The First-Ever Study of Global GCP Clinical Trial Compliance Programs and Trends!
Learn what the FDA, EMEA, OHRP, and Japan's PMDA see as the GCP compliance "hot spots" today! Developed for clinical sponsors and CRAs, clinical trial administrators, clinical compliance officers, clinical investigators and site staff, clinical QA professionals, and other clinical professionals!
"By far the most comprehensive review of clinical GCP compliance trends and programs in the U.S. (FDA and OHRP), Canada, EU, UK, and Japan."
The Journal of Clinical Research Best Practices (View Full Book Review)
The Global GCP Compliance Report 2006: US, EU, and Japan
As clinical trials are becoming more global in nature and standards for clinical trial conduct are becoming more harmonized, this just-released report presents a first-of-its kind, systematic study of GCP compliance in the world's major markets.
Gain exclusive access to detailed data analyses of GCP compliance trends internationally, profiles of GCP compliance programs within several of the world's key regulatory agencies, and in-depth interviews with GCP compliance officials and GCP field inspectors!
Plus, gain access to the largest compendium of GCP compliance trends and data ever compiled! Learn exactly where regulators such as the FDA, EMEA, US OHRP, UK MHRA, and Japan's PMDA are finding GCP problems, and what their GCP compliance "hot spots" are today.
In The Global GCP Compliance Report, you'll gain access to the following in-depth profiles, compliance data, and interviews:
- FDA GCP Compliance Programs for Drugs, Biologics, and Medical Devices
- Interview with the EMEA's GCP Compliance Administrator Fergus Sweeney, Ph.D.
- The Largest Collection of International GCP Compliance Data Anywhere
- US OHRP Compliance Program/Data for Government-sponsored Research
- UK MHRA's GCP Compliance Program
- Japan's PMDA's GCP Compliance Program and Trend Data
- Interview with FDA Bioresearch Monitoring Specialist/Inspector Mike Rashti
- Interview with FDA CDRH (Devices) BIMO Director Michael Marcarelli
- Interview with FDA CBER (Biologics) BIMO Branch Chief Patricia Holobaugh
- Complete analyses of investigator, sponsor/monitor, and IRB GCP compliance deficiencies in warning letters/regulatory notifications
- Interview with FDA's CDER BIMO Director Joanne Rhoads, M.D.
- Interview with Health Canada's Good Clinical Practices Unit Coordinator Jean Saint-Pierre
Approx. 180 pages, ISBN# 1-882615-75-1.