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The Pharmacovigilance System Master File: Business as Usual? Can This File Help Industry?

Track:
Clinical Safety and Pharmacovigilance

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
299B

Room Number:
4

Level:
Intermediate

Type:
Session

Title:
The Pharmacovigilance System Master File: Business as Usual? Can This File Help Industry?

Chair(s):
Niels Gronning, MSc
Management Consultant
NNIT, Denmark

Description:
Since the effective date of Module II of the Guidelines on Good Pharmacovigilance Practices (GVP) (July 2012), Marketing Authorization Holders (MAH) have struggled to ensure compliance with the new legislative measures for the EU. This session will review the comprehensiveness of the Pharmacovigilance System Master File (PSMF); in particular the requirements for organizational process and data oversight which continuously challenges MAH’s, and will provide insight into the industry/regulatory perspective of the PSMF and the inherent challenges associated with the implementation and enforcement of the legislation.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
The ABCs of the PSMF (Pharmacovigilance System Master File)
Doreen Lechner
Vice President
Telerx, United States

Implementation of the PSMF: IT and Organizational Considerations
Niels Gronning, MSc
Management Consultant
NNIT, Denmark

Industry/Regulator Perspective on PSMF
Shelley Gandhi
Director Pharmacovigilance and Drug Safety
NDA Group, Sweden