Regulatory GVP Compliance Auditing
PharmaConsult will carry out an Audit of the Pharmacovigilance Management system and provide observations on the compliance with Good Vigilance Practice Regulations to prepare organisations for a Regulatory Authority Inspection.
Good Pharmacovigilance Practice compliance Audits comprise of:
- Collecting and managing data on the safety of medicines
- Looking at the data to detect ’signals’ (any new or changing safety issue)
- Evaluating the data and making decisions with regard to safety issues
- Acting to protect public health (including regulatory action)
- Communicating with stakeholders
- Audit, both of the outcomes of action taken and of the key processes involved.