European PSMF 2021 - The European PSMF Live Webinar
Topics/Call fo Papers
Under European post-marketing drug legislation it is a legal requirement to have a document produced – the Pharmacovigilance Systems Master File (PSMF).
This document covers the pharmacovigilance for all licensed products in the EU as well as any licences outside of the EU for the same product.
To understand the requirement of producing the PSMF and its maintenance The requirement to have this as an inspection ready document
The evolution of the PSMF and the legislation concerning it for the EU
Other PSMFs globally and linkage to other PSMFs
The sections of the PSMF
Speaker:
Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 17 years for PharSafer.
This document covers the pharmacovigilance for all licensed products in the EU as well as any licences outside of the EU for the same product.
To understand the requirement of producing the PSMF and its maintenance The requirement to have this as an inspection ready document
The evolution of the PSMF and the legislation concerning it for the EU
Other PSMFs globally and linkage to other PSMFs
The sections of the PSMF
Speaker:
Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 17 years for PharSafer.
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Last modified: 2021-04-17 13:38:16