Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers
A. O. Lovkova,
S. M. Gyulakhmedova,
A. A. Druzhinina
et al.
Abstract:Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance documents, particularly the risk management plan (RMP). In practice, the changed EAEU GVP has resulted in multiple errors, creating the need to thoroughly analyse their structure and causes and to develop recommendations for their prevention.Aim. This study aimed to identi… Show more
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