 ActioMed has extensive experience in audits of the Pharmacovigilance system based on inspections by the Health Authorities and the qualifications of professionals in the field of pharmacovigilance and management of Quality Systems.
Both Good Pharmacovigilance Practices and existing legislation provide the need to conduct regular audits of the pharmacovigilance system.
The results of the audit provide an objective view of the implementation and maintenance of the System.
What ActioMed offers pharmaceutical industry:
- Internal audits of pharmacovigilance system, evaluating the current situation, identifying areas for improvement and advising the implementation and monitoring corrective actions.
- Support and expert advice on inspections of the Health Authorities, working through the process (preparation, implementation and monitoring). "Mock inspections".
- External audits of pharmacovigilance to affiliates and partners CROs.
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