CRISIS MANAGEMENT IN PHARMACOVIGILANCE

We provide crisis management services for the pharmacovigilance system.

In situations:

• when control over the PV system is lost,
• it is unclear in which direction to move in the development of the PV system,
• an audit system is assigned and the time for classic system setup is short

we will conduct a diagnostic for the PV system and develop a roadmap for overcoming the crisis.

We provide comprehensive support during audits and assist in the development of a robust CAPA plan.