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Seaport Hotel

Aug 15, 2019 2:00 PM - Aug 16, 2019 10:45 PM

One Seaport Lane, Boston, MA 02210

The Pharmacovigilance Quality Management System

Learn how to design, develop, and manage a quality system related to your pharmacovigilance system.

Session 12: Risk-Based Auditing and the Pharmacovigilance Audit Universe

Session Chair(s)

Yvonne  Ditoro, BSN, MBA, RN

Yvonne Ditoro, BSN, MBA, RN

Pharmacovigilance Operations Consultant

Yvonne Ditoro and Associates LLC, United States

  • FDA and EMA requirements regarding Risk-Based Audits of the Pharmacovigilance System and Quality System
  • Recommendations on the design of the pharmacovigilance audit strategy
  • Identification of the pharmacovigilance processes and entities subject to pharmacovigilance audits (define the pharmacovigilance audit universe)
  • Development of risk assessment methodology
  • Implementation of the pharmacovigilance audit strategy plan
  • Methods of quality oversight and management of third parties performing pharmacovigilance activities

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