We comprehensively manage the pharmacovigilance system – from receiving reports and analyses to cooperation with URPL and Eudravigilance.
Our pharmacovigilance services include implementation of client products into PharmConsult’s own system and full management of pharmacovigilance activities, including:
QPPV service
Preparation of Periodic Safety Update Reports (PSUR) with clinical expert reports
Preparation of Risk Management Plans (RMP)
Preparation of summaries describing adverse event monitoring systems
Development of required procedures and instructions
Personnel training – initial and periodic
Maintaining adverse event registries
Signal detection
Receiving adverse event reports from various sources, classification, and causality assessment
Literature review
Management of the EudraVigilance system (including XEVMPD)
Development of local versions of risk minimisation measures (RMMs)
We also offer the service of a local qualified person responsible for pharmacovigilance (LQPPV), whose activities include:
Training locally employed personnel for the marketing authorization holder – initial and periodic
Maintaining adverse event registries
Signal detection
Receiving adverse event reports from various sources and transferring detected signals to the QPPV
Literature review
Cooperation with the Office for Registration on behalf of the marketing authorization holder
Preparation of local versions of risk minimization measures, assessment of materials, conducting the approval procedure by URPLWMiPB, and their implementation
