Medical Product Regulatory Affairs

Building on the success of its predecessor, this second edition of the hands-on guide to how pharmaceutical and medical devices are regulated within the major global markets has an even wider scope and now features case studies. The new EU-framework and US regulations are also fully integrated. The textbook is based on a module prepared by the authors for an MSc course. This and its broad coverage make it an ideal resource for training purposes in both industry and academia. It is equally a valuable reference for all scientists needing to familiarize themselves with the topic. Zusatztext

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 chair of industrial biotechnology at the University of Limerick, Ireland. He has direct industrial experience within the pharmaceutical and diagnostic industries, as well as extensive teaching and research interests in the pharmaceutical and biotechnology arena.