Working towards "State-of-the-Art" within Pharmacovigilance
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Good Vigilance Practice Audits
The objective of a pharmacovigilance audit is to "verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
Audit PV is able to audit the pharmacovigilance system for companies globally against European, US-FDA and Asia-Pacific authority standards.
Mock Inspections & Inspection Readiness
As part of the audit offering Audit PV is also able to conduct Mock interview sessions and assisting in preparing companies for forthcoming inspection.
Full & Partial Pharmacovigilance System services
Audit PV has trained company employees and service providers globally through in-house training and conferences. The training provided can be tailored by the client from basic training on an annual basis of all company employees through to advanced training of pharmacovigilance departments in specific disciplines.
Quality Management System Consultation
Audit PV can work towards implementing or improving your pharmacovigilance quality management system to mirror the definitions accepted by the competent authority (defined as as a management system to direct and control an organisation with regard to quality).