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The Silver Lining of the PSMF: Flow Chart Displaying the Business and User Requirements

Time

Tue, Jun 17 7:15AM
T 37

Title

The Silver Lining of the PSMF: Flow Chart Displaying the Business and User Requirements

Abstract Summary

Method: Mapping, the information to be included in the PSMF per Module II in a flow chart, gives an overview to the European Medicines Agency (EMA), Competent Authorities (CA), Market Authorization Holders (MAHs) of the business and user requirement across functions within Pharma Industry.

Poster Presenter

Zsuzsanna Csutor
Director of Pharmacovigilance Services,
B&C Consulting AG
Switzerland