Safety Data Exchange Agreement (SDEA)

An Automated Safety Data Exchange Agreement (SDEA) System to manage legal written contractual agreement between two or more parties that ensures that all necessary information on the safety of medicine reaches the marketing authorization holder (MAH) quickly and safely so that he/she can fulfil his legal obligations on time. SDEA defines each party’s responsibilities in pharmacovigilance activities, and it prevents the duplication of activities between different partners. Marketing authorization holders should sign these agreements with partners to be in full regulatory compliance.

PvEdge helps in order to prepare a Safety Data Exchange Agreement (SDEA), all aspects of proper and reliable cooperation in the view of pharmacovigilance obligations between the responsible parties should be considered and documented.

It ensures full regulatory compliance and helps to fulfil pharmacovigilance obligations by preventing the duplication of pharmacovigilance activities by various partners.