Medical Product Regulatory Affairs Pharmaceuticals, Diagnostics, Medical Devices

by Tobin, John J.; Walsh, Gary

• ISBN13: 9783527318773
• ISBN10: 3527318771
• Edition: 1st
• Format: Hardcover
• Copyright: 2008-09-02
• Publisher: Wiley-Blackwell

Summary

Written in a clear and concise by experienced authors, this book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices.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.The book covers everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Author Biography

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.

Table of Contents

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

Table of Contents provided by Publisher. All Rights Reserved.