Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices
 
 
Wiley-Blackwell (Verlag)
1. Auflage | erschienen am 24. August 2011 | 297 Seiten
 
E-Book | ePUB mit Adobe DRM | Systemvoraussetzungen
978-3-527-64471-1 (ISBN)
 
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.

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.
Englisch
17,78 MB
978-3-527-64471-1 (9783527644711)
weitere Ausgaben werden ermittelt

Dateiformat: EPUB
Kopierschutz: Adobe-DRM (Digital Rights Management)

Systemvoraussetzungen:

Computer (Windows; MacOS X; Linux): Installieren Sie bereits vor dem Download die kostenlose Software Adobe Digital Editions (siehe E-Book Hilfe).

Tablet/Smartphone (Android; iOS): Installieren Sie bereits vor dem Download die kostenlose App Adobe Digital Editions (siehe E-Book Hilfe).

E-Book-Reader: Bookeen, Kobo, Pocketbook, Sony, Tolino u.v.a.m. (nicht Kindle)

Das Dateiformat EPUB ist sehr gut für Romane und Sachbücher geeignet - also für "fließenden" Text ohne komplexes Layout. Bei E-Readern oder Smartphones passt sich der Zeilen- und Seitenumbruch automatisch den kleinen Displays an. Mit Adobe-DRM wird hier ein "harter" Kopierschutz verwendet. Wenn die notwendigen Voraussetzungen nicht vorliegen, können Sie das E-Book leider nicht öffnen. Daher müssen Sie bereits vor dem Download Ihre Lese-Hardware vorbereiten.

Weitere Informationen finden Sie in unserer E-Book Hilfe.


Download (sofort verfügbar)

89,90 €
inkl. 19% MwSt.
Download / Einzel-Lizenz
ePUB mit Adobe DRM
siehe Systemvoraussetzungen
E-Book bestellen