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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)
The ABCs of the PSMF (Pharmacovigilance System Master File)
Doreen Lechner, PhD
Rutgers University, United States
Program Director- Biopharma Educational Directive
Implementation of the PSMF: IT and Organizational Considerations
Niels Gronning, MSc
Microsoft, Denmark
Senior Specialist
Industry/Regulator Perspective on PSMF
Shelley Gandhi, MSc
NDA Group, United Kingdom
Strategic Advisor, Pharmacovigilance and Drug Safety
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