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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.

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Session 9: Pharmacovigilance Agreements (PVAs) and PV Provisions

Session Chair(s)

Yvonne Ditoro, BSN, MBA, RN

Yvonne Ditoro, BSN, MBA, RN

Pharmacovigilance Operations Consultant

Yvonne Ditoro and Associates LLC, United States

  • Various relationships requiring a PVA (also known as Safety Data Exchange Agreement) or PV provisions and the types of contracts
  • Development of PVAs across clinical study programs and post-marketing, including regulatory requirements, updating, quality oversight, operational aspects, and best practices

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