Average Reviews:
(More customer reviews)written in a technically precise and easy-going manner, it covers well all items listed in the index. Allocation of tables and pictures sometimes far from the page one is reading, but no harm done. Overall it is an excellent book to align a team of RA professionals with the basics of the area.
Click Here to see more reviews about: Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
"This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing." –Microbiology Today, May 2009
Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.
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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices.
The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
No comments:
Post a Comment