Wow! eBook
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices New Edition
Author(s): John J. Tobin (Author), Gary Walsh (Author)
- Publisher: Blackwell Pub
- Publication Date: January 1, 2008
- Edition: New
- Language: English
- Print length: 283 pages
- ISBN-10: 9783527318773
- ISBN-13: 9783527318773
Book Description
Viel Information zum attraktiven Preis: In diesem übersichtlich strukturierten, prägnant formulierten Buch finden Sie alle wichtigen gesetzlichen Vorschriften für den internationalen Pharma- und Medizingerätemarkt. Nach einer kurzen Einführung in den Prozess der Wirkstoffentwicklung und -zulassung werden nationale Bestimmungen, EU-Recht, USA-Recht, die Vergabe von Herstell- und Vermarktungslizenzen, CDER-/CBER-Richtlinien sowie relevante Teile von GLP, GCP und GMP behandelt.
Editorial Reviews
Review
“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)
About the Author
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.
