Programme Hospitalier de Recherche Clinique (PHRC)

This sponsor has funded 9 studies across 1 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
5356 Finalised Not included in RMP Veinotonics in pregnancy: a comparative study in the EFEMERIS database No No
5359 Finalised Not included in RMP Safety of influenza AH1N1 pandemic vaccination during pregnancy: a comparative study using the EFEMERIS database No No
5362 Finalised Not included in RMP Pregnancy outcome in women exposed to dopamine agonists during pregnancy: a study in EFEMERIS database No No
7994 Finalised Not included in RMP Asthma medication during pregnancy : a cohort study in EFEMERIS No No
8001 Finalised Not included in RMP How to classify women exposed to drug prescriptions during pregnancy in pharmaco-epidemiology studies? Method using treatment intensity and individual... No No
24699 Ongoing Not included in RMP Is low dose aspirin associated with a reduced risk of overall cancer among the French population (ASPIK) No No
26681 Finalised Not included in RMP A contemporary description of French newborns' growth using the Efemeris cohort No No
29177 Ongoing Not included in RMP Dual antiplatelet therapy for prolonged secondary prevention of acute coronary events (DEEPSPACE) No No
32748 Ongoing Not included in RMP Impact of cardiovascular comorbidities on the effectiveness of bevacizumab in elderly patients with metastatic colorectal cancer (IRAZU) No No

PAS by Risk Management Plan (RMP) requirement

Programme Hospitalier de Recherche Clinique (PHRC)

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.