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

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation covers topics such as:

  • Design of the PV audit strategy
  • EMA and FDA requirements regarding Risk Based audits
  • Strategic level audit planning
  • Identification of the PV processes and entities subject to PV audit
  • Safety data exchange agreements (SDEAs) and vendor contracts
  • Risk assessment criteria
  • Risk assessments
  • Categorization of the entities (PV Audit Universe)
  • 3-5 year PV audit plan
  • Prioritization of entities for audit according to relative risk
  • Identify procedures/tools to monitor PV quality for oversight of third parties
  • Procedural documents, e.g. SOPs

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation brings together:

  • PV Compliance professionals
  • PV Quality Assurance Staff
  • Pharmacovigilance Auditors
  • Quality auditors
  • PV Service Provider Relationship Managers
  • Relevant Pharmacovigilance Staff
  • MAH Affiliates responsible for Pharmacovigilance

Future Events

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation 2020

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