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Pharmacovigilance Launch Readiness For Marketing Authorization Holders
Welcome back to the DDReg Knowledge Capsule! In this episode, we explore how Marketing Authorization Holders (MAHs) build and maintain compliant Pharmacovigilance (PV) governance structures as products transition to commercialization.We break down the core operational components of PV systems, including Qualified Person for Pharmacovigilance (QPPV) services, Individual Case Safety Report (ICSR) processing, literature monitoring, and signal managementWe also highlight how MAHs manage risk management strategies, aggregate safety reports, and audit and compliance controls to ensure ongoing…
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