Pharmacovigilance Audit and Inspections US MasterClass

The training will explore the key aspects of the pharmacovigilance audits (PV Audits), from planning audit programmes, conducting audits to delivering audit findings through audit reports. The impact of the pv legislation and GVP will be addressed and guidance will be provided.

13 - 15 September, 2022, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

This online masterclass will explore the key aspects of the pharmacovigilance audits, from planning audit programmes, conducting audits to delivering audit findings through audit reports. The impact of the pharmacovigilance legislation and GVP will be addressed and guidance will be provided on auditing PV systems both at a global and at a local organisation levels, including outsourced activities.

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RECOMMENDATION

Who should attend?

• Pharmacovigilance Auditors

• Potential PV Auditors

• PV personnel

• Vendors of Pharma Companies

• Medical Information staff

• Marketing people involved in actvities with patients.

• QPPVs

• Responsibles for Computer Systems

• Clinical Operations staff

• Medical Affairs staff