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.
Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar
Why Should You Attend
People should attend this training:
- To understand the requirement of producing the PSMF and its maintenance
- The requirement to have this as an inspection ready document
- The understanding of CAPA inclusions and removals
- The oversight of the PSMF and the involvement of the EU QP PV
- 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
Key Learning Objectives
- To understand the key elements of the main body of the PSMF
- Management of the Annexes with the PSMF
- Frequency of PSMF review
- Other PSMFs globally
- Review and approval of the PSMF
Who Will Benefit
The various Depts that will benefit from this training are:
- Newly appointed EU QP PVs
- Global Heads of PV
- Sales & Marketing
CEO PharSafer Associates Ltd - Global Leaders in Drug Safety
England, United Kingdom
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.
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.
Graeme is also a member of TOPRA; RQA and the Institute of Directors and has helped small start up Companies in their planning, growth and been involved in Company acquisitions, due diligence activities for product in-licensing and marketing and development strategies.
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