Audit in the area of the pharmacovigilance system is the responsibility of Marketing Authorization Holder.

Pursuant to Directive 2001/83 / EC Art 101 (2), Art 104 (2), Regulation No 726/2004 Art 28f and the guidelines of Good Pharmacovigilance Practice (GVP), audits should be carried out regularly in accordance with the prepared audit plan and based on the risk analysis. Regulation (EU) No 520/2012 Art 13 (1), Art 17 (1).

The consultants / auditors possess years of experience in conducting pharmacovigilance audits. They have a unique combination of knowledge in the field of pharmacovigilance with the knowledge of audits performance obtained during the trainings organized by MHRA, DIA, ISOP, BARQA and during the postgraduate studies in "Quality Manager" completed with an auditor's certificate issued by the Bureau Veritas (certification body) and the University of Business.