The task has grown, the team usually has not
Marketing authorisation holders must regularly review the scientific literature for reports of suspected adverse reactions to their active substances. The volume of publications is growing, as is the number of marketing authorisations in many portfolios — the number of people doing the screening rarely is.
This makes the question of tools unavoidable. It is just often asked the wrong way: not as “will AI replace screening?”, but as “which step can it take over without compromising traceability?”.
What can sensibly be automated
Pre-sorting. Filtering out of a hit list the publications that obviously have no connection to the active substance is a task with clear criteria and a high degree of repetition. The same applies to merging duplicate hits from several databases and recognising publications that have already been processed.
Translation support for local literature is also a realistic use case — provided that the subsequent expert review is carried out by a person who can put the context into perspective.
What cannot be delegated
The assessment of whether a publication contains a suspected adverse reaction. And the decision as to which of the four minimum criteria it provides. Both are expert judgements that, if in doubt, must be justified to an authority.
The practical pitfall is not the false hit but the correct one that was filtered out. A system that discards too much produces a clean list and an unclean reporting situation. Anyone who automates therefore needs sample checks on the discarded hits — not just on the retained ones.
The process decides, not the tool
GVP Module VI does not require any particular technology. It requires that searches are performed, at what interval, with what search strategy and with what result — documented, even when nothing is found. A tool does not change this; it has to fit into this documentation.
The most common gap is therefore not a technical one either. It is that searches are only carried out globally in the major databases, while the local specialist literature of the other countries in which marketing authorisations are also held is missing.
If you need an outside perspective
VigiPRO takes over literature screening globally via Medline and Embase, and locally in the German-speaking region and in further countries inside and outside the EU — with a documented search strategy and a fixed interval.