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Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

John J. Tobin , Gary Walsh

ISBN: 978-3-527-31877-3

Sep 2008, Wiley-Blackwell

297 pages

In Stock

$131.95

Description

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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What is a drug, and what is a device? Basic principles and definitions of healthcare products
The regulatory framework: FDA, EMEA, other regulatory authorities
The drug development process: pre-clinical and clinical studies
Medical devices: design control, validation, risk management
Regulatory submissions: forms and requirements
Quality systems: GMP, ISO norms, software validation
Post-marketing issues: surveillance, corrective and preventive actions
World harmonization of regulatory requirements
"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)