Journal
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
Volume 64, Issue 8, Pages 743-752Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00228-008-0475-9
Keywords
drug regulation; drug safety; intensive monitoring; pharmacovigilance; spontaneous reporting; transparency
Categories
Ask authors/readers for more resources
Background Pharmacovigilance, defined by the World Health Organisation as 'the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem' plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug's adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes, both at a regulatory and a scientific level, are being developed with the aim of strengthening pharmacovigilance. On a regulatory level, these include conditional approval and risk management plans; on a scientific level, transparency and increased patient involvement are two important elements. Objective To review and discuss various aspects of pharmacovigilance, including new methodolgical developments.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available