Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
By: and
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- Synopsis
- 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.
- Copyright:
- 2011
Book Details
- Book Quality:
- Publisher Quality
- Book Size:
- 297 Pages
- ISBN-13:
- 9783527644711
- Related ISBNs:
- 9783527318773, 9783527623037
- Publisher:
- Wiley
- Date of Addition:
- 05/27/20
- Copyrighted By:
- WILEY-VCH Verlag GmbH & Co
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.