John J. Tobin,Gary Walsh's Medical Product Regulatory Affairs: Pharmaceuticals, PDF

By John J. Tobin,Gary Walsh

ISBN-10: 3527333266

ISBN-13: 9783527333264

Written in a transparent and concise kind through an skilled writer, this attractively-priced booklet covers regulatory affairs in all significant international markets for prescription drugs and scientific units, making it the main entire in its field.
Following a glance at drug improvement, entire sections are dedicated to nationwide and european regulatory concerns, production license software and retention, and law within the united states. different subject matters handled comprise CDER, CBER and advertising and marketing and production licenses, the ICH strategy and reliable Laboratory/Clinical/Manufacturing Practices.
every little thing pharmacologists, bioengineers, pharma engineers, scholars in pharmacy and people operating within the pharmaceutical want to know approximately scientific regulatory affairs.

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Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices by John J. Tobin,Gary Walsh


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