In 2017, EMA has updated the EudraVigilance system, providing MAHs with wider access to relevant ICSRs accompanied by an obligation to monitor these cases with a frequency proportionate to the identified risk. This, combined with a change in E2B R3 format for transmission of ICSRs, increased the complexity of analysis, and resulted in a significant increase in the effort required to fulfill these obligations.
MAHs are today committed to download and import ICSRs from EudraVigilance, segregating the company relevant cases, excluding cases from other MAHs and duplicate cases already existing in the company safety database.
With increasing amount of data placing high demand on Pharmacovigilance system, more efficient EVWEB / MLM download processes are required; to answer this need, we offer a tool called SMARTVIGISCREEN, an easy to use EVWEB download (L2A) and MLM screening related solution for pharmacovigilance. SMARTVIGISCREEN is a cloud-based software solution that processes incoming ICSRs automating the analysis of company vs non-company cases and taking away manual efforts. The tool is GxP validated system according to GAMP 5 guidelines and CFR Title 21 Part 11 compliant.
Moreover, SMARTVIGISCREEN is fully validated for both EVW and MLM download process and can easily be integrated with ICSR Management process, generating up to 70% efficiency increase.
Director Pharmacovigilance, PharmaLex
With over 15 years of experience in pharmaceutical and pharmacovigilance outsourcing service industry, Mukund brings a thorough understanding of the pharmacovigilance process, it´s regulatory landscape and requirements. He leads the Pharmacovigilance Operations and Delivery of PharmaLex; his modus operandi includes combining domain expertise with strategic thinking as well as a holistic approach to business growth and implementation of transformational solutions and new initiatives.
Over the last few years, Mukund has been exploring digital technologies as enablers to address the needs of Pharmacovigilance operations, which can potentially bring in process efficiencies and add value to the system by reducing the efforts and associated cost.