Error loading page.
Try refreshing the page. If that doesn't work, there may be a network issue, and you can use our self test page to see what's preventing the page from loading.
Learn more about possible network issues or contact support for more help.
No sample available
Title details for Medical Product Regulatory Affairs by John J. Tobin - Available

Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

by John J. Tobin
Gary Walsh

eBook

1 of 1 copy available

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
Publisher: Wiley

Kindle Book

  • Release date: September 8, 2008

PDF eBook

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

1 of 1 copy available

Formats

Kindle Book
PDF eBook

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