EudraVigilance Management.
Efficient, compliant, & tailored to your needs.

What is EudraVigilance Management?

EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is a data processing network and management system operated by the European Medicines Agency (EMA) on behalf of the European Union (EU) medicines regulatory network.

The system plays a vital role in managing and analysing information concerning suspected adverse reactions to medicines that have received authorization or are under investigation in clinical trials within the European Economic Area (EEA), allowing for the early detection and evaluation of potential safety signals, and enhanced product information for medicines authorized in the EEA.

It is supported by the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), which contains comprehensive information about all products in development or licensed within the EEA. Marketing Authorization Applicants (MAAs), Sponsors, and Marketing Authorization Holders (MAHs) are required to register in the system and maintain specific data.

Through EudraVigilance, Sponsors and MAHs, or those acting for them, can efficiently manage and submit Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) during clinical trials, the authorization period, or via data submission (art 57/ xEVMPD).

The system also supports the detection and monitoring of safety signals, safety data analysis, and reporting through the EudraVigilance Data Analysis System (EVDAS) interface.

As of June 30, 2022, reporting adverse effects to EudraVigilance in a data format based on international standards set by the International Organization for Standardization (ISO) is mandatory. This change is expected to enhance data quality and analytical capabilities within EudraVigilance significantly.

Click for information from EMA on EudraVigilance.

How can Aeigisana’s Pharmacovigilance team support you?

Our comprehensive EudraVigilance Management service extends beyond the establishment of your EudraVigilance account to provide a hands-on approach in the following areas to ensure that your clinical trial and marketed product reporting is fully compliant. We aim to empower you to focus on your core objectives while we take care of the intricate regulatory details. With our support, your EudraVigilance experience will be efficient, compliant, and tailored to your specific needs.

Account Creation and Management.

Our team specializes in setting up and maintaining your EudraVigilance account. We handle all the necessary paperwork, technical configurations, and administrative tasks, so you don’t have to worry about the intricacies of account management.

Organisation Data Updates.

As your organisation evolves, we’ll be there to make sure that your data within EudraVigilance stays current. Whether it’s changes in contact information, company structure, or affiliations, we’ll keep your records current.

Affiliate and Virtual Affiliate Management.

We understand the importance of managing your network effectively. We can create, maintain, and oversee your affiliates and virtual affiliates within EudraVigilance, ensuring they are interconnected and compliant.

User Management.

From user access rights to permissions, we handle the small yet important details of user management within EudraVigilance. This means you can focus on your core activities while we take care of user-related tasks.

Gateway Transmission Setup.

We simplify the process of establishing a secure gateway transmission to connect directly with the European Medicines Agency (EMA). Our expertise ensures that your data transmission is seamless and complies with all required standards.

Submission of ICSRs.

We can manage all of your Individual Case Safety Reports (ICSRs) submissions directly through EudraVigilance, using our safety database or your existing safety database.

EudraVigilance Setup Guidance.

Navigating the EudraVigilance setup process can be complex. We provide comprehensive guidance to steer you through each step, ensuring that you’re fully equipped to make the most of this vital regulatory safety tool.

Transfer of QPPV and/or Responsible Person Functions.

If you’re transitioning from previous providers, we manage the seamless transfer of Qualified Person for Pharmacovigilance (QPPV) and Responsible Person functions, ensuring continuity in your operations.