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Reviewed by Meenakshi Bhatt for Readers' Favorite
Pharmaceutical Regulatory Affairs: An Introduction for Life Scientists by Dr. CF Harrison is a detailed guide for those who want to build a career in that field. The author begins by describing what regulatory affairs involve. He explains the variety of responsibilities that someone in that profession will have to shoulder and the skills that will be needed. He lists and describes the diverse sectors in which a regulatory affairs manager can work. Finally, he gets down to the nitty-gritty of preparing a dossier and outlines the process of applying for approval of a drug or a device to the regulatory authorities of various countries.
Pharmaceutical Regulatory Affairs is a concise book on the subject. It is short and yet packed with information. Dr. CF Harrison clearly describes the challenges of the job and the extreme ebb and flow of the work. At certain stages of drug approval, the days are long and the breaks are few. He provides the reader with a clear view of the kind of challenges they might face if they choose this career. The book also offers a brief but fascinating glimpse into the world of drug development. Despite the subject matter, the book is anything but dry. Harrison peppers the serious stuff with bits of humor (the description of the product information leaflet is a case in point). Reading the book feels like listening to an informative lecture by your favorite professor. The book is useful not only for those who are looking to enter the field but also for established beginners who can use it as a reference.