Completely revised and updated, the Manual of Drug Safety and Pharmacovigilance, Second Edition is a how-to manual for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety (also known as pharmacovigilance) and side effects, as well as providing essential information on drug safety and regulations, including: recognizing, monitoring, reporting and cataloging serious adverse drug reactions.
The Manual of Drug Safety and Pharmacovigilance, Second Edition teaches the ins and outs of drug safety in the industry, hospitals, FDA, and other health agencies both in the US and around the world, and presents critical information about what is done when confronted with a drug safety problem.
"The book is very detailed. It defines drug safety and adverse drug events, and it is an excellent guide to the different regulatory agencies that oversee medication therapy in the United States and other countries. It provides information on medications from research and approval to post-marketing surveillance and ongoing monitoring. This manual is useful as a tool for education in pharmacy schools and as a resource for pharmacy quality management. It is the most comprehensive reference I have seen on pharmacovigilance."
-- Barbara Giacomelli, PharmD, MBA, FASHP (McKesson Provider Technologies) Doody's Review
"This book aims at drug safety and pharmacovigilance professionals, among which pharmaceutical and clinical research scientist, programmers, medical writers and technicians. It aims at (very) broad audience and tries to cover every ins and outs, both from a clinical, pharmacological and methodological perspective. If you indeed want a broad introduction on drug safety and are looking for an accessible, practical framework for the analysis and interpretation of drug safety data this book might be what you are looking for."
-- International Society of Pharmacovigilance
Written for both practitioners and students, the book is relevant for those in pharmacy, quality assurance, and nursing. The author is hoping to increase practitioners' knowledge and motivate them to improve drug safety.