000			01440nam a2200169Ia 4500
008			140223b2008 xxu||||| |||| 00| 0 eng d
020			_a9783527318773 _c0.00
082			_a615.7 _bTOB
100			_aTobin, John J. _919337
245			_aMedical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
260			_aNew York _bWiley-VCH _c2008
300			_a283p
500			_a"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.
700			_aWalsh, Gary _916733
942			_2ddc _cLB _k615.7 _mTOB
995			_aPharmacy Reference _eP0006149 _j615.7 _yP0006149
999			_c15799 _d15799