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?

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
• WHODrug Koda for automated coding

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.

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?

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.

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.

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.