Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices

Front Cover
John Wiley & Sons, Sep 2, 2008 - Science - 297 pages
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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Contents

Preface XIII
6
Regulatory Strategy
21
Medical Product Regulatory Affairs John J Tobin and Gary Walsh
43
NonClinical Studies
57
Clinical Trials
73
Authorisation of Veterinary Medicines
129
Medical Devices
167
Authorisation of Medical Devices
187
Good Manufacturing Practice GMP
209
Oversight and Vigilance
237
Index
277
Copyright

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About the author (2008)

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. He also teaches elements of pharmaceutical science and regulatory affairs on an annual course provided by the University of Limerick to an international medical device company with a manufactoring facility based in the region.

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