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DDReg Knowledge Capsule · October 1 · 22 min

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 patient safety and fulfill regulatory obligations post-approval.Finally, we outline how PV teams work alongside Regulatory Affairs to update regulatory authorities and maintain accurate product documentation. Visit our blog for more information - https://resource.ddregpharma.com/blogs/global-to-local-pharmacovigilance-governance/

0:00-22:45
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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 patient safety and fulfill regulatory obligations post-approval.Finally, we outline how PV teams work alongside Regulatory Affairs to update regulatory authorities and maintain accurate product documentation.

Visit our blog for more information - https://resource.ddregpharma.com/blogs/global-to-local-pharmacovigilance-governance/

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