Good Pharmacovigilance Practice Guide

✍ Scribed by Medicines And Healthcare Products Regulatory Agency

Publisher: Pharmaceutical Pr
Year: 2008
Tongue: English
Leaves: 231
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

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 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.The MHRA has identified a need for writing and publishing a guide to "Good Pharmacovigilance Practice". This text complements current legislation and guidance, and provides practical advice about achieving an appropriate system of pharmacovigilance.

✦ Table of Contents

Cover......Page 1
Good Pharmacovigilance Practice Guide......Page 2
Contents......Page 6
Foreword......Page 13
Acknowledgements......Page 14
Introduction......Page 15
Abbreviations......Page 18
1. Qualified Person Responsible for Pharmacovigilance in the European Economic Area......Page 20
2. Management of Pharmacovigilance Data......Page 36
3. Spontaneous Case Processing......Page 48
4. Literature Searching......Page 68
5. Periodic Safety Update Reports......Page 80
6. Evaluation of Safety Data......Page 92
7. Risk Management Plans......Page 104
8. Reference Safety Information......Page 110
9. Quality Management System......Page 118
10. Interactions between Pharmacovigilance and Other Functions......Page 126
11. Contracts and Agreements......Page 138
12. Requirements for Solicited Reports......Page 146
ANNEX 1. Introduction to Pharmacovigilance
Inspections......Page 168
ANNEX 2. Relevant Legislation and Guidance......Page 178
ANNEX 3. UK Pharmacovigilance Offences......Page 182
ANNEX 4. Safety Reporting Requirements for
Clinical Studies......Page 193
ANNEX 5. Pharmacovigilance Initiatives......Page 206
Glossary......Page 208
Index......Page 218

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