EudraVigilance, inspections and non-compliance: here is what to pay attention to

 

Back from the DIA Europe, which took place from 5th to 7th February 2019 in Vienna, we reported for you the intervention that most impressed us, since it warns about the risks that may occur during inspections.

Rory Littlebury, Pharmacovigilance Inspector of MHRA, told about the results of his inspection experiences during the session on pharmacovigilance “The new EudraVigilance system: one year later”.
From the implementation of the new EudraVigilance, two major anomalies were found: over-reporting and under-reporting.

The over-reporting is mainly attributable to the reporting of cases from literature articles related to a drug for which the company has not obtained the MA yet; to the submission of cases containing only the outcome and to the reporting of ICSR deriving from a secondary source.

The under-reporting is instead due to the non-submission of not-serious cases to EudraVigilance within the 90 days required by the regulations and to the trend to exclude the ownership of the drug for cases from literature.

Furthermore, from 22th November 2017, 20 GvP inspections were carried out by the MHRA, which revealed the following non-conformities by pharmaceutical companies:
– lack of documented procedures that describe the data monitoring processes in EudraVigilance
– lack of documented agreements that define the criteria and guidelines for the management of the revision of the eRMRs when outsourced to third parties
– lack of documentation confirming the quarterly revisions of the eRMRs or the implementation of the statements recorded during the monthly meetings of the Safety team.

To counterbalance the anomalies reported by the British inspector, the intervention of MSD UK’s Deputy EU QPPV, Margaret Walters, highlighted that the benefits expected from the new implementation of EudraVigilance, such as the simplification of the submission of cases and the signal detection, are, instead, undermined by the massive workload caused by the screening of the numerous cases downloaded. This led to a boost of time and resources employed, to the revision of internal procedures and to an even more complex handling of cases from literature, as well as to the increase of the duplicates.
In a third speech, Christiane Michel, Novartis Global Head Safety Signal Detection, illustrating the experience gained from the comparison between their internal database and EVDAS for the signal detection management, admitted that even for the Swiss multinational many are the difficulties and the challenges encountered.