European Federation of Pharmaceutical Industries and Associations (EFPIA)

This sponsor has funded 5 studies across 10 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
11157 Finalised Not included in RMP Identification of type 2 diabetes cases in a set of databases participating to the EMIF project Yes No
14060 Ongoing Not included in RMP Estimating prevalence and incidence of acute myocardial infarction in a set of heterogeneous sources of observational health data collaborating in the... Yes No
24458 Ongoing Not included in RMP EMIF Use Case 17 - Investigating the relationship in paediatric population between dosing of antibiotics (prescribed, dispensed or administered) and... Yes No
43409 Planned Not included in RMP Demonstrating solutions for studying intermittent medication exposures in diseases with episodic manifestations during pregnancy: application to... No No
44505 Planned Not included in RMP Demonstration study 2.5.5 of the ConcePTION project; Validation of primary source pregnancy exposure and outcomes (pharmacovigilance data) No No

PAS by Risk Management Plan (RMP) requirement

European Federation of Pharmaceutical Industries and Associations (EFPIA)

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.