Audit of Pharmacovigilance Compliance

The scope of pharmacovigilance is the total safety set-up - HQ, local operating companies, and contributing parties. 

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A PV system must be transparent, focused, and understandable for its users. The structure must capture the relevant information and provide clear and timely solutions throughout the organization. 

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The global safety set-up must be robust, consistent, and compliant throughout, whether viewed from the local or central perspective.

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Auditing of the safety set-up should be covered by a strategic plan and be done on a regular basis both of central functions and  the safety set up at affiliates. Drug Safety Consult does  PV auditing and compliance assessments towards current legislation, EMA Pharmacovigilance modules, ICH guidelines, and applicable local legislation.

Contact Drug Safety Consult if you are in need of PV audits  or need a PV quality plan for the company.



Contact  here.