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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 5: Pharmacovigilance System Master File (PSMF) and Pharmacovigilance Quality Manual

Session Chair(s)

Yvonne Ditoro, BSN, MBA, RN

Yvonne Ditoro, BSN, MBA, RN

Pharmacovigilance Operations Consultant

Yvonne Ditoro and Associates LLC, United States

Overview and description of the Pharmacovigilance System Master File (PSMF) and the Pharmacovigilance Quality Manual
Review requirements, content, and maintenance for these documents

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