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Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 14, 2019 4:00 PM

One Seaport Lane, Boston, MA 02210

Drug Safety and Pharmacovigilance Across the Product Lifecycle

Build a solid foundation in the key concepts of drug safety and pharmacovigilance throughout the medical product development lifecycle. Learn how to comply with regulatory requirements.

Session 17: Audits and Inspections, Pharmacovigilance System Master File (PSMF)

Session Chair(s)

Jill W. Buckley, PharmD

Jill W. Buckley, PharmD

Adjunct Assistant Professor

Rutgers, the State University of New Jersey, United States

This session will focus on PV inspection readiness, audits and inspections and observations/findings. In addition, a review of the format and content of a PSMF will be discussed.

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