Good Pharmacovigilance Practice Guide

Good Pharmacovigilance Practice Guide

  • Electronic book text

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This essential reference guide relates to pharmacovigilance of medicinal products for human use. It complements currently available EU legislation and guidance and provides practical advice to key stakeholders, in particular Marketing Authorisation Holders, about achieving an appropriate system of pharmacovigilance. 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. The Good Pharmacovigilance Practice Guide is the result of collaboration between different groups within the MHRA, including the GPvP Inspectorate, the Pharmacovigilance Group and the Clinical Trials Unit. By highlighting the areas in which inspection findings are commonly found and providing specific examples of good or poor practice, the guide can assist organisations in developing effective pharmacovigilance systems.
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Product details

  • Electronic book text | 232 pages
  • London, United Kingdom
  • 0853698759
  • 9780853698753

Review quote

'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 -- Michael R Jacobs * Doody's Notes * '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 -- Joshua J Gagne * The Annals of Pharmacotherapy *
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Table of contents

1. EEA Qualified Person Responsible for Pharmacovigilance; 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. Safety Reporting for Clinical Trials.
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