Medical Product Regulatory Affairs  -  John J. Tobin

Pharmaceuticals, Diagnostics, Medical Devices

KORTE INHOUD

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 pr...
2008 Taal: Engels zie alle details...

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2008 Uitgever: John Wiley & Sons 297 paginas Taal: Engels ISBN-10: 3527318771 ISBN-13: 9783527318773