Description
Book SynopsisPharmacovigilance 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. This text provides practical advice about achieving an appropriate system of pharmacovigilance.
Trade Review'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 *
'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 *
Table of Contents1. 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.
