Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?

In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.

Tune in to find out:

• How to keep up with rapid developments in AI technology
• Why model and performance transparency both matter
• How to protect sensitive patient data when using AI

Want to know more?

Listen to the first part of the interview here.

In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.

Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.

Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article.

Other recent UMC publications cited in the interview or relevant to the topic include:

• a pre-print on the revised vigiMatch algorithm for duplicate detection
• an article on the pitfalls of disproportionality analysis
• a pre-print on critically appraising AI applications for rare-event recognition

For more on the ‘black box’ issue and maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive.

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About UMC
Read more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?

In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.

Tune in to find out:

• Why pharmacovigilance needs specific AI guidelines
• How a risk-based approach to AI regulation works
• Where in the PV cycle is human oversight most needed

Want to know more?

Listen to the second part of the interview here.

In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.

Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.

Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. His favourite definition of AI remains the one proposed by Jeffrey Aronson in Drug Safety.

For more on maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive.

The AI methods developed by UMC and cited in the interview include: 

• vigiMatch for duplicate detection
• vigiGroup for clustering
• vigiRank for signal detection
• vigiGrade for case report completeness scoring

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About UMC
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Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.

Tune in to find out:

• Why we need a Patient Safety Day
• How to prevent common medication errors in children
• How to build child-friendly healthcare environments

Want to know more?

Visit the World Health Organization’s campaign website to learn more about World Patient Safety Day and download campaign materials.

You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events.

For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive:

• The KIDs List
• What’s trending in pharmacovigilance?

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This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was Improving information capture for safer use of medicines. The episode is an abridged recording of the concluding fireside chat, where Angela Caro-Rojas (president of ISoP), Linda Härmark (director of the Drug Safety Research Unit in the UK), Ghita Benabdallah (national pharmacovigilance centre of Morocco, member of the IsoP advisory board), and Daniele Sartori (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient engagement in pharmacovigilance.

The symposium was a collaboration between ISoP and UMC.

Want to know more?

• Visit the official website of the 2025 ISoP Mid-Year Symposium to learn more about its sessions, speakers and chairs. 
• Not patient but im-patient – read about Sara Riggare’s research on patient engagement and other topics.
• Listen to Henry Zakumumpa talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters.
• Read about the PhD project of Tommy Emil Dzus, Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies, at Oslo Metropolitan University, Norway.
• Sabine Koch is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm.
• Details on Mikael Hoffman's research can be found on his profile page on ResearchGate.
• Take a look at what’s in store for participants at the 24th Annual Meeting of ISoP in Cairo, on October 24–27, 2025.
• Visit the websites of the Drug Safety Research Unit (DSRU), ISoP, Centre Anti Poison et Pharmacovigilance du Maroc, and Uppsala Monitoring Centre, to find out more about their work.

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Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new routes have been introduced to facilitate reporting for patients and healthcare professionals, including email, WhatsApp and the Med Safety smartphone app. Henry Zakumumpa is a researcher at Makerere University in Kampala, Uganda. He has recently performed a qualitative study to learn more about drivers and obstacles for quality in adverse event reporting from patients and healthcare professionals in Uganda. He joins the Drug Safety Matters studio to help us get a more nuanced picture of challenges and opportunities around the issue.
 
 

Tune in to find out:

• Why are HIV patients in Uganda reluctant to report adverse events to their healthcare providers?
• What are the challenges with reporting via WhatsApp?
• How can regulators and PV centres foster better quality in incoming adverse event reports?

Want to know more?

• Listen to Henry talk about the safety of HIV medications in this 2022 episode of Drug Safety Matters.
• Visit this CARTA (Consortium for Advanced Research Training in Africa) profile page to learn more about Henry’s research.
• Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews (British Journal of Clinical Pharmacology, 2023)
• Improving adverse drug event reporting by healthcare professionals (Cochrane Database Systematic Review, 2024)

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There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions.

The Research section at Uppsala Monitoring Centre has a team that is currently focussing their efforts on pregnancy-related pharmacovigilance (PV). In this episode, data scientists Sara Vidlin and Levente Papai, and senior pharmacovigilance scientist Lovisa Sandberg from this team, discuss complexities and challenges of pregnancy-related PV, and new solutions for addressing those challenges. 

