Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices
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.
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Medical Product Regulatory Affairs John J Tobin and Gary Walsh
Authorisation of Veterinary Medicines
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according action active administration adverse animals Annex application appropriate approval assessment biological body changes Chapter Class clinical trials Code Committee Competent Authorities conducted contain Directive distribution documents drug drug product effects efficacy ensure equipment establish European evaluation example existing facilities Figure final guidance human identified indications initial inspection intended investigations involved issues labelling maintained manufacturing marketing authorisation materials measures medical devices medicinal products Member methods operations outlined packaging patient performance person pharmaceutical Phase practice prevent principles procedures proposed protocol quality system records reference regulations regulatory relating relevant requirements residues responsible risk safety samples shown specific sponsor Stability standards studies subjects submission submitted substance Summary Table testing therapeutic Title treatment validation veterinary medicinal