New Eudravigilance system was launched on November 22nd, 2017, and a prominent revision was made via transition of technical transmission of Individual Case Safety Reports (ICSRs) from ICH E2B (R2) to ICH E2B (R3) format. ICH E2B (R3) format proposed a new opportunity to gain greater insights into ICSRs and the benefit-risk profile of medicines due to the improved visibility of the data and the quality of ICSRs.
This upgrade, however, also introduced the industry to technical challenges which required detailed preparation and a lengthy planning to maintain regulatory compliance, as increasing countries come on-board. EMA, Japan, China and FDA are well on their way to the implementation. Countries such as South Korea have already mandated E2B(R2) XML but its movement towards E2B (R3) is not far enough.
Need of a smart EV triage solution in pharmacovigilance (PV) operations
After having an upgrade to E2B (R3), in PV operations now a days downloading and segregating E2B (R3) files from EVWEB is very much important task for every marketing authorization holder (MAH)/Sponsor but it has become a cumbersome task for any PV team to download multiple XML files at once and more difficult is their segregation into MAH or Non-MAH cases as per the presence of the company suspects products.
Basically, after downloading the R3-XML files, a MAH needs to separate the cases of its products from the cases of others which requires many manual hours and more no. of resources for reviewing.
Few more challenges include,
- Difficulties of reviewing R3 XML file as it is not a readable format
- Problems faced for keeping track of non-MAH, non-relevant/invalid cases with relevant reason for future analysis
Hence, there is a need of an efficient solution which automates the triage process of segregating and reconciling applicable cases from other non-relevant cases.
Sarjen’s PvD’code, a smart EV Triage solution is an efficient tool that automates the process of segregating and reconciling applicable cases from other non-relevant cases.
- Automates the process of triaging case activities
- Auto reads the EV XMLs and convert it in readable format (PDF)
- Marks a case as MAH/valid case and non MAH/invalid case by using Predefined algorithm case is automatically
- Given algorithm can be modified as per client’s SOP
- Provides auto duplicate check with some general conditions and helps users to take decision on marking it as duplicate case
- Sends out valid ICSR for further processing in the case processing module (auto import facility)
- Can be used with any PV system or E2B converter and leverages an intuitive user interface to significantly reduce the manual effort required to separate the cases relevant to the MAH.
Key Benefits includes…
- Offers full interoperability with any PV system or E2B converter of choice
- Tracking of non-MAH, invalid, and duplicate cases for future analysis and review
- Speeds case reconciliation
- Maximizes efficiencies of a pharmacovigilance (PV) team to focus on more critical tasks
- Deploys quickly as a cloud-based plug-in as well as on-premise