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Seaport Hotel

2019 年 08 月 15 日 2:00 下午 - 2019 年 08 月 16 日 10:45 下午

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 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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