Cobert's Manual Of Drug Safety And Pharmacovigilance

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.

Customer Reviews:

Long Overdue

By Paul Yoon - April 29, 2008

Working in Drug Safety for the past five years, I have waited for a book specific to the field. Previous understanding and knowledge was reduced to searching the CFR, reading ICH regulations, memorizing company SOP's, attending training presentations, etc. The book brings all the scattered pieces of information and regulations into a cohesive organization that allows it to be used as a comprehensive read or as a reference for drug safety information.

If read from chapter to chapter, the reader can bridge missing information, clarify ambiguous areas, and further understand Drug Safety. If used as a reference, all the pertinent facets of drug safety are presented, and appropriately indexed by concepts, which facilitates finding certain information or resource.

I'm pleased that someone took the initiative to write a long overdue drug safety book. I have already personally recommended to various colleagues, and I recommend it for other current or future... read more

A must have

By Henry Che - January 24, 2009

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People always ask me for training on Pharmacovigilance...especially IT folks wanting to "break into" the field. This is the book, folks. Spend the $75 or so and get a great overview of the field. Read this, then go ask intelligent questions. Trust me, I bought this even after working in the PV field for more than 10 years.

Cobert's Manual of Drug Safety and Pharmacovigilance

By Orest Hurko - March 4, 2013

Complete collection of government documents, so in that way useful and necessary. But precious little insight, commentary or analysis on the part of the author. But maybe that is just the nature of the beast.