Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.  

In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe. 

Tune in to find out:

• What defines a medical device and how prevalent they are in our society
• Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short
• How global initiatives aim to strengthen safety monitoring standards

Want to know more?

 If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.

Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.

Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.

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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.

This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy. 

In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.

Want to know more?

• Read WHO’s “Global smart pharmacovigilance strategy” (Geneva: World Health Organization; 2025). 
• Explore WHO’s work on pharmacovigilance through the Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team.
• Learn more about regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) for medicines and vaccines.
• Discover the WHO network for regulatory systems strengthening – the Coalition of Interested Parties (CIP), of which UMC is a member.
• Visit the UMC website to find out more about the WHO PIDM and UMC’s role in it.

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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 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.

The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025.

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.

The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025.

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
• WHODrug Koda for automated coding

Join the conversation on social media
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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.

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

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.

Join the conversation on social media
Follow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.

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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.

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)

Join the conversation on social media
Follow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.

Got a story to share?
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.

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

Join the conversation on social media
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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.

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)

Join the conversation on social media
Follow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.

Got a story to share?
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.

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).  

Join the conversation on social media
Follow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.

Got a story to share?
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.