Mann's Pharmacovigilance

Mann's Pharmacovigilance

Editor(s): Elizabeth B. Andrews, Nicholas Moore

Published Online: 4 APR 2014

Print ISBN: 9780470671047

Online ISBN: 9781118820186

DOI: 10.1002/9781118820186

About this Book

Highly Commended at the BMA Medical Book Awards 2015

Mann's Pharmacovigilance
is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics.

Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field.

From an international team of expert editors and contributors, Mann's Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine.

The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Table of contents

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  1. Part I: The Regulatory Basis of Pharmacovigilance

    1. Chapter 3

      Legal Basis: European Union (pages 25–35)

      Brian Edwards, Calvin Johnson and Shelley Gandhi

  2. Part II: Pharmacovigilance Systems - Pharmacovigilance in Europe

    1. Chapter 13f

      Pharmacovigilance in Spain (pages 217–220)

      Dolores Montero, Miguel Angel Maciá and César De La Fuente

  3. Part II: Pharmacovigilance Systems - Pharmacovigilance in the Americas

  4. Part II: Pharmacovigilance Systems - Pharmacovigilance in Asia

    1. Chapter 15d

      China (pages 267–269)

      Kenneth Hartigan-Go and Althea Bongat

    2. Chapter 15e

      Malaysia (pages 271–272)

      Kenneth Hartigan-Go and Althea Bongat

    3. Chapter 15g

      Singapore (pages 277–278)

      Kenneth Hartigan-Go and Althea Bongat

    4. Chapter 15h

      Thailand (pages 279–281)

      Kenneth Hartigan-Go and Althea Bongat

    5. Chapter 15i

      Vietnam (pages 283–284)

      Kenneth Hartigan-Go and Althea Bongat

  5. Part II: Pharmacovigilance Systems - Pharmacovigilance in New Zealand and Australia

    1. Chapter 16a

      Pharmacovigilance in New Zealand (pages 291–294)

      Mira Harrison-Woolrych, Michael Tatley and Desiree Kunac

  6. Part II: Pharmacovigilance Systems - Pharmacovigilance in Africa

  7. Part III: Signal Detection/Generation in Spontaneous Reporting Programs and Other Sources: From Spontaneous Reporting to Pharmacoepidemiology

  8. Part IV: Pharmacovigilance and Drug/System Organ Classes

  9. Part IV: Pharmacovigilance and Drug/System Organ Classes - Special Populations

  10. Part IV: Pharmacovigilance and Drug/System Organ Classes - Special Product Classes

    1. Chapter 44

      Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies (pages 685–702)

      John Acquavella, Brian Bradbury, Cathy Critchlow, J. Michael Sprafka, John Sullivan and Jason B. Litten

  11. Part V: Current Topics

  12. Part VI: Training and Education and Directions

    1. You have free access to this content
    1. You have free access to this content

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