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Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices

Author: John J Tobin, Dr.; Gary Walsh, (Biochemist)
Publisher: Weinheim : Wiley-Blackwell, ©2008.
Edition/Format:   Print book : EnglishView all editions and formats
Database:WorldCat
Summary:

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  Read more...

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Document Type: Book
All Authors / Contributors: John J Tobin, Dr.; Gary Walsh, (Biochemist)
ISBN: 9783527318773 3527318771
OCLC Number: 220010794
Description: xiii, 283 pages : illustrations ; 25 cm
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
Responsibility: by John J. Tobin and Gary Walsh.

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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 , Read more...

 
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