Good Clinical Practice: A Question & Answer Reference Guide, May 2012 - Softcover

Softcover

ISBN 10: 1882615980 ISBN 13: 9781882615988

Synopsis

Newly updated and expanded for 2012, this industry-leading GCP training and reference guide answers approximately 800 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP standards for and biologics. While continuing with a U.S./FDA focus, this innovative reference guide has now been expanded to provide even more information on not just US GCP, but international GCP issues in such regions and countries as the European Union, India, Latin America and Russia! Find out for yourself why more and more leading pharma and biotech companies are using this reference guide to educate their clinical professionals, trial auditors, and site staff on the many emerging complexities of GCP standards. With the completely updated and expanded 2012 guide, there are completely updated sections featuring all the latest data and trends on the FDA and EMA's clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance;
200+ Q&As updated to reflect the very latest FDA guidances, regulations, comments, and developments;
Revised and updated sections on GCP compliance and clinical trial requirements in numerous regions of the world outside the US, such as Canada, Latin America, India, and Eastern Europe.

Edition details

• Language: English
• ISBN 10: 1882615980
• ISBN 13: 9781882615988
• Binding: Spiral-bound