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. 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 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; pharmacovigilan
