Manual of Drug Safety And Pharmacovigilance

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 professionals who want to improve their working practices in the field.PaulPharmD.

.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.