Pharmacovigilance
Pharmacovigilance system master file
The master file that describes your safety system as it really runs.
Related services
Qualified person for pharmacovigilance (QPPV)
A qualified person responsible for the safety of your products in Kenya, with a named deputy, available to the regulator.
Adverse event reporting
Receiving, assessing and reporting adverse events to the Pharmacy and Poisons Board on time.
Periodic safety reports
Periodic safety update reports written, reviewed and submitted on schedule.
Safety signal management
Detection, validation and follow-through with documented decisions.
Medical literature monitoring
Global and local medical literature checked for safety information and logged.
Risk management plans
RMPs and risk minimisation measures adapted to local practice.