EMA Explains How To Comply With Future EudraVigilance Reporting Requirements
This article was originally published in SRA
Executive Summary
The European Medicines Agency has issued a document explaining the changes that drug companies will need to make to their internal processes in the near future to allow them to carry out various pharmacovigilance-related tasks, such as reporting of drug side-effects and conducting signal management, when the EudraVigilance database is updated in 20171,2.