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.