Course Overview

Colourful and dynamic, marvellous and interesting! Sound like pharmacovigilance to you? A face-to-face workshop with presentations, group discussion and case examples.

Why You Should Attend

Good Pharmacovigilance Practice and Good Manufacturing Practice Interface

The aim of this interactive one day workshop is to provide an introduction to Good Pharmacovigilance Practice (GVP) for those at the GMP/GVP interface such as those managing product quality complaints, supply/distribution chains and GMP quality systems as well as the contrasting role of the Qualified Person (QP) for pharmacovigilance. 

By The End Of This Workshop, You Will…

  • Be able to outline the key principles of GVP and have an overview of key European GVP legislation and guidance
  • Understand the links between the pharmacovigilance and GMP systems in a company
  • Have evaluated a typical pharmacovigilance system and be able to describe at least three aspects where GMP and GVP systems have critical interfaces
  • Have an awareness of, and have received information on, hot topics including electronic records, data integrity and the role of the QP for pharmacovigilance
  • Have discussed and received information on common GVP Inspection Findings

Who Would Benefit

  • Affiliate/country organizations QA and pharmacovigilance staff
  • GMP auditors, QPs, technical specialists (responsible for the management of product quality complaints, and/or distributors)
  • GVP and GMP managers wishing to gain an understanding of this GXP interface and current regulatory hot topics

Facilitated By

Louise Mawer is a GXP consultant, auditor and trainer. Working in the fields of GCP, GLP and GVP Louise brings color and enthusiasm to quality assurance. A former MHRA GCP and GLP Inspector, Louise has spent many years in quality assurance and remains highly motivated in these topics. 

Workshop Fees

Course cost (excluding VAT)  £695.00

DISCOUNTS AVAILABLE

Early bird and multiple delegate booking discounts available. Discounts also offered to NHS staff, regulators and charities - contact us for details.

Have a question or want to book a place? Contact pharmacourses@nsf.org - you can register online by clicking below. You may also be interested in the Good Clinical Practice workshop taking place the day before at the same location. 


 

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