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EudraVigilance training

The European Medicines Agency (EMA) has developed a modular training course to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance.

At least one user from each national competent authority, marketing-authorisation holder or sponsor of clinical trials in the European Economic Area (EEA) should complete the training to ensure the information collected in EudraVigilance is of the highest quality and integrity.

Users who have successfully completed the currently available EudraVigilance training courses and the subsequent registration process will be able to start the electronic submission of individual case safety reports (ICSRs) and ICSR acknowledgements to meet their reporting obligations in relation to pharmacovigilance or clinical trials authorised in the EEA.

Click on this link for more information.

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