Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
Copyright © 2008 Wiley-VCH Verlag GmbH & Co. KGaA
Author(s): Dr. John J. Tobin, Prof. Dr. Gary Walsh
Published Online: 12 SEP 2008
Print ISBN: 9783527318773
Online ISBN: 9783527623037
About this Book
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 marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.
Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.