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Cobert's Manual of Drug Safety and Pharmacovigilance ReviewWorking 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 professionals who want to improve their working practices in the field.
Paul
PharmD.Cobert's Manual of Drug Safety and Pharmacovigilance OverviewCompletely 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.
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