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PVSentinel L2A Case Management

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Automate EMA E2B R3 File filter process for improved efficiency and compliance

Pharma companies are required to download E2B R3 files from the EV Web portal based on active substances (not based on the company’s products). Due this regulatory change, Pharmacovigilance operations at small to mid-size companies are challenged with timely completion of review and submission of huge volumes of ICSRs.  It is must for companies to include these ICSRs in the company’s centralized safety database to comply with other regulatory agencies for expedited reporting.

PVSentinel L2A Case Management

PVSentinel L2A Case Management is an E2B R3 File Filter to help companies automate the filtering process and designed specifically to address the efficiency and case volume management related to L2A cases. L2A Case Filter automatically reads the product information from the incoming E2B R3 files and compare it with existing configurations. PVSentinel L2A Case Management module has the capability to compare configurations defined in the drug safety system or with a custom defined list and filter out any files which are not related to the pharma company products. This module is highly configurable and provides a comprehensive activity log for future reference.

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Key Product Features

L2A Case Filter provides various, ready to use dashboards and reports to manage the process efficiently.

  • Dashboard for total cases processed in a specific time interval with details of success and non-success numbers
  • Total number of cases received for a country and processed based on report type
  • Multiple trend reports indicating total number of cases reported by time interval, source, product etc

PVSentinel L2A Case Filter directly reduces manual effort and address the regulatory compliance needs of the pharmacovigilance department.

How Do we Deliver

PVSentinel L2A Case Management is a component of our PVSentinel platform. It can be deployed on its own or in combination with other modules of the platform.

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