Direction générale de l'Offre de soins (DGOS)
This sponsor has funded 3 studies across 1 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 13031 | Finalised | Not included in RMP | Alert generation using the case-population approach in the French claims databases (ALCAPONE) | Yes | Yes |
| 18568 | Finalised | Not included in RMP | Budget impact analysis of discontinuing Tyrosin Kinase Inhibitors in patients with chronic myeloid leukemia achieving a complete molecular response by... | Yes | Yes |
| 40492 | Ongoing | Not included in RMP | Impact of the COVID-19 pandemic on medical care: Analysis of medico-administrative data (COVID-HOSP) | No | No |
PAS by Risk Management Plan (RMP) requirement
Direction générale de l'Offre de soins (DGOS)
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
Direction générale de l'Offre de soins (DGOS)
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
Direction générale de l'Offre de soins (DGOS)
1 Study countries specified are the following:
- France