Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

Nonfiction, Science & Nature, Science, Biological Sciences, Cytology
Cover of the book Medical Product Regulatory Affairs by John J. Tobin, Gary Walsh, Wiley
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Author: John J. Tobin, Gary Walsh ISBN: 9783527644711
Publisher: Wiley Publication: August 24, 2011
Imprint: Wiley-Blackwell Language: English
Author: John J. Tobin, Gary Walsh
ISBN: 9783527644711
Publisher: Wiley
Publication: August 24, 2011
Imprint: Wiley-Blackwell
Language: English

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.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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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