Regulations and ethics are the backbone of clinical research--without a solid understanding of the fundamentals, your work product may not substantiate desired claims or support marketing applications. Furthermore, in this age of global economics you will get the most value for your dollar if studies meet requirements of both US and Europe. This comprehensive review of US and EU regulations brings them to life with practical case studies, helping you benchmark you company's interpretations against others'. 300+ page reference work. Indexed. Tables and illustrations. For more information consult our catalog.
Contents
Stark NJ, Applied Regulations, Third Edition, Clinical
Device Group Inc, Chicago, IL. (2002). Perfect bound,
illustrated, ISBN 1-889160-03-2. $250 US.
Close-up: United States
Part 812
Sea Change in America
Import and Export
Close-Up: European Union Directive
The Standards: EN 540 and ISO 14155
France
Germany
The Netherlands
United Kingdom
Close-up: World Health Organization
Tips for International Trials