Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical Devices - Rilegato

Tobin, John J.; Walsh, Gary

Rilegato

ISBN 10: 3527333266 ISBN 13: 9783527333264

Casa editrice: Vch Pub, 2023

Riassunto

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.

Su questo libro

L'autore:

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 an associate professor of 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 has taught 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 manufacturing facility based in the region.

Su questa edizione

• Editore: Vch Pub
• Data di pubblicazione: 2023
• ISBN 10: 3527333266
• ISBN 13: 9783527333264
• Rilegatura: Copertina rigida
• Numero edizione: 2
• Numero di pagine: 316