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, 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.Important The digital edition of this book is missing some of the images or content found in the physical edition.
Excellent introduction to the subject, various departments and functions in PV. I personally found it very interesting as a pharmacovigilance professional. It needs a revised edition in keeping with the recent regulatory changes. It would also be helpful if the U.S and ROW perspectives could be added in a newer edition.