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Medical Product Regulatory Affairs

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Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

John J. Tobin, Gary Walsh

Wiley-Blackwell
Publication date : 2008-09-08

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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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About the book

Author

John J. Tobin , Gary Walsh

Imprint

Wiley-Blackwell

Collection

n.c

Publication date

2008-09-08

Pages

297 pages

Print ISBN

9783527318773

Language

English

Ebook informations

EAN PDF

9783527623044

Price

£88.57

Copy count 0

Print count 297

File size 10619 Ko

Informations accessibility

EAN EPUB

9783527644711

Price

£88.57

Copy count 0

Print count 297

File size 17777 Ko

Informations accessibility

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About author(s)

John J. Tobin

Gary Walsh

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