Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices / Edition 1

Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices / Edition 1

by John J. Tobin, Gary Walsh
     
 

ISBN-10: 3527318771

ISBN-13: 9783527318773

Pub. Date: 09/16/2008

Publisher: Wiley

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

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Overview

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.

Product Details

ISBN-13:
9783527318773
Publisher:
Wiley
Publication date:
09/16/2008
Edition description:
New Edition
Pages:
297
Product dimensions:
6.80(w) x 9.60(h) x 0.80(d)

Table of Contents

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

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