Good Pharmacovigilance Practice Guide

This essential reference guide covers pharmacovigilance of medicinal products for human use. The Good Pharmacovigilance Practice Guide highlights the areas in which inspection findings are commonly found and provides specific examples of good or poor practice. This assists organisations in developing effective pharmacovigilance systems.

This book complements EU legislation and guidance and provides practical advice about achieving an appropriate system of pharmacovigilance. It was primarily developed for UK Marketing Authorisation Holders (MAHs). It will also be of great interest to pharmacovigilance consultants.

Contents include:

• roles and responsibilities of the EEA Qualified Person for Pharmacovigilance
• managing case reports and other safety information
• ongoing evaluation of safety data
• quality management aspects of pharmacovigilance
• managing contracts and agreements
• pharmacovigilance beyond the drug safety department.

Commercial pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines. This is collected with a view to identifying new information about hazards associated with medicines and preventing harm to patients. Pharmacovigilance is particularly concerned with adverse drug reactions.

Good Pharmacovigilance Practice Guide is also available as an eBook.

1. Qualified Person Responsible for Pharmacovigilance in the European Economic Area
2. Management of Pharmacovigilance Data
3. Spontaneous Case Processing
4. Literature Searching
5. Periodic Safety Update Reports
6. Evaluation of Safety Data
7. Risk Management Plans
8. Reference Safety Information
9. Quality Management System
10. Interactions Between Pharmacovigilance and Other Functions
11. Contracts and Agreements
12. Requirements for Solicited Reports

Annexes:
1. Introduction to pharmacovigilance inspections
2. Relevant legislation and guidance
3. UK pharmacovigilance offences
4. Safety reporting requirements for clinical studies
5. Pharmacovigilance initiatives

 Sample chapter (107 KB)

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01-May-09, The Annals of Pharmacotherapy
'This is an easy-to-read, practical guide that navigates relevant pharmacovigilance legislation and guidance. It is a valuable single reference for an array of information.'
Joshua J Gagne PharmD MS, The Annals of Pharmacotherapy, Volume 43, May 2009

27-Feb-09, Doody's Notes
'This book provides valuable insight to the agency's (MHRA) expectations. Those whose primary role lies outside the area of pharmacovigilance are very likely to benefit from the book because it should help them to better understand the commitments the organization is making to maximise product safety.'
Michael R Jacobs, BS PharmD, Doody's Notes, 27th February 2009

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