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Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

John J. Tobin, Gary Walsh




[PDF.hu54] Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

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 | #361427 in Books |  2008-09-02 | Original language:English | PDF # 1 |  9.80 x.85 x6.90l,1.55 | File type: PDF | 297 pages

||1 of 1 people found the following review helpful.| good book|By Luciano O. Ferreira|written in a technically precise and easy-going manner, it covers well all items listed in the index. Allocation of tables and pictures sometimes far from the page one is reading, but no harm done. Overall it is an excellent book to align a team of RA professionals with the basics of the area.

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.
Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketi...

You can specify the type of files you want, for your device.Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices   |  John J. Tobin, Gary Walsh.Not only was the story interesting, engaging and relatable, it also teaches lessons.

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