Same AI tool, two different regulatory verdicts
Why the way you classify an AI use case in safety shapes everything that follows
18 November 2026 | 11:00 AM CET | Online
A chatbot that answers internal HR or IT questions is not a GxP matter. The same chatbot answering patients or healthcare professionals is. As soon as someone mentions an adverse event, it becomes a pharmacovigilance intake channel, with every duty that comes with it.
The tool has not changed. The workflow has, and so has the regulatory verdict.
One tool, many verdicts
The same pattern repeats across safety work:
- Machine translation: an internal gist is one thing, an SmPC, PIL or ICSR translation is another.
- Literature screening: competitive watch is not the same as GVP Module VI case detection.
- GenAI drafting: meeting minutes are not the same as responses and narratives filed in controlled systems.
One of the most common mistakes in adopting AI in safety is classifying the tool instead of the workflow. That classification determines how much validation is needed, what must be traceable and where the expert has to sign.
Drawing the line in real operations
In our upcoming PLG webinar, experts from PLG’s Safety & Vigilance and Digital Innovation teams will show how they draw that line in practice, from medical information and literature monitoring to case intake and translation.
What you will take away:
- A simple one question test to size the validation effort for any AI use case.
- What happened when PV experts started reviewing the AI’s reasoning, not just its output.
- Why, with model performance now broadly comparable, the real differentiator is a workflow that holds up on the day of the inspection.
Who will be speaking
Speakers: Gabrièle Piaton and Wenna Zhang
Moderator: Hélène Masset
Date and time: 18 November 2026, 11:00 AM CET
If you are working on AI in pharmacovigilance or medical information and want to talk about your own use cases, discover our Safety & Vigilance services or contact our team.