Quanticate has updated safety data management and global safety database to the latest version of Oracle Argus, v8,1.
According to the UK-based CRO, the investment anticipates the launch of an improved version of EudraVigilance – the European Medicines Agency’s (EMA) system for managing and analyzing information on suspected adverse reactions to medicines.
Compliant with Article 2(3) of Directive 2010/84/EU2, adverse reactions must be submitted electronically to the EudraVigilance database.
Per the EMA’s website, the new version of EudraVigilance “is fully functional and ready to go live on 22 November 2017.”
“The enhancement of EudraVigilance follows the revised EU legislation on pharmacovigilance, which updated the legal framework for reporting and analysing suspected adverse reactions to improve health protection,” according to the EMA.