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Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices

by Gary Walsh, John J. Tobin

Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices Synopsis

This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing. -Microbiology Today, May 2009 Written in a clear and concise style by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices. 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 include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices Press Reviews

This book is an excellent reference for people starting out in regulatory affairs, as well as those working within the area whose product portfolio is adapting and changing. ( Microbiology Today , May 2009)

Book Information

ISBN: 9783527318773
Publication date: 9th July 2008
Author: Gary Walsh, John J. Tobin
Publisher: Wiley-VCH Verlag GmbH
Format: Hardback
Pagination: 297 pages
Categories: Public health & safety law, Health systems & services, Pharmacology,

About Gary Walsh, John J. Tobin

J.J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company employing several 100 people who develop and manufacture in vitro diagnostic reagents. Dr. Tobin therefore has extensive experience of working within an FDA and European medical device regulatory framework. Gary Walsh is a senior lecturer in industrial biochemistry at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical industry, as well as extensive teaching and non-laboratory based research interests in the pharmaceutical biotechnology arena. He has published a number of books, book chapters and journal articles relevant to this publication. ...

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