World Drug Safety Conference Europe 2025

By Dr Stephanie Jones
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7th and 8th October 2025
It’s been a whirlwind of a conference; presentations by inspiring speakers and conversations with visionary leaders in the PV world! It was a pleasure to sponsor a stand and meet so many people who were interested in finding out about our services.

Our team, Hannah Kerfoot, Angus Bryne, Luka Pinches and (Our President) Ian Pinches were fantastic!
We split attendance of all the informative talks between us and will be bringing back our learnings to the rest of the medical reviewers at home!
Some Insights…
– Shahin Kauser, from the Medicines and Healthcare products Regulatory Agency, gave some tips to fulfil requirements of conditional authorisations, such as remembering to submit the distribution for your aRMMs in addition to Annex 6.
– Maria Stupar, from the Grünenthal Group, taught us to “Train the mindset: Null hypothesis should always be ‘This may be an ADR’”
– A brilliant quote from a panel discussion with Mariette Boerstoel-Streefland, Felix Arellano and Serban Ghiorghiu: “good is good enough”. They emphasised that we should not promise perfection with AI, but aim for incremental proven results.
– Ercen Atillasoy told us to:
Shift the mindset: we are facilitators not gate keepers!
Culture eats strategy for breakfast!
️The benefit risk profile is dynamic.
– Dr Jay Dave revealed there was a 430% increase in combination drug-device products in the past decade!
– Mark Cawley got the audience to participate using RACI, showing how Jazz Pharmaceuticals uses business excellence tools in patient safety.
– Stéphanie Tcherny-Lessenot from Sanofi illustrated the benefit risk guidance from CIOMS (Council for International Organisations of Medical Sciences) with her insights as a member of the Working Group, and emphasised that important does not always mean serious – non serious events could be important risks too!
Some quotes of the conference:
– Collaboration is a culture
– AI developers are like dragon trainers
– Successful implementation of AI is like the Loch Ness Monster: everyone is looking for it but no one has ever seen it!
It was fantastic to be able to hear from and speak with so many like-minded people, all working to make patients safer. See you next year!
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