do we go from here? While underreporting remains a persistent global challenge, innovative approaches are showing promise in different regions

Historical data suggest that only 2–4% of non-serious and around 10% of serious adverse events are reported each year.

Learn how a multi-modal approach is essential to breaking down barriers and addressing the complex web of factors driving underreporting today in #UppsalaReports👇

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The WHO PIDM in Focus - Malawi
The WHO PIDM in Focus - Malawi YouTube video by Uppsala Monitoring Centre

Malawi🇲🇼 has been a member of the WHO PIDM since 2016. Anderson Ndalama shares how #VigiFlow and #VigiMobile have strengthened #VaccineSafety reporting, improved efficiency, and significantly increased the number of AEFI reports submitted in the film below👇

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🚺 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👇

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PVgravID - Identifying Pregnancy Reports in Pharmacovigilance Databases Implementation and comparison of algorithms for retrieval of pregnancy reports from pharmacovigilance datasets (VigiBase and FAERS).

We have also released PVgravID, an #OpenSource #R package that implements the algorithms described in the study. Access it for free on #GitHub:

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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

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Cross-functional collaboration among professionals in quality assurance, engineering, and drug safety is needed to ensure the safety of medical devices.

🎧 We chat #MedicalDevice safety with Omar Aimer, President of ISoP, in part 2 of this #DrugSafetyMatters episode 👉 https://ow.ly/y9WQ50Yp7sI

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UMC's Niklas Norén will discuss the #CIOMS WG XIV report on #AI in PV and the chapters on validity/robustness and transparency. The webinar also features an expert panel discussion:

📆 Friday, 6 March
🕑 14:00–15:30 CET
📍 Online

Spaces are limited. Register today 👉 https://ow.ly/X4FY50YnSCp

1 month ago 0 0 0 0
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Orphan Drugs: Hope for rare disease communities Orphan drug monitoring emerges as a critical lifeline for rare diseases, offering hope to patients with uncommon medical conditions.

Rare diseases and #OrphanDrug monitoring represent a complex and evolving landscape in healthcare and pharmaceutical research.

This #RareDiseaseDay, learn how a new era of innovation must be complemented by post-marketing surveillance in #UppsalaReports:

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