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Keys for adapting to the new Pharmacovigilance Environment

At the end of 2017, a new version of Eudravigilance went online to manage suspected adverse reactions to medicines.

This change requires all Marketing Authorisation Holders to adapt their pharmacovigilance management systems from ICH E2B(R2)/M2 to ISO/ICH E2B(R3), and to develop new software to integrate these improvements.

In order to operate effectively in this new format, it is essential:

  1. To have a database that is 100% operative in R3: The proper management of data not only ensures peace of mind during pharmacovigilance audits and inspections, but it is also a fundamental tool in optimising resources and procedures, facilitating the overall assessment of the safety of our medicines in a simple and efficient manner.
  1. To update the electronic notification systems for health authorities for receiving and sending cases of adverse reactions (Gateway): the databases must also comply with international laws and allow direct communication with the partners and/or collaborators of the health authorities, through the “Gateway” system. This is because cases are no longer communicated on a local level, but instead notified directly to the health authority through Eudravigilance.
  1. To migrate the electronic format of the cases correctly from R2 to R3: management software operating in R2 will become obsolete (the EMA currently permits R2 software to operate on a temporary basis through a converter). Therefore, it is necessary to adapt systems, which involves migrating cases to software in the R3 format to comply with Eudravigilance.
  1. To update signal detection: the new Eudravigilance gives all Marketing Authorisation Holders access to the EVDAS data analysis system, which means that there will be an unprecedented increase in the volume of data managed during the detection and management of signals. Therefore, it will be necessary to conduct an exhaustive analysis of the new data to integrate all of the obtained information. It will also be essential to conduct qualitative and quantitative assessment and to establish frequency analysis of identified adverse reactions during the period under study, which could involve a possible signal.


Pharmacovigilance Environment

In conclusion, with the launch of the latest version of Eudravigilance, a new Pharmacovigilance environment has emerged, which involves significant changes to guarantee regulatory compliance and effective Pharmacovigilance management on a day-to-day basis.

At Azierta, we are experts in Pharmacovigilance and 100% in alignment with the current European Pharmacovigilance environment. Our pharmacovigilance software “Vigilazierta” is now validated and fully functional in R3, and features a single module to migrate cases from R2 to R3, as well as a totally updated signal detection unit.

If you would like to find out more about us, or for further information, please visit our Vigilazierta website at:  https://azierta.eu/farmacovigilancia/vigilazierta/


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