Wiley-VCH, Weinheim Medical Product Regulatory Affairs Cover All you need to know about regulatory affairs in the major global markets for pharmaceuticals and me.. Product #: 978-3-527-31877-3 Regular price: $89.43 $89.43 Auf Lager

Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

Tobin, John J. / Walsh, Gary

Cover

1. Auflage Juli 2008
XIV, 283 Seiten, Hardcover
114 Abbildungen (1 Farbabbildungen)
39 Tabellen
Lehrbuch

ISBN: 978-3-527-31877-3
Wiley-VCH, Weinheim

Kurzbeschreibung

All you need to know about regulatory affairs in the major global markets for pharmaceuticals and medical devices.

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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.

What is a drug, and what is a device? Basic principles and definitions of healthcare products
The regulatory framework: FDA, EMEA, other regulatory authorities
The drug development process: pre-clinical and clinical studies
Medical devices: design control, validation, risk management
Regulatory submissions: forms and requirements
Quality systems: GMP, ISO norms, software validation
Post-marketing issues: surveillance, corrective and preventive actions
World harmonization of regulatory requirements
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.

J. J. Tobin, ChemHaz Solutions, Clare County, Ireland; G. Walsh, University of Limerick, Limerick, Ireland