Mar 16, 2026

Why EudraVigilance Training Is a Compliance Requirement in Practice

EMA says it provides EudraVigilance training to support stakeholders in meeting their pharmacovigilance obligations and to ensure users understand system functions and submit high-quality data. EMA also states that at least one user per organisation should be trained and that, after successful completion, users can register with EudraVigilance.

That makes training more than an administrative step. It acts as a practical compliance control: if the people using the system are not properly trained, data quality and reporting reliability are at risk. EMA’s 2026 course materials reinforce this by focusing on E2B(R3), SUSAR handling, follow-up, amendment and nullification reporting, and EVWEB use.

In other words, competence is part of compliance. In pharmacovigilance, that is not a slogan. It is an operating principle.

Related Posts

Comments

0 Comments

Submit a Comment

Your email address will not be published. Required fields are marked *

Stay Ahead of Pharmacovigilance News

Subscribe to PV Watch Daily and get the latest drug safety updates, regulatory developments, safety signals, industry alerts, and expert insights delivered straight to your inbox.