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.
| ISBN: | 9783527318773 |
| Publication date: | 9th July 2008 |
| Author: | John J. (ChemHaz Solutions, Clare County, Ireland) Tobin, Gary (University of Limerick, Ireland) Walsh |
| Publisher: | Blackwell Verlag GmbH an imprint of Wiley-VCH Verlag GmbH |
| Format: | Hardback |
| Pagination: | 297 pages |
| Genres: |
Public health and safety law Health systems and services Pharmacology |