EMA to Launch New Version of EudraVigilance

On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2) format. Click here for the story, here for our most recent paper discussing the topic, or here to contact us for help with any pharmacovigilance issues you may have.

print