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.
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
Sentinel L2A Case Filter directly reduces manual effort and address the regulatory compliance needs of the pharmacovigilance department.
How Do we Deliver
Sentinel L2A Case Management is a component of our Sentinel platform. It can be deployed on its own or in combination with other modules of the platform.