Good Pharmacovigilance Practice Guide

• 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.

'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