Good Pharmacovigilance Practice Guide

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Good Pharmacovigilance Practice Guide

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Good Pharmacovigilance Practice Guide

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Medicines and Healthcare products Regulatory Agency
Published by
Pharmaceutical Press
Publication Date
November 2008
232 pages
172 x 244 mm

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

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