Medical Product Regulatory Affairs —— Pharmaceuticals, Diagnostics, Medical Devices

----- 医药产品规章事务 - 医药品，诊断学、医疗器械

ISBN: 9783527318773 出版年：2011 页码：299 John J Tobin Gary Walsh Wiley

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.