Medical Product Regulatory Affairs

Medical Product Regulatory Affairs

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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.US Regulations FDC Act Section 510, Registration of producers of drugs and devices Establishment Registration: 21 ... FDA Compliance Programme Guidance Manual Programme 7536.002, Drug Manufacturing Inspections FDA Guide toanbsp;...


Title:Medical Product Regulatory Affairs
Author: John J. Tobin, Gary Walsh
Publisher:John Wiley & Sons - 2011-08-24
ISBN-13:

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