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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.

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  • ""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."@en

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  • "Electronic books"@en

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  • "Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices"
  • "Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices"@en
  • "Medical product regulatory affairs pharmaceuticals, diagnostics, medical devices"
  • "Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices"

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