The first edition of the European PharmacoVigilance Day took place on 30th November 2017 in Milan, an event of which we were the only sponsor, organized to talk about the ICH R3 news. There were numerous pharmaceutical companies that took the opportunity to clarify their doubts about the new management of pharmacovigilance. The topics of the speakers were: the procedural changes, the news of EudraVigilance and the importance of signal detection.
Here are the main issues provided in the 5 speeches:
1) With the transition from ICH E2B (R2) to ICH E2B (R3) the main innovations are: the introduction of nullflavor, the strengthening of data protection and privacy, the provision of a better tool for the competent authorities for the evaluation of the data quality provided by the MAH and by the sponsors.
The instructions for the search and management of the duplicates, described in GVP module VI, were taken into consideration, and a pragmatic cooperation approach was introduced between EMA and MAHs in order to eliminate duplicates from the Agency or MAH databases.
The Module IX of the GVP was revised to include some aspects connected with the monitoring of EudraVigilance as integral part of the signal detection processes of MAHs, using the Reporting Odds Ratio (ROR) as method of disproportionality.
Mr Marco Sardella, EU QPPV of ADIENNE Pharma & Biotech – “Complexity of Pharmacovigilance Management Today ”
2) Conversion from R3 to R2 is not recommended because some mandatory information in R2 is missing, while the upgrade from R2 to R3 requires verification of dosage conversions. In fact, while in R2 a drug corresponds to a single dosage, in R3 it can correspond to one or more dosages. The number of separate dosages in R3 has been removed.
Mr Calin Lungu, EMA trainer on EudraVigilance, XEVMPD and EVDAS – “New EVWEB / ISOICSR / XEVMPD”
3) Since the products of a company are linked to the headquarter, the affiliates cannot download the related cases, nor access EVDAS. Only the headquarter can access the data using its own account.
Mr Calin Lungu, EMA trainer on EudraVigilance, XEVMPD and EVDAS – “EVDAS and ICSR Download Manager”
4) It is important to continue to survey the medicinal product even after being marketed and not to stop the pharmacovigilance after the clinical trial phase. To do this it is essential to perform a signal detection based on both internal and regulatory databases (FDA AERS, PRAC Eudravigilance, WHO WHO Uppsala).
The cases increase due to the new system is to be considered an opportunity to make the sample for the detection of the signal even more consistent.
Dr Glyn Belcher EU QPPV and vice president of Biogen – “How to approach Signal Detection and Risk Management Today”
5) The MAHs will no longer provide ICSRs to the National Competent Authority, but only to EudraVigilance. The MAHs are required to include in Eudravigilance any report in their possession, with the exception of those which they become aware of through the National Authority.
The reports must be categorized by type: spontaneous, study, other information not available to the sender.
The routine requests for follow-up by the MAHs is not foreseen, except in specific cases and provided by a justification. These requests must be forwarded to the Local Pharmacovigilance Manager.
Prof. Ugo Moretti, head of the regional pharmacovigilance center of the Veneto region and the autonomous province of Bolzano – “From EudraVigilance to the National Network of Pharmacovigilance”