Anbieter: Romtrade Corp., STERLING HEIGHTS, MI, USA
Zustand: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.
EUR 279,19
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In den WarenkorbZustand: New. Brian R. Matthews, Anthony C. CartwrightDiscover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory .
Sprache: Englisch
Verlag: Taylor & Francis Inc Aug 2009, 2009
ISBN 10: 1420081764 ISBN 13: 9781420081763
Anbieter: AHA-BUCH GmbH, Einbeck, Deutschland
Buch. Zustand: Neu. Neuware - Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.