Medical Product Regulatory Affairs - Pharmaceuticals, Diagnostics, Medical Devices (Hardcover)

""This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing."" -Microbiology Today, May 2009

Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.

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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.

The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

General

Imprint:	Wiley-VCH Verlag GmbH
Country of origin:	Germany
Release date:	July 2008
First published:	September 2008
Authors:	J.J.Tobin
Dimensions:	245 x 175 x 18mm (L x W x T)
Format:	Hardcover
Pages:	283
ISBN-13:	978-3-527-31877-3
Categories:	Books > Law > Laws of other jurisdictions & general law > Social law > Public health & safety law Books > Medicine > General issues > Health systems & services > General Books > Medicine > Other branches of medicine > Pharmacology > General
LSN:	3-527-31877-1
Barcode:	9783527318773

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