Relativity in the Evaluation in Medicines Benefit-Risk Balance in Real Life
The subject matter covered in this Symposium has been the new EU Pharmacovigilance Directive which comes into force from July 2012.
The Directive introduces some fundamental changes at the EMA including an emphasis on demonstration of benefit-risk balance, a mandate from the EMA to request post marketing effectiveness studies, and the creation of the PRAC (Pharmacovigilance Risk Assessment Committee) who will advise the CHMP on these matters.
A senior panel of European and country agency speakers have been present to stimulate a robust debate. This event, organized by KATANA santé Agency, has met a huge success.
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