As of November 2017, the European Medicines Agency launched a new and enhanced version of Eudravigilance.
Eudravigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). CROS NT looks at some considerations for the enhanced system and why companies should consider a pharmacovigilance outsourcing strategy for case collection, data entry and reporting in Europe.
How can companies prepare for these changes, such as Individual Case Safety Report (ICSR) electronic submission and the EU portal for adverse reactions?
Pharmacovigilance Outsourcing (PVO) is certainly on the rise as companies now need niche and specialized providers for these services. Companies can turn to a Functional Service Provision model without having to build an internal pharmacovigilance department. Implementing this model allows Sponsors to have access to experts in pharmacovigilance and Eudravigilance reporting at variable costing depending on the workload. Sponsors can also turn to the FSP model for other PhV tasks such as case collection and data entry.
Companies should ask their PhV provider if they have an EU QPPV on staff as well as Eudravigilance qualified personnel.