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Title details for Medical Product Regulatory Affairs by John J. Tobin - Available

Medical Product Regulatory Affairs

by John J. Tobin
Gary Walsh
ebook
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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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Publisher: Wiley

Kindle Book

  • Release date: September 8, 2008

OverDrive Read

  • ISBN: 9783527644711
  • Release date: September 8, 2008

PDF ebook

  • ISBN: 9783527623044
  • File size: 10868 KB
  • Release date: September 8, 2008

Formats

Kindle Book
OverDrive Read
PDF ebook
Kindle restrictions

subjects

Science Nonfiction

Languages

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.
Expand title description text
Science Nonfiction