Pharmacovigilance

Pharmacovigilance Transformation: Better Reporting, Reduced Costs

The pharmacovigilance (PV) team at a large, global biopharma company faced a challenging operational environment. Plagued with a host of disconnected systems, their day-to-day operation weighed them down with a…

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Change ahead: New E2B(R3) guideline for case safety reports

Latest revision of ICH guideline updates required data elements for transmission of Individual Case Safety Reports (ICSRs)