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Good Pharmacovigilance Practice Guide

First edition


Medicines and Healthcare products Regulatory Agency

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.

Good Pharmacovigilance Practice Guide

£37.00


RPS MEMBER PRICE £27.75

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