Medical Product Regulatory Affairs

Medical Product Regulatory Affairs, Gary  Walsh audiobook. ISDN43557200

Gary Walsh and John Tobin

Genre:foreign educational literature

Language:English

Type:PDF book

Publisher:John Wiley & Sons Limited

Publication date:08.12.2022

Price:$164.46

Views:30

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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