Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
September 2008, Wiley-Blackwell
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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.
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Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices (US $119.95)
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