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The Pharmacovigilance System Master File: Business as Usual? Can This File Help Industry?
Session Chair(s)
Niels Gronning, MSC
Senior Specialist, Microsoft, Denmark
The ABCs of the PSMF (Pharmacovigilance System Master File)
Learning Objective : Identify the complexities associated with the establishment (conversion from DDPS) and maintenance of the PSMF from both the regulatory and industry perspective; Discuss how pharmaceutical companies may adapt their business processes and exploit their IT landscape to embrace the challenges related to the PSMF.
Speaker(s)
Doreen Lechner, PHD
Consultant, DWL Consulting, United States
The ABCs of the PSMF (Pharmacovigilance System Master File)
Niels Gronning, MSC
Senior Specialist, Microsoft, Denmark
Implementation of the PSMF: IT and Organizational Considerations
Shelley Gandhi, MS
Partner & PV trainer, Eliquent Life Sciences, United Kingdom
Industry/Regulator Perspective on PSMF
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