ConcePTION

This sponsor has funded 9 studies across 20 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
43385 Ongoing Methods for controlling by indication for prescriptions: application to medications for neuropathic pain No No
43409 Planned Demonstrating solutions for studying intermittent medication exposures in diseases with episodic manifestations during pregnancy: application to... No No
43416 Ongoing Exposure to SSRI/SNRI and depression in pregnancy and long-term childhood outcomes: the effect of modifying factors Yes No
43420 Ongoing Novel statistics to handle rare diseases and small sample sizes using Bayesian techniques: Application to Multiple Sclerosis (MS) and Systemic Lupus... No No
45205 Ongoing Delineating a full phenotype of health, neurodevelopment and adaptive functioning in children and young adults with Fetal Valproate Spectrum Disorder. Yes No
46213 Ongoing Levocetirizine/cetirizine levels in human milk – an observational, clinical study among breastfeeding women No No
50142 Ongoing Data characterization of population-based data sources: ConcePTION pipeline Yes No
103385 Ongoing Prediction of venlafaxine exposure through breastfeeding Yes No
105190 Ongoing Transfer of metformin into human breast milk and the plasma of breastfeeding children - A low intervention trial with biobanking of breast milk and... No No

PAS by Risk Management Plan (RMP) requirement

ConcePTION

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.