DRAP Guidelines on National Pharmacovigilance System: PRAEC
The new article describes in detail the key aspects related to the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
The new article describes in detail the key aspects related to the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
The new article outlines the main stakeholders of the pharmacovigilance system and highlights the key points associated thereto.
The new article provides additional clarifications regarding the approaches to be followed when communicating important safety-related information and also outlines special risk minimization measures to be taken by the parties involved.
The new article highlights the key aspects related to the efforts the stakeholders should make in order to improve general awareness, and also explains the approach to be taken when it comes to training activities.
The new article provides further clarifications regarding the reporting requirements to be followed in order to ensure that critical information is communicated without undue delay.
The new article provides a detailed description of processes and procedures associated with signal management.
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