European PSMF 2021 - The European PSMF Live Webinar

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:
With a first degree in Biochemistry & Pharmacology and a PhD focussing on drug metabolism and Pharmacokinetics Graeme has worked in the areas of Drug Safety and Medical services for nearly the last 30 years.