title: Data exchange in the European pharmacovigilance.
abstract: Recent research work on feasible solutions for electronic data exchanges in the european pharmacovigilance domain (EPhV) has facilitated a better understanding on strategic and operational factors inherent to such a class of transnational vigilance information systems. Most of the material presented here has resulted from the CARE-Pharmacovigilance Pilot project of the ENS-Telematics Programme, and from other subsequent research activities like the IDA feasibility study and the TEDIS-EuroSCape project. Attention has been paid to design principles and features of a communication scheme that must be used to support cooperative problem solving within a network of loosely connected autonomous and hetereogeneous agents. Experience confirmed two key-success factors: a) the users leading role, and b) the Pilot approach putting the focus on standardized electronic data interchange for communicating existing different local systems.
authors.affiliation: Institute of Health Carlos III, Health Services Research Unit, Madrid, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Monteagudo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D003195:Computer Communication Networks; D003199:Computer Systems; D005060:Europe; D007256:Information Systems; D010865:Pilot Projects