Ministère du Travail, de la Santé et des Solidarités
This sponsor has funded 4 studies across 1 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 31199 | Ongoing | Not included in RMP | Evaluation of the risks of biologic drugs exposure during pregnancy in patients with rheumatic chronic inflammatory diseases: data from the French... | No | No |
| 44456 | Ongoing | Not included in RMP | Impact of the COVID-19 epidemic on people with an inflammatory disease (COVIMID) | No | No |
| 44554 | Ongoing | Not included in RMP | Benefits of Pneumocystis jirovecii pneumonia prevention among patients with autoimmune or inflammatory disease treated with prolonged high dose... | No | No |
| 44570 | Ongoing | Not included in RMP | Safety evaluation of mid-urethral slings (SOFT) | No | No |
PAS by Risk Management Plan (RMP) requirement
Ministère du Travail, de la Santé et des Solidarités
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
Ministère du Travail, de la Santé et des Solidarités
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
Ministère du Travail, de la Santé et des Solidarités
1 Study countries specified are the following:
- France