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Tobin, John J.

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Tobin, John J. - Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices, ebook

89,30€

Ebook, ePUB with Adobe DRM
ISBN: 9783527644711
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Printing89 pages with an additional page accrued every 9 hours, capped at 89 pages
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"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.

Keywords: Cell & Molecular Biology

Author(s)
 
Publisher
John Wiley and Sons, Inc.
Publication year
2011
Language
en
Edition
1
Page amount
297 pages
Category
Natural Sciences
Format
Ebook
eISBN (ePUB)
9783527644711
Printed ISBN
9783527318773

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