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Medical Product Regulatory Affairs

Original price was: د.إ683.00.Current price is: د.إ550.00.

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Description

Pages:
298
Language:
English
Format:
PDF
Size:
5 MB
ISBN-10:
9.78353E+12
ISBN-13:
978-3527318773
ASIN:
3527318771, B0063CWBQU

1st Edition

by John J. Tobin (Author), Gary Walsh (Author)

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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