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Assessment of the European community system of pharmacovigilance

Final Report - Final Version. 25. January 2006
: Bührlen, B.; Reiß, T.; Beckmann, C.; Gassner, U.M.; Gleiter, C.H.

Fulltext urn:nbn:de:0011-n-499398 (1.5 MByte PDF)
MD5 Fingerprint: e79e3981d40c0743a8ddfebae549d654
Created on: 17.1.2008

Stuttgart: Fraunhofer IRB Verlag, 2006, 190 pp.
Reihe Innovationspotenziale
ISBN: 3-8167-7233-1
ISBN: 978-3-8167-7233-0
Book, Electronic Publication
Fraunhofer ISI ()
pharmacovigilance; safety of medicines; Europe; EMEA; national agency; EU system; regulation

Medicines have adverse effects, but sometimes these are only identified when the product is already in use. Pharmacovigiliance, i.e. the monitoring of the safety of medicines and taking action to reduce risk and increase benefit, is therefore of tremendous importance. In the project "Assessment of the European Community System of Pharmacovigilance", which was funded by the European Commission, it was empirically studied how well the national medicines agencies, the European Medicines Agency and marketing authorisation holders collaborate to improve the safety of medicines. The book presents the methods and results of the study. Recommendations are made for the further development of the system.