Comprehensive Guide to Medical Product Regulatory Affairs

Authored by John J. Tobin, this book serves as a hands-on guide for professionals involved in bringing new medical products to the market. It navigates through the complex jungle of medical regulatory affairs, providing insights into how pharmaceutical and medical devices are regulated within major global markets.

Drug Development and Regulation

The book begins with an overview of drug development, followed by detailed sections on national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. It also covers CDER, CBER, and marketing and manufacturing licenses, the ICH process, and Good Laboratory/Clinical/Manufacturing Practices.

Aims and Structure of Regulation

This section delves into the purpose and principles of regulation, national and EU legislative processes, and pharmacopeia. It provides a comprehensive understanding of regulatory strategy, including product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation.

Drug Discovery and Development

This part of the book focuses on prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery. It offers valuable insights into non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence.

Clinical Trials

The book also covers clinical trials in detail, including trial protocol, monitoring of trials, trial master files, and FDA communications. This information is crucial for understanding the regulatory process and ensuring compliance.

Global Markets and Product Types

Medical Product Regulatory Affairs covers a wide range of product types and major global markets, making it an ideal resource 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 looking to familiarize themselves with the topic.