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This critical resource includes all the pharmaceutical and biologics chapters from RAPS’ four Fundamentals of Regulatory Affairs books, covering the US, EU, Canada, and international. This highly focused compilation looks in-depth at requirements throughout the product lifecycle, from R&D through postmarketing. It is an excellent guide to finding answers on pharmaceutical and biologics regulations, learning about the industry, and as a study tool for the RAC (Drug) Exam.
Here's what you get in the Fourth Edition:
To purchase both the hardcover and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Discount is only available when purchasing both versions in the same transaction.
Studying for the RAC? Take a look at our RAC prep resources. Important note: while the Fundamentals books contain information on Canadian regulations, there are no Canada-specific questions on the RAC exams.
Published by RAPS © 2021. Hardcover. Two Volumes. 1,524 pages. ISBN: 978-1-947493-69-8.