Institut pour la Recherche en Santé Publique (IReSP)
This sponsor has funded 1 studies across 1 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 7549 | Finalised | EPIHAM: Drug-induced liver injury leading to hospital admission: a study in national healthcare insurance databases | Yes | Yes |
PAS by Risk Management Plan (RMP) requirement
Institut pour la Recherche en Santé Publique (IReSP)
The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.
Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.
PAS by study status
Institut pour la Recherche en Santé Publique (IReSP)
The study status is defined according to the timeline dates specified.
Planned studies have not collected any data yet.
Ongoing studies collect data and should publish protocols as soon as possible.
Finalised studies should publish results in the first two weeks after finalisation.
Countries
Institut pour la Recherche en Santé Publique (IReSP)
1 Study countries specified are the following:
- France