Federal Office of Public Health (FOPH)
This sponsor has funded 1 studies across 19 countries.
| EU PAS ID | Status | Title | Protocol uploaded | Results uploaded |
|---|---|---|---|---|
| 39226 | Finalised | Registry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study) (COVI-PREG) | Yes | No |
PAS by Risk Management Plan (RMP) requirement
Federal Office of Public Health (FOPH)
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
Federal Office of Public Health (FOPH)
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
Federal Office of Public Health (FOPH)
19 Study countries specified are the following:
- Argentina
- Belgium
- Brazil
- Chile
- Colombia
- Egypt
- France
- French Guiana
- Germany
- Ireland
- Israel
- Italy
- Mexico
- Peru
- Portugal
- Spain
- Switzerland
- United Kingdom
- United States