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Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

Medical Product Regulatory Affairs by John J. Tobin
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US$ 123.95
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Written in a clear and concise style by an experienced author, thisattractively-priced book covers regulatory affairs in all majorglobal markets for pharmaceuticals and medical devices, making itthe most comprehensive in its field.
Following a look at drug development, complete sections are devotedto national and EU regulatory issues, manufacturing licenseapplication and retention, and regulation in the USA. Other topicsdealt with include CDER, CBER and marketing and manufacturinglicenses, the ICH process and GoodLaboratory/Clinical/Manufacturing Practices.
Everything pharmacologists, bioengineers, pharma engineers,students in pharmacy and those working in the pharmaceuticalindustry need to know about medical regulatory affairs.
Wiley; September 2008
297 pages; ISBN 9783527644711
Read online, or download in secure EPUB or secure PDF format
Title: Medical Product Regulatory Affairs
Author: John J. Tobin; Gary Walsh
 
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