Medical Product Regulatory Affairs

Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market

Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of 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.

Medical Product Regulatory Affairs includes information on:

• Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia
• Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation
• Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery
• Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence
• Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications

The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.

John J. Tobin worked for many years and in various capacities within Olympus diagnostica GmbH, a company that employed several 100 people to develop and manufacture in vitro diagnostic reagents.

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.