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Category Archives: Safety

Post approval Safety Information Reporting in 2012

'From' July 2012, new European wide legislation comes into effect whereby PharmaBio organizations that hold marketing authorizations for products in Europe will need to electronically report both serious and non-serious adverse reactions to one central point—EudraVigilance, the safety database of the European Medicines Agency (EMA), based in London. This is a major change, and requires organizations that carry out Pharmacovigilance to...
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