Utrecht University (UU)
This sponsor has funded 4 studies across 31 countries.
| EU PAS ID | Status | RMP requirement | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|---|
| 45978 | Finalised | Not included in RMP | Review of studies evaluating the effectiveness of risk minimisation measures evaluated by PRAC (EffectiveRMM) | Yes | No |
| 47563 | Ongoing | Not included in RMP | Review of PRAC assessed PASS evaluating risk minimisation measures (RMM) (EffectiveRMM2) | No | No |
| 47825 | Ongoing | Not included in RMP | Impact of medicines regulatory interventions in Europe: a systematic review focusing on unintended consequences, data used and methodology | No | No |
| 105538 | Planned | Not included in RMP | The Impact of COVID-19 Pandemic on Drug Use: Implications for Regulatory Intervention Impact Studies | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Utrecht University (UU)
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
Utrecht University (UU)
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
Utrecht University (UU)
31 Study countries specified are the following:
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- United Kingdom