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2021 - PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

Date2021-03-18 - 2021-03-19


VenueVirtual Seminar, USA - United States USA - United States

KeywordsPharmacovigilance audit plan; Fda pharmacovigilance audits; Pv audit strategy plan


Topics/Call fo Papers

Develop a high-level PV audit strategy
Identify the PV activities and processes subject to PV audit
Develop risk assessment criteria
Identify the PV audit universe – entities subject to PV audit
Categorize the entities subject to PV audit
Perform risk assessments
Prioritize entities for audit according to relative risk
Prepare a 3-5 year PV audit plan
Identify procedures/tools to monitor PV quality of third parties

Last modified: 2021-02-12 16:43:07