Spark Therapeutics

This sponsor has funded 1 studies across 20 countries.

PAS funded by this sponsor.
EU PAS ID Status Title Protocol uploaded Results uploaded
48683 Planned No No

PAS by Risk Management Plan (RMP) requirement

Spark Therapeutics

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.