Comprehensive Guide to Medical Product Regulatory Affairs

By John J. Tobin, a renowned author in the field of regulatory affairs, this book offers a hands-on guide through the complex jungle of medical regulatory affairs. It is designed for every professional involved in bringing new products to the market.

Overview of the Book

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.

Key Topics Covered

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.

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.

Why This Book?

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.

About the Author

John J. Tobin is a renowned author in the field of regulatory affairs. His extensive experience and knowledge in the field have made him a leading figure in the industry.