The cornerstone product for the regulatory affairs industry, this book is used as an essential training tool at many prominent healthcare organizations, a mandatory text in many university-level courses and the most popular reference tool in preparing for the RAC (US) Exam. The new edition has been.
I've been in RA for over 10 years and involved 510(k) submissions,Technical File creation and maintenance and the point person for all FDA/ISO/CE/CMDCAS audits.
I was looking at purchasing Fundamentals of US Regulatory Affairs, Seventh Edition and Fundamentals of International Regulatory Affairs, First Edition from the RAPS website as a way to expand my knowledge (not, at this time, to prep for the RAC exams).
I'm wondering though if these books will have any value to someone with lots of experience or if they are geared toward newcomers to the field?
Thanks.
I was looking at purchasing Fundamentals of US Regulatory Affairs, Seventh Edition and Fundamentals of International Regulatory Affairs, First Edition from the RAPS website as a way to expand my knowledge (not, at this time, to prep for the RAC exams).
I'm wondering though if these books will have any value to someone with lots of experience or if they are geared toward newcomers to the field?
Thanks.
Fundamentals of US Regulatory Affairs, Eighth Edition Paperback – 2013
Author: RAPS ID: 0982932065
Very Good Condition. Used text for one semester in clinical research program and it was brand new when I purchased it. Some highlighting and underlining (shown in photos). Great price compared to other sites!!
Paperback: 540 pagesPublisher: Regulatory Affairs Professionals Society; 8th edition (2013)Language: EnglishISBN-10: 0982932065ISBN-13: 978-0982932063 Product Dimensions: 10.9 x 8.5 x 1.1 inches Shipping Weight: 2.8 pounds Best Sellers Rank: #1,195,247 in Books (See Top 100 in Books) #387 in Books > Medical Books > Medicine > Reference > Drug Guides #896 in Books > Engineering & Transportation > Engineering > Bioengineering > Biotechnology #1295 in Books > Engineering & Transportation > Engineering > Bioengineering > Biochemistry
Good cure for insomnia. Lots of good info though and I love the back sections of the book that have handy 'cheat sheets' for RA professionals.
![Raps Raps](/uploads/1/2/6/2/126259011/775433945.jpg)
For the price they charge for textbooks, I would have hoped this was at least available in a hardcover format. However I agree with the other reviewer: Good cure for insomnia.
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Download Fundamentals of US Regulatory Affairs, Eighth Edition – 2013 Pdf Download
Download Fundamentals of US Regulatory Affairs, Eighth Edition – 2013 Pdf Download
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