On the last day of your EudraVigilance training course on Electronic Reporting of ICSRs in the EEA, you are invited to take part in the EudraVigilance Competency Assessment.

In order to receive the Certificate of Completion which is necessary to register as a user in the production site of EudraVigilance, it is mandatory to pass all three sections of the assessment.

A minimum score of 80% is necessary to pass. You have three attempts to pass each section of the assessment.

Kindly note that the credentials (password and username) that you are given on the first day of your training course are valid for 60 days and allow access to the EudraVigilance training environment only.

The EudraVigilance Competency Assessment are composed of these three sections:

Section 1 – Multiple Choice
This section consists of 31 randomly selected multiple-choice questions. There is one correct answer for each question

Section 2 – ICSR Exam Case
In this section, you are required to enter data of a mock CIOMS form into the EVWEB tool.

Section 3: Product Report Exam Case
In this section, you are required to enter data of a mock medicinal product into the EVWEB tool.

The DIA will send you an email with your scores and will mail successful candidates the Certificate of Completion by regular mail. Kindly note that the process of evaluating your assessment might take up to several weeks.

In case you do not obtain a passing score on your first attempt, the DIA will forward you the link with further instructions for the second and/or third attempt of the section that you did not pass. You will receive an email with your scores by the DIA. The process of evaluating your retake might take up to several weeks.