European Enforcement of Pharmacovigilance and Inspection Trends. Is compliance possible within the EU? June 7, 2007 Dr. M.C. Koster CEO Vigilex Group. Europe. 27 EU member states (per 1 January 2007) 3 European EFTA countries have chosen to follow the EU legislation & guidance for PV
Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.
Is compliance possible within the EU?
June 7, 2007
Dr. M.C. Koster
CEO Vigilex Group
(Norway, Iceland and Liechtenstein)
as the EEA (European Economic Area)
“If the law supposes that,” said Mr. Bumble,… “the law is aass—an idiot. If that’s the eye of the law, the law is a bachelor; and the worst I wish the law is that his eye may be opened by experience.”
CHARLES DICKENS, Oliver Twist, chapter 51, p. 489
Outcome of inspections are not predictable as findings vary per country and per inspector