Date :
Place : United States, East Camden
Website :https://worldcomplianceseminars.com/
Contact Person:WCs Conference
Description:
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. The document therefore covers pharmacovigilance that is global and not just confined to the EU. This document covers activities related to pharmacovigilance which include Regulatory; Clinical; IT; QA and the Marketing Dept. This document has also to be inspection ready and following the announcement of a Regulatory Inspection is the first document requested.Deadline for abstracts/proposals : 29th April 2021
Organized By :WOrldcomplianceseminars
Keynote Speakers : 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.
Conference Highlights :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 The annexes of the PSMF Audits and the PSMF including CAPAs Multiple Depts and their involvement with the PSMF Regulatory Inspections and the PSMF
Check the event website for more details.