TY - BOOK
T1 - Medical Product Regulatory Affairs
T2 - Pharmaceuticals, Diagnostics, Medical Devices
AU - Tobin, John J.
AU - Walsh, Gary
PY - 2008/9/12
Y1 - 2008/9/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84884309043&partnerID=8YFLogxK
U2 - 10.1002/9783527623037
DO - 10.1002/9783527623037
M3 - Book
AN - SCOPUS:84884309043
SN - 9783527318773
BT - Medical Product Regulatory Affairs
PB - Wiley-VCH
ER -