Medical Product Regulatory Affairs

Pharmaceuticals, Diagnostics, Medical Devices

Tobin, John J. / Walsh, Gary

1. Edition July 2008
XIV, 283 Pages, Hardcover
114 Pictures (1 Colored Figures)
39 tables
Textbook

ISBN: 978-3-527-31877-3

Wiley-VCH, Weinheim

Wiley Online Library Content Sample Chapter Index

Short Description

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

Buy now

Price: 97,90 €

Price incl. VAT, excl. Shipping

Euro prices for Wiley-VCH and Ernst & Sohn titles are only valid for Germany. In EU countries, local VAT applies. Postage will be charged.

- Out of print -

Further versions

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.

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