Medical Product Regulatory Affairs - E-book

eBook

Medical Product Regulatory Affairs - ENG

Pharmaceuticals, Diagnostics, Medical Devices

John Tobin

eBook

$1,960.00

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Información adicional
Sinopsis

ISBN:	9783527623044
Formato:	Page Fidelity
Idioma:	Inglés
Editorial:	Wiley Global Research (STMS)
Tema:	Ciencia
Subtema:	Ciencias de la Vida biología celular
Año de publicación:	2008-09-08

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.

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