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Audits and Inspections in PV

Audits and inspections in PV are processes aimed at evaluating the compliance of a company or organization with regulatory requirements and industry standards for the management and reporting of adverse events associated with medical products.

Audits can be internal (conducted by the company itself) or external (conducted by regulatory agencies, such as the FDA or EMA), and typically involve a review of the company’s pharmacovigilance systemPVs, processes, and procedures to ensure that they meet the required standards and regulations.

Inspections, on the other hand, are typically conducted by regulatory agencies, and involve an on-site evaluation of the company’s facilities, systems, and documentation related to pharmacovigilance. Inspections are usually more comprehensive than audits and aim to verify compliance with regulations, as well as to identify any areas for improvement.

Both Audits and Inspections in PV play an important role in ensuring that companies and organizations have robust systems in place for managing and reporting adverse events, and that patients are protected by the safe and effective use of medical products.

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