Medical Product Regulatory Affairs
Pharmaceuticals, Diagnostics, Medical Devices
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Medical Product Regulatory Affairs by Gary Walsh
Book Description"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.
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Book DetailsISBN: 9783527318773
(246mm x 176mm x 20mm)
Imprint: Wiley-VCH Verlag GmbH
Publisher: Wiley-VCH Verlag GmbH
Publish Date: 9-Jul-2008
Country of Publication: Germany
Books By Author Gary Walsh
Proteins, Paperback (May 2014)
Proteins Biochemistry and Biotechnology 2e is a definitive source of information for all those interested in protein science, and particularly the commercial production and isolation of specific proteins, and their subsequent utilization for applied purposes in industry and medicine.
Post-translational Modification of Protein Biopharmaceuticals, Hardback (April 2009)
From the leading author in the field, known around the world for his work and his authoritative publications, the contents of this book have been selected so as to reflect their relative importance for biopharmaceuticals.
Pharmaceutical Biotechnology, Hardback (July 2007)
Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals.
Biopharmaceuticals, Paperback (July 2003)» View all books by Gary Walsh
The latest edition of this highly acclaimed textbook, provides a comprehensive and up--to--date overview of the science and medical applications of biopharmaceutical products.
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Author Biography - Gary Walsh
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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