Tune in to find out

• Why is the world still behind when it comes to pregnancy-related PV?
• What are the challenges faced by PV assessors wanting to look at pregnancy cases?
• How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events?
• How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases?

How to use the VigiBase pregnancy algorithm

• Users of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches. 
• In the qualitative view in VigiLyze, click on “Filter” -> “Patient” -> “Pregnancy” to apply the filter.

Want to know more?

• Read about the VigiBase pregnancy algorithm in this Uppsala Reports article and in this scientific paper, published in Drug Safety in 2025. 
• EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. EURAP - International Registry of Antiepileptic Drugs and Pregnancy
• The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files
• The IMI-concePTION project
• Medical Dictionary for Regulatory Activities (MedDRA) support documentation
• Zaccaria C, Piccolo L, Gordillo-Marañón M, et al. Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance. Drug Safety. 2024
• Sakai T, Mori C, Koshiba H, et al. Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Dispro

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Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. 

Tune in to find out

• How the types of ADRs reported for animals and humans differ
• How the many species and breeds included in veterinary PV affect the ADR coding 
• What the Veterinary Big Data Strategy is

... and much more!

Want to know more?

• The public portal of the European Union Veterinary Pharmacovigilance Database.
• One Health – an integrated approach to the well-being of people, animals and the environment.
• A survey of veterinary professionals in Sweden, about practices and attitudes in relation to ADR reporting.
• A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicines. 
• The EMA Big Data strategy for veterinary medicines and Data quality framework for medicines regulation
• Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool
• VetCompass - Royal Veterinary College, RVC
• Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)
• Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA)

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About UMC
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Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. 
 

Tune in to find out:

• What are the similarities and differences between veterinary and human pharmacovigilance?
• How is animal health connected to public health? 
• What types of adverse events are reported on the veterinary side compared with the human side? 
• What can be found in the EU veterinary pharmacovigilance database? 

Want to know more?

• The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found here. 
• The public portal of the European Union Veterinary Pharmacovigilance Database.
• WHO's information page on One Health, an integrated approach to the well-being of people, animals and the environment.
• A survey of veterinary professionals in Sweden, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information.
• A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicinal products. 
• A study looking at suspected adverse drug reaction reporting in veterinary free‐text clinical narratives.
• The EMA Big Data strategy for veterinary medicines in the EU. 
• Data quality framework for medicines regulation | European Medicines Agency (EMA)
• Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool
• VetCompass - Royal Veterinary College, RVC
• Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)
• The Swedish Medical Products Agency's online reporting form for suspected adverse drug reactions in animals (In Swedish).  

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About UMC
Read more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias. 

Tune in to find out:

• What challenges are PV assessors faced with, when working with narratives? 
• How could automation of certain tasks help streamline narrative analyses in the future?
• How can reporters craft narratives that effectively document adverse events? 

Want to know more?

• Pharmacovigilance assessors’ experiences interacting with narrative fields in spontaneous reports: an exploratory interview study – poster presented at the 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”, 1–5 October 2024 Montreal, Canada.
• Current Challenges in Pharmacovigilance: Pragmatic Approaches, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices. 

Join the conversation on social media
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Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in monitoring drug safety in older patients.

 Tune in to find out:

• What makes older adults especially at risk of experiencing adverse drug reactions and medication errors
• Why frailty is far more useful than age in predicting adverse drug reaction risk
• How pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.

Want to know more?

This interview all started with Giovanni's Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it here.

For a summary of the key points discussed in this interview, read Giovanni’s paper on the status of drug safety in geriatric patients.

If our discussion of frailty piqued your interest, read this paper on the biology of frailty and how this impacts clinical pharmacology, this multi-centre cohort study that shows frailty is significantly correlated with MRH, and this commentary advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such.

As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his paper.

For more on prescribing cascades, their prevention, detection, and reversal, read this paper by Brath and colleagues.

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We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!

About UMC
Read more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